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Safety and Efficacy Study of Enzalutamide in Patients With Nonmetastatic Castration-Resistant Prostate Cancer (PROSPER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02003924
Recruitment Status : Active, not recruiting
First Posted : December 6, 2013
Results First Posted : July 12, 2018
Last Update Posted : October 3, 2019
Sponsor:
Collaborators:
Astellas Pharma Inc
Medivation LLC, a wholly owned subsidiary of Pfizer Inc.
Information provided by (Responsible Party):
Pfizer

Brief Summary:
The purpose of this study is to assess the safety and efficacy of enzalutamide in patients with non metastatic prostate cancer.

Condition or disease Intervention/treatment Phase
Nonmetastatic Castration-Resistant Prostate Cancer Prostate Cancer Cancer of the Prostate Drug: Enzalutamide Drug: Placebo Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1401 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: PROSPER: A MULTINATIONAL, PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, EFFICACY AND SAFETY STUDY OF ENZALUTAMIDE IN PATIENTS WITH NONMETASTATIC CASTRATION-RESISTANT PROSTATE CANCER
Actual Study Start Date : October 31, 2013
Actual Primary Completion Date : June 28, 2017
Estimated Study Completion Date : April 28, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Sham Comparator: Placebo
Sugar pill manufactured to mimic enzalutamide 40 mg capsule
Drug: Placebo
Sugar pill to mimic enzalutamide

Experimental: Enzalutamide
160 mg by mouth once daily
Drug: Enzalutamide
160 mg by mouth once daily
Other Names:
  • MDV3100
  • Xtandi




Primary Outcome Measures :
  1. Metastasis Free Survival (MFS) [ Time Frame: From randomization until radiographic progression at any time, or death within 112 days of treatment discontinuation, whichever occurred first (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months) ]
    MFS:time from randomization to first date of radiographic progression (RP) (by Blinded independent central radiology review [BICR]) at any time or death within 112 days of treatment discontinuation without evidence of RP.RP for bone disease:appearance of 1 or more metastatic lesions on bone scan.RP for soft tissue disease:per Response Evaluation Criteria in Solid Tumors,[RECIST 1.1])-at least a 20 percent (%) increase in the sum of diameters of target lesions,taking as reference the smallest sum on study (includes the baseline sum if smallest on study).Participants who did not have MFS event at the time of analysis data cut-off (28 June 2017) were censored at date of last assessment showing no objective evidence of RP prior to skeletal-related event or two or more consecutive missed tumor assessments. Participants who were randomized but later confirmed to have metastatic disease before randomization were censored on date of randomization. Analysis was based on Kaplan-Meier estimates.


Secondary Outcome Measures :
  1. Time to Prostate-Specific Antigen (PSA) Progression [ Time Frame: From randomization until first PSA progression (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months) ]
    Time to PSA progression was defined as the time from randomization to the date of first PSA value demonstrating progression, which was subsequently confirmed. For participants with PSA decline at Week 17, PSA progression was defined according to Prostate Cancer Working Group 2 (PCWG2) guidelines as the date that a 25% or greater increase and an absolute increase of 2 nanograms per milliliter (ng/mL) above the nadir (or baseline for participants with no PSA decline by Week 17) was documented, which was confirmed by a second consecutive value obtained at least 3 weeks or later. Participants without confirmed PSA progression at the time of analysis were right censored at the date of last PSA assessment before the analysis data cut-off date for the purposes of analysis. Analysis was based on Kaplan-Meier estimates.

  2. Time to First Use of New Antineoplastic Therapy [ Time Frame: From randomization until first use of new antineoplastic therapy(until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months) ]
    Time to first use of new antineoplastic therapy was defined as the time from randomization to first use of new antineoplastic for prostate cancer. Participants not starting treatment with a new antineoplastic therapy at the time of analysis were right censored at the date of last assessment before the analysis data cutoff date for the purposes of analysis. Analysis was based on Kaplan-Meier estimates.

  3. Overall Survival [ Time Frame: From randomization until death or discontinuation from the study whichever occurred first (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months) ]
    Overall survival (OS) was defined as the time (in months) from randomization to death from any cause. For participants who were alive at the time of the analysis data cutoff, OS time was censored at the last date the participant was known to be alive or analysis data cutoff date, whichever was earlier. Participants with no post baseline survival information were censored on the date of randomization. Analysis was based on Kaplan-Meier estimates.

  4. Time to Pain Progression [ Time Frame: From randomization until onset of pain progression (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months) ]
    Pain was assessed using the score from the Brief Pain Inventory-Short Form (BPI-SF) question 3: "Please rate your pain by marking the box beside the number that best describes your pain at its worst in the last 24 hours." Time to this event was defined as the time from randomization to onset of pain progression, where pain progression was defined as a 2-point or more increase from baseline in the question 3 score. Participants without observed pain progression at the time of analysis were right censored at the date of last pain assessment for the purposes of analysis. Analysis was based on Kaplan-Meier estimates.

  5. Time to First Use of Cytotoxic Chemotherapy [ Time Frame: From randomization up to the first use of cytotoxic chemotherapy (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months) ]
    Time to first use of cytotoxic chemotherapy was defined as the time from randomization to the first use of cytotoxic chemotherapy for prostate cancer. Participants not starting treatment with a cytotoxic chemotherapy for prostate cancer at the time of analysis were right censored at the date of last assessment before the analysis data cutoff date for the purposes of analysis. Analysis was based on Kaplan-Meier estimates.

  6. Chemotherapy-Free Disease Specific Survival [ Time Frame: From randomization up to first use of cytotoxic chemotherapy for prostate cancer or death due to prostate cancer (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months) ]
    Chemotherapy-free disease-specific survival was defined as the time from randomization to first use of cytotoxic chemotherapy for prostate cancer or death due to prostate cancer as assessed by the investigator. Participants not starting treatment with a cytotoxic chemotherapy or not known to have died due to prostate cancer at the time of analysis were right censored at the date of last assessment before the analysis data cutoff date for the purposes of analysis. Analysis was based on Kaplan-Meier estimates.

  7. Chemotherapy-Free Survival [ Time Frame: From randomization up to first use of cytotoxic chemotherapy for prostate cancer or death due to any cause (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months) ]
    Chemotherapy-free survival was defined as the time from randomization to first use of cytotoxic chemotherapy for prostate cancer or death due to any cause. Participants not starting treatment with a cytotoxic chemotherapy or not known to have died at the time of analysis were censored at the date of last assessment before the analysis data cutoff date for the purposes of analysis. Analysis was based on Kaplan-Meier estimates.

  8. Percentage of Participants With Prostate Specific Antigen (PSA) Response [ Time Frame: From randomization until first PSA progression (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months) ]
    PSA response was calculated at each visit as a decline from baseline in PSA (ng/mL) to the maximal PSA response with thresholds at 50% and 90%. Additionally, PSA response was assessed as a decline to undetectable levels, where undetectable level was defined as below the limit of quantification of the centrally assessed PSA results (the lower limit of quantification was 0.02 ng/mL). PSA response was confirmed by a second consecutive value at least 3 weeks later.

  9. Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score [ Time Frame: Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177 ]
    The FACT-P questionnaire is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, functional well-being, and supplemented by 12 site-specific items to assess prostate-related symptoms. Each item was rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain, as well as a global quality of life score which ranged from 0 to 156 where higher scores represented better quality of life.

  10. Number of Participants With European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Mobility Domain Score [ Time Frame: Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177 ]
    EQ-5D-5L is a standardized instrument that measures health-related quality of life for men with prostate cancer. EQ-5D consists of EQ-5D descriptive system and EQ visual analogue scale (VAS). EQ-5D descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Number of participants with various responses to the mobility questionnaire are reported.

  11. Number of Participants With European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Self-Care Domain Score [ Time Frame: Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177 ]
    EQ-5D-5L is a standardized instrument that measures health-related quality of life for men with prostate cancer. EQ-5D consists of EQ-5D descriptive system and EQ VAS. EQ-5D descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Number of participants with various responses to the self-care questionnaire are reported.

  12. Number of Participants With European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Usual Activities Domain Score [ Time Frame: Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177 ]
    EQ-5D-5L is a standardized instrument that measures health-related quality of life for men with prostate cancer. EQ-5D consists of EQ-5D descriptive system and EQ visual analogue scale (VAS). EQ-5D descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Number of participants with various responses to the usual activities questionnaire are reported.

  13. Number of Participants With European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Pain/Discomfort Domain Score [ Time Frame: Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177 ]
    EQ-5D-5L is a standardized instrument that measures health-related quality of life for men with prostate cancer. EQ-5D consists of EQ-5D descriptive system and EQ visual analogue scale (VAS). EQ-5D descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Number of participants with various responses to the pain/discomfort questionnaire are reported.

  14. Number of Participants With European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Anxiety/ Depression Domain Score [ Time Frame: Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177 ]
    EQ-5D-5L is a standardized instrument that measures health-related quality of life for men with prostate cancer. EQ-5D consists of EQ-5D descriptive system and EQ visual analogue scale (VAS). EQ-5D descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Number of participants with various responses to the anxiety/depression questionnaire are reported.

  15. European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Overall Health Status Visual Analog Score (VAS) [ Time Frame: Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177 ]
    EQ-5D-5L is a standardized instrument that measures health-related quality of life for men with prostate cancer. EQ-5D consists of EQ-5D descriptive system and EQ VAS. EQ-5D-5L-VAS records participant's self-rated health on a vertical VAS that allows them to indicate their health state that can range from 0 (worst imaginable) to 100 (best imaginable), higher scores indicating a better health state.

  16. Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 31 [ Time Frame: Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177 ]
    The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 31 are reported. Question 31 was following: "Have you had to urinate frequently during the day?"

  17. Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 32 [ Time Frame: Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177 ]
    The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 32 are reported. Question 32 was following: "Have you had to urinate frequently at night?"

  18. Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 33 [ Time Frame: Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177 ]
    The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 33 are reported. Question 33 was following: "When you felt the urge to pass urine, did you have to hurry to get to the toilet?"

  19. Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 34 [ Time Frame: Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177 ]
    The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 34 are reported. Question 34 was following: "Was it difficult for you to get enough sleep, because you needed to get up frequently at night to urinate?"

  20. Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 35 [ Time Frame: Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177 ]
    The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 35 are reported. Question 35 was following: "Have you had difficulty going out of the house because you needed to be close to a toilet?"

  21. Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 36 [ Time Frame: Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177 ]
    The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 36 are reported. Question 36 was following: "Have you had any unintentional release (leakage) of urine?"

  22. Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 37 [ Time Frame: Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177 ]
    The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 37 are reported. Question 37 was following: "Did you have pain when you urinated?"

  23. Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 38 [ Time Frame: Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177 ]
    The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 38 are reported. Question 38 was following: "Has wearing an incontinence aid been a problem for you?". This question was answered by only those participants who wore incontinence aid.

  24. Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 39 [ Time Frame: Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177 ]
    The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 39 are reported. Question 39 was following: "Have your daily activities been limited by your urinary problems?"

  25. Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 40 [ Time Frame: Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177 ]
    The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 40 are reported. Question 40 was following: "Have your daily activities been limited by your bowel problems?"

  26. Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 41 [ Time Frame: Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177 ]
    The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 41 are reported. Question 41 was following: "Have you had any unintentional release (leakage) of stools?"

  27. Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 42 [ Time Frame: Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177 ]
    The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 42 are reported. Question 42 was following: "Have you had blood in your stools?"

  28. Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 43 [ Time Frame: Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177 ]
    The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 43 are reported. Question 43 was following: "Did you have a bloated feeling in your abdomen?"

  29. Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 44 [ Time Frame: Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177 ]
    The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 44 are reported. Question 44 was following: "Did you have hot flushes?"

  30. Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 45 [ Time Frame: Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177 ]
    The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 45 are reported. Question 45 was following: "Have you had sore or enlarged nipples or breasts?"

  31. Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 46 [ Time Frame: Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177 ]
    The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 46 are reported. Question 46 was following: "Have you had swelling in your legs or ankles?"

  32. Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 47 [ Time Frame: Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177 ]
    The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 47 are reported. Question 47 was following: "Has weight loss been a problem for you?"

  33. Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 48 [ Time Frame: Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177 ]
    The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 48 are reported. Question 48 was following: "Has weight gain been a problem for you?"

  34. Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 49 [ Time Frame: Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177 ]
    The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 49 are reported. Question 49 was following: "Have you felt less masculine as a result of your illness or treatment?"

  35. Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 50 [ Time Frame: Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177 ]
    The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 50 are reported. Question 50 was following: "To what extent were you interested in sex?"

  36. Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 51 [ Time Frame: Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177 ]
    The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 51 are reported. Question 51 was following: "To what extent were you sexually active (with or without intercourse)?"

  37. Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 52 [ Time Frame: Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177 ]
    The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 52 are reported. Question 52 was following: "To what extent was sex enjoyable for you?"

  38. Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 53 [ Time Frame: Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177 ]
    The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 53 are reported. Question 53 was following: "Did you have difficulty getting or maintaining an erection?"

  39. Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 54 [ Time Frame: Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177 ]
    The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 54 are reported. Question 54 was following: "Did you have ejaculation problems (e.g, dry ejaculation)?"

  40. Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 55 [ Time Frame: Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177 ]
    The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 55 are reported. Question 55 was following: "Have you felt uncomfortable about being sexually intimate?"

  41. Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: From first dose of study drug to the last dose + 30 days (or the day before initiation of a new antineoplastic treatment, whichever occurred first) (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months) ]
    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment-emergent AE (TEAE) was defined as an AE that occurred from the date and time of the first dose of study drug through the date of last dose +30 days (or the day before initiation of a new antineoplastic treatment, whichever occurred first). AEs included both non-serious adverse events (AEs) and SAEs.

  42. Number of Participants With Treatment-Emergent Adverse Events Greater Than or Equal to Grade 3, Based on National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE), Version 4.0 [ Time Frame: From first dose of study drug to the last dose + 30 days (or the day before initiation of a new antineoplastic treatment, whichever occurred first) (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months) ]
    An AE is any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. As per NCI CTCAE, Grade 3 events =medically significant but not immediately life-threatening, unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment, Grade 4 events =participant to be in imminent danger of death. Grade 5 events =death. A treatment-emergent AE (TEAE) was defined as an AE that occurred from the date and time of the first dose of study drug through the date of last dose +30 days (or the day before initiation of a new antineoplastic treatment, whichever occurred first).Number of participants with AEs of any of the Grade 3 or above (Grade 4, 5) were reported.

  43. Number of Participants With Discontinuations From Study Treatment Due to Adverse Events (AEs) [ Time Frame: From first dose of study drug to the last dose + 30 days (or the day before initiation of a new antineoplastic treatment, whichever occurred first) (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months) ]
    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both non-serious adverse events (AEs) and SAEs.

  44. Number of Participants With Increase of 2 or More National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) (Version 4.0) Toxicity Grades Above Baseline - Hematology [ Time Frame: From first dose of study drug to the last dose + 30 days (or the day before initiation of a new antineoplastic treatment, whichever occurred first) (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months) ]
    Hematology parameters: Haemoglobin (grams per liter [g/L]); leukocytes (log 10 raised to power 9 per liter [10*9/L]); lymphocytes (log 10 raised to power 6 per liter [10*6/L]); neutrophils (log 10 raised to power 6 per liter [10*6/L]); platelets (log 10 raised to power 9 per litre [10*9/L]).

  45. Number of Participants With Increase of 2 or More National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) (Version 4.0) Toxicity Grades Above Baseline - Chemistry [ Time Frame: From first dose of study drug to the last dose + 30 days (or the day before initiation of a new antineoplastic treatment, whichever occurred first) (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months) ]
    Chemistry parameters: Alanine aminotransferase (units per liter [U/L]); albumin (g/L); alkaline phosphatase (U/L); bilirubin (micromoles per liter [umol/L]); calcium (millimoles per liter [mmol/L]); creatine kinase (U/L); creatinine (umol/L); glucose, magnesium, phosphate, potassium, sodium (mmol/L).

  46. Number of Participants With Clinically Significant Vital Signs [ Time Frame: From first dose of study drug to the last dose + 30 days (or the day before initiation of a new antineoplastic treatment, whichever occurred first) (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months) ]
    Vital signs included Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP) and heart rate.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation, signet cell, or small cell features;
  • Ongoing androgen deprivation therapy with a gonadotropin-releasing hormone (GnRH) agonist/antagonist or prior bilateral orchiectomy (medical or surgical castration);
  • Testosterone ≤ 50 ng/dL (≤ 1.73 nmol/L) at screening;
  • Progressive disease on androgen deprivation therapy at enrollment;
  • PSA and the screening PSA assessed by the central laboratory (central PSA) should be ≥ 2 µg/L (2 ng/mL:
  • PSA doubling time ≤ 10 months;
  • No prior or present evidence of metastatic disease;
  • Asymptomatic prostate cancer;
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
  • Estimated life expectancy ≥ 12 months.

Exclusion Criteria:

  • Prior cytotoxic chemotherapy;
  • Use of hormonal therapy or biologic therapy for prostate cancer (other than approved bone targeting agents and GnRH agonist/antagonist therapy) or use of an investigational agent within 4 weeks of randomization;
  • Known or suspected brain metastasis or active leptomeningeal disease;
  • History of another invasive cancer within 3 years of randomization;
  • Absolute neutrophil count < 1000/μL, platelet count < 100,000/μL, or hemoglobin < 10 g/dL (6.2 mmol/L) at screening;
  • Total bilirubin ≥ 1.5 times the upper limit of normal;
  • Creatinine > 2 mg/dL (177 µmol/L) at screening;
  • Albumin < 3.0 g/dL (30 g/L) at screening;
  • History of seizure or any condition that may predispose to seizure;
  • Clinically significant cardiovascular disease;
  • Gastrointestinal disorder affecting absorption;
  • Major surgery within 4 weeks of randomization;
  • Hypersensitivity reaction to the active pharmaceutical ingredient or any of the capsule components, including Labrasol, butylated hydroxyanisole, and butylated hydroxytoluene;
  • Any concurrent disease, infection, or comorbid condition that interferes with the ability of the patient to participate in the trial, which places the patient at undue risk, or complicates the interpretation of data, in the opinion of the investigator or medical monitor.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02003924


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Locations
Layout table for location information
United States, Arizona
Urological Associates of Southern Arizona, PC
Tucson, Arizona, United States, 85741
United States, California
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States, 90095
UCLA Clark Urology Center
Los Angeles, California, United States, 90095
University of California, Irvine Medical Center
Orange, California, United States, 92868
Urology Associates of San Luis Obispo, a Medical Group, Inc
San Luis Obispo, California, United States, 93405
United States, Colorado
Urology Associates, P.C.
Englewood, Colorado, United States, 80113
United States, Connecticut
c/o Lynn Buchwalder
New Haven, Connecticut, United States, 06510
C/O Thomas Ferencz, RPh, BCOP, Smilow Cancer Hospital at Yale-New Haven
New Haven, Connecticut, United States, 06510
Smilow Cancer Center at Yale New Haven-Hospital
New Haven, Connecticut, United States, 06510
Yale New Haven Hospital
New Haven, Connecticut, United States, 06510
Yale University School of Medicine
New Haven, Connecticut, United States, 06520
United States, Florida
Lakeland Regional Cancer Center
Lakeland, Florida, United States, 33805
United States, Indiana
Urology of Indiana, LLC
Carmel, Indiana, United States, 46032
First Urology, PSC
Jeffersonville, Indiana, United States, 47130
IU Health Arnett Cancer Care
Lafayette, Indiana, United States, 47904
United States, Kansas
Kansas City Urology Care, PA
Overland Park, Kansas, United States, 66211-1231
GU Research Network/ Wichita Urology Group
Wichita, Kansas, United States, 67226
United States, Maryland
Chesapeake Urology Research Associates
Baltimore, Maryland, United States, 21237
United States, Michigan
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109
Michigan Institute of Urology
Troy, Michigan, United States, 48084
United States, Nebraska
GU Research Network
Omaha, Nebraska, United States, 68130
United States, New York
Brooklyn Urology Research Group
Brooklyn, New York, United States, 11201
Premier Medical Group of the Hudson Valley
Newburgh, New York, United States, 12550
United States, North Carolina
Duke University Medical Center
Cary, North Carolina, United States, 27518
Carolina Urology Partners, PPLC
Charlotte, North Carolina, United States, 28277
Carolina Urology Partners, PLLC
Gastonia, North Carolina, United States, 28054
Gaston Medical Associates
Gastonia, North Carolina, United States, 28054
Duke Women's Cancer Care Raleigh
Raleigh, North Carolina, United States, 27607
United States, Ohio
Clinical Research Solutions
Middleburg Heights, Ohio, United States, 44130
United States, Oregon
Oregon Urology Institute
Springfield, Oregon, United States, 97477
United States, Pennsylvania
Lancaster Urology
Lancaster, Pennsylvania, United States, 17604
United States, South Carolina
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States, 29572
United States, Tennessee
Vanderbilt University Medical Center, Dept. of Urologic Surgery
Nashville, Tennessee, United States, 37232
Vanderbilt University Medical Center, The Urologic Clinic
Nashville, Tennessee, United States, 37232
United States, Texas
Urology San Antonio (CT scans)
San Antonio, Texas, United States, 78229
Urology San Antonio Research
San Antonio, Texas, United States, 78229
United States, Virginia
Urology of Virginia, PLLC.
Virginia Beach, Virginia, United States, 23462
Argentina
COIBA(Centro de Oncologia e Investigacion Buenos Aires)
Berazategui, Buenos Aires, Argentina, B1884BBF
Centro Medico Austral(OMI)
Caba, Buenos Aires, Argentina, C1019ABS
Centro de Urologia
Caba, Buenos Aires, Argentina, C1120AAT
Hospital Italiano de Buenos Aires
Caba, Buenos Aires, Argentina, C1199BB
Sanatorio Parque
Rosario, Santa FE, Argentina, CP2000
Instituto De Oncologia De Rosario
Rosario, Santa FE, Argentina, S200KZE
Clinica Universidad Reina Fabiola
Cordoba, Argentina, X5004HFP
Hospital Privado Centro Medico de Cordoba
Cordoba, Argentina, X5016KEH
Centro Oncologico Riojano Integral (CORI)
La Rioja, Argentina, F5300C0E
Australia, Australian Capital Territory
The Canberra Hospital
Garran, Australian Capital Territory, Australia, 2605
Australia, New South Wales
Border Medical Oncology Research Unit
Albury, New South Wales, Australia, 2640
The Border Cancer Hospital Dispensary
Albury, New South Wales, Australia, 2640
The Border Cancer Hospital
Albury, New South Wales, Australia, 2640
Sydney cancer centre
Concord, New South Wales, Australia, 2139
Epic pharmacy
Lismore, New South Wales, Australia, 2480
North Coast Cancer Institute
Lismore, New South Wales, Australia, 2480
Macquarie University Hospital
North Ryde, New South Wales, Australia, 2109
Macquarie University
North Ryde, New South Wales, Australia, 2109
Epic Pharmacy Port Macquarie base hospital
Port Macquarie, New South Wales, Australia, 2444
Mid North Coast Cancer Institute
Port Macquarie, New South Wales, Australia, 2444
Royal North Shore Hospital
St Leonards, New South Wales, Australia, 2065
The Tweed Hospital
Tweed Heads, New South Wales, Australia, 2485
Australian Clinical Trials
Wahroonga, New South Wales, Australia, 2076
Sydney Adventist Hospital
Wahroonga, New South Wales, Australia, 2076
Calvary Mater Newcastle
Waratah, New South Wales, Australia, 2298
Westmead Hospital
Westmead, New South Wales, Australia, 2145
Australia, Queensland
Icon Cancer Care Wesley
Auchenflower, Queensland, Australia, 4066
River City Pharmacy - APHS
Auchenflower, Queensland, Australia, 4066
Icon Cancer Care Chermside
Chermside, Queensland, Australia, 4032
Icon Cancer Care South Brisbane
South Brisbane, Queensland, Australia, 4101
Icon Cancer Care
South Brisbane, Queensland, Australia, 4101
Icon Cancer Foundation
South Brisbane, Queensland, Australia, 4101
Integrated Clinical Oncology Network (ICON)
South Brisbane, Queensland, Australia, 4101
Icon Cancer Care Southport
Southport, Queensland, Australia, 4215
Tasman Health Care Pharmacy
Southport, Queensland, Australia, 4215
Tasman Oncology Research Pty Ltd
Southport, Queensland, Australia, 4215
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia, 4102
Australia, South Australia
Adelaide Cancer Centre
Kurralta Park, South Australia, Australia, 5037
Ashford Cancer Centre Research
Kurralta park, South Australia, Australia, 5037
Cancer Care SA Pty Ltd
Kurralta Park, South Australia, Australia, 5037
Cancer Care SA trading as Icon Pharmacy Adelaide
Kurralta Park, South Australia, Australia, 5037
Australia, Victoria
Southern Urology
Bentleigh East, Victoria, Australia, 3145
Box Hill Hospital (Eastern health)
Box Hill, Victoria, Australia, 3128
Eastern Clinical Research Unit (Eastern Health)
Box Hill, Victoria, Australia, 3128
Cabrini Hospital Brighton
Brighton, Victoria, Australia, 3186
Monash Medical Centre
Clayton, Victoria, Australia, 3168
Monash Cancer Centre
East Bentleigh, Victoria, Australia, 3165
Austin Health, Austin Hospital
Heidelberg, Victoria, Australia, 3084
Cabrini Hospital Malvern
Malvern, Victoria, Australia, 3144
Cabrini Hospital- Education and Research Precinct
Malvern, Victoria, Australia, 3144
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia, 3000
Sunshine Hospital
St Albans, Victoria, Australia, 3021
Austria
Krankenhaus Barmherzige Schwestern Linz, Abteilung Radiologie
Linz, Upper Austria, Austria, 4010
Krankenhaus Barmherzige Schwestern Linz, Abteilung Urologie
Linz, Upper Austria, Austria, 4010
St. Vincent's Hospital, PET - CT Center
Linz, Upper Austria, Austria, 4010
Isotopix, Ambulatorium fuer Nuklearmedizin
Vienna, Austria, 1090
Medizinische Universitaet Wien, Universitaetsklinik fuer Innere Medizin I
Vienna, Austria, 1090
Diagnosezentrum Meidling GesmbH
Vienna, Austria, 1120
Belgium
Algemeen Ziekenhuis Groeninge
Kortrijk, West-vlaanderen, Belgium, 8500
Clinique Universitaire de Bruxelles Hopital Erasme
Bruxelles, Belgium, 1070
Cliniques universitaires saint-Luc
Bruxelles, Belgium, 1200
Vzw Algemeen Ziekenhuis Maria Middelares
Gent, Belgium, 9000
Universitaire Ziekenhuizen Leuven
Leuven, Belgium, 3000
Centre Hospitalier Universitaire de Liege, Site du Sart-Tilman
Liege, Belgium, 4000
Brazil
Hospital Sao Rafael
Salvador, Bahia, Brazil, 41253-190
Liga Paranaense de Combate ao cancer / Hospital Erasto Gaertner
Curitiba, Parana, Brazil, 81520-060
Associacao Hospital de Caridade de Ijui
Ijui, RIO Grande DO SUL, Brazil, 98700-000
Hospital da Cidade de Passo Fundo
Passo Fundo, RIO Grande DO SUL, Brazil, 99010-260
Hospital de Clinicas de Porto Alegre
Porto Alegre, RIO Grande DO SUL, Brazil, 90035-903
CLINIONCO - Clinica de Oncologia de Porto Alegre Ltda.
Porto Alegre, RIO Grande DO SUL, Brazil, 90430-090
Hospital Sao Lucas da PUCRS
Porto Alegre, RIO Grande DO SUL, Brazil, 90610-000
Instituto D'or de Pesquisa e Ensino
Rio de Janeiro, RJ, Brazil, 22.281-100
Hospital Amaral Carvalho - Fundacao Dr. Amaral Carvalho
Jau, SAO Paulo, Brazil, 17210-080
Fundacao Dr. Amaral Carvalho
Jau, SAO Paulo, Brazil, 17210-120
Fundacao Dr.Amaral Carvalho
Jau, SAO Paulo, Brazil, 17210-120
Hospital Israelita Albert Einstein
Sao Paulp, SAO Paulo, Brazil, 05652-900
Hospital das Clinicas da Faculdade de Ciencias Medicas da UNICAMP
Campinas, SP, Brazil, 13083-970
Centro de Estudos e Pesquisas em Hematologia e Oncologia (CEPHO)
Santo Andre, SP, Brazil, 09060-650
IAMSPE-Inst. de Assist. ao Servidor Publico Estadual
Sao Paulo, SP, Brazil, 04039-901
Hospital Universitario Pedro Ernesto - UERJ
Rio de Janeiro, Brazil, 20551-030
Oncologia Rede D'Or
Rio de Janeiro, Brazil, 22271-110
Canada, Alberta
Tom Baker Cancer Centre
Calgary, Alberta, Canada, T2N 4N2
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
Vancouver Prostate Centre
Vancouver, British Columbia, Canada, V5Z 1M9
Canada, Manitoba
Manitoba Prostate Centre CancerCare Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, Nova Scotia
NS Health Authority, Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, Canada, B3H 2Y9
Canada, Ontario
The Male/Female Health and Research Centre
Barrie, Ontario, Canada, L4M 7G1
McMaster Institute of Urology @ St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada, L8N 4A6
Urology Associates / Urologic Medical Research
Kitchener, Ontario, Canada, N2N 2B9
London Regional Cancer Program - Victoria Hospital, London Health Sciences Centre(LHSC)
London, Ontario, Canada, N6A 4L6
Urology Reasearch - Victoria Hospital, London Health Sciences Centre(LHSC)
London, Ontario, Canada, N6A 5W9
SunnyBrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
University Health Network- Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G2M9
Canada, Quebec
Urology South Shore Research
Greenfield Park, Quebec, Canada, J4V 2H3
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada, H2X 3E4
McGill University Health Centre
Montreal, Quebec, Canada, H4A 3J1
Canada
CHU de Quebec
Quebec, Canada, G1R 2J6
Chile
Fundacion Arturo Lopez Perez
Santiago, Chile, 7500836
Centro de Investigaciones Clinicas Vina del Mar
Santiago, Chile, 7630370
Instituto Clinico Oncologico del Sur (ICOS)
Temuco, Chile, 4810469
Instituto Oncologico Ltda.
Vina del Mar, Chile, 2540364
Centro de Investigaciones Clinicas
Vina del Mar, Chile, 2540488
China, Beijing
Peking University First Hospital
Beijing, Beijing, China, 100034
Beijing Cancer Hospital
Beijing, Beijing, China, 100142
Peking University Third Hospital
Beijing, Beijing, China, 100191
Beijing Hospital
Beijing, Beijing, China, 100730
Peking Union Medical College Hospital
Beijing, Beijing, China, 100730
China, Chongqing
Chongqing Cancer Hospital
Chongqing, Chongqing, China, 400030
China, Guangdong
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 510120
China, Hubei
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China, 430030
China, Jiangsu
Office of Hongqian Guo
Nanjing, Jiangsu, China, 210008
Jiangsu Cancer Hospital
Nanjing, Jiangsu, China, 210009
Jiangsu Province Hospital
Nanjing, Jiangsu, China, 210029
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215004
Wuxi People's Hospital
Wuxi, Jiangsu, China, 214023
China, Shandong
Qingdao Municipal Hospital (East Hospital)
Qingdao, Shandong, China, 266071
China, Shanghai
Fudan University Shanghai Cancer Center
Shanghai, Shanghai, China, 200032
Huashan Hospital Fudan University
Shanghai, Shanghai, China, 200040
Shanghai First People's Hospital
Shanghai, Shanghai, China, 200080
Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai, China, 200092
Shanghai Changhai Hospital
Shanghai, Shanghai, China, 200433
China, Shanxi
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shanxi, China, 710061
China, Zhejiang
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310009
The First Affiliated Hospital of Wenzhou University
Wenzhou, Zhejiang, China, 325000
China
UNIMED Medical Institute Limited
Hong Kong, China
The Second Hospital of Tianjin Medical University
Tianjin, China, 300211
Denmark
Rigshospitalet 7521
Copenhagen, Norrebro, Denmark, 2200
Copenhagen Prostate Cancer Center
Copenhagen, N, Denmark, 2200
Aarhus University Hospital
Arhus N, Denmark, 8200
Rigshospitalet
Copenhagen, Denmark, 2100
Frederiksberg Hospital
Frederiksberg, Denmark, 2000
Herlev Hospital
Herlev, Denmark, 2730
Odense University Hospital
Odense C, Denmark, 5000
Vejle Sygehus
Vejle, Denmark, 7100
Finland
Docrates Syopasairaala
Helsinki, Finland, 00180
Helsingin yliopistollinen keskussairaala, Meilahden sairaala
Helsinki, Finland, 00290
Oulun yliopistollinen sairaala
Oulu, Finland, 90220
Satakunnan keskussairaala
Pori, Finland, 28500
Tampereen yliopistollinen Sairaala
Tampere, Finland, 33520
France
Hopitaux Universitaires de Strasbourg - Hopital Civil
STRASBOURG Cedex, Alsace, France, FR-67091
Centre Paul Strauss
Strasbourg, Bas-rhin, France, 67000
Clinique Sainte Anne
Strasbourg, Bas-rhin, France, 67000
Societe MIM, Clinique Sainte Anne
Strasbourg, Bas-rhin, France, 67000
Institut Curie
Paris Cedex, Paris, France, 75005
Centre Hospitalier Lyon Sud
Pierre Benite Cedex, Rhone, France, 69495
Institut Gustave Roussy
Villejuif Cedex, VAL DE Marne, France, 94805
Institut de Cancerologie de l'Ouest - Paul Papin
Angers Cedex 2, France, 49055
Institut Sainte Catherine
Avignon, Cedex 9, France, 84918
Institut Bergonie
Bordeaux Cedex, France, 33076
Urologic Oncology Department- Institut Bergonie - Centre regional de Lutte contre le Cancer
Bordeaux Cedex, France, 33076
Cabinet de Radiologie
Brest, France, 29200
CHU Brest Hopital Morvan
Brest, France, 29200
Clinique pasteur Lancroze
Brest, France, 29200
Clinique Pasteur-Lanroze
Brest, France, 29200
CHRU de Brest
Brest, France, 29609
Hopital Pasteur
Colmar Cedex, France, 68024
Hopitaux Civils de Colmar
Colmar, France, 68024
Centre Regional de lutte Contre le Cancer Georges Francois Leclerc
Dijon, France, 21000
Clinique Victor Hugo
Le Mans,Cedex, France, 72000
Hopital Calude Huriez - CHU Lille
Lille, France, 59037
Hopital Edouard Herriot - CHU Lyon
Lyon Cedex 03, France, 69437
Centre Leon Berard
Lyon Cedex, France, 69008
Centre de Medecine Nucleaire LUMEN
Lyon, France, 69008
Hopital Nord
Marseille, France, 13915 Cedex 20
ICM Val D'Aurelle
Montpellier Cedex, France, 34298
Hopital Europeen Georges Pompidou
Paris, Cedex 15, France, 75908
Centre Hospitalier Lyon Sud
Pierre Benite, France, 69495
CHU Poitiers - Hopital la Miletrie
Poitiers, Cedex, France, 86021
Institut de Cancerologie de I'Ouest - Rene Gauducheau
Saint-Herblain Cedex, France, 44805
Clinique Pasteur - CIMOF
Toulouse Cedex 3, France, 31076
Clinique Pasteur- Service Imagerie et Radiologie
Toulouse Cedex 3, France, 31076
Clinique Pasteur
Toulouse Cedex 3, France, 31076
IUCT-Oncopole
Toulouse Cedex 9, France, 31059
Institut Claudius Regaud
Toulouse, France, 31059 Cedex 9
Germany
Studienpraxis Urologie
Nuertingen, Baden-wuerttemberg, Germany, 72622
Universitatsmedizin Mannheim, Medizinische Fakultat Mannheim der Universitat Heidelberg
Mannheim, Baden-wurttemberg, Germany, 68167
MVZ Zentrum fuer Diagnostische Radiologie und Nuklearmedizin Braunschweig GmbH
Braunschweig, Niedersachsen, Germany, 38102
Staedtisches Klinikum Braunschweig
Braunschweig, Niedersachsen, Germany, 38126
Hannover Medical School
Hannover, Niedersachsen, Germany, 30625
Medizinische Hochschule Hannover
Hannover, Niedersachsen, Germany, 30625
RWTH University Aachen
Aachen, Nordrhein-westfalen, Germany, 52057
Uniklinik der RWTH Aachen
Aachen, Nordrhein-westfalen, Germany, 52074
Clinic of Radiology
Aachen, Nordrhein-westfalen, Germany, D-52074
Universitaetsklinikum Carl Gustav Carus an der TU Dresden
Dresden, Saxony, Germany, 01307
Charite, Campus Benjamin Franklin
Berlin, Germany, 12200
Charite, Universitaetsmedizin Berlin
Berlin, Germany, 12200
Martini-Klinik am UKE GmbH
Hamburg, Germany, 20246
Diagnostikzentrum Esslingen
Kirchheim, Germany, 73230
Greece
University General Hospital of Heraklion, Urology Clinic
Heraklion, Crete, Greece, 71110
General Hospital of Athens"Korgialeneio-Benakeio EES".Urology Clinic
Athens, Greece, 11526
General Hospital of Athens "Alexandra", Therapeutic Clinic
Athens, Greece, 11528
University General Hospital of Larissa, Urology Department
Larissa, Greece, 41110
University General Hospital of Patras, Oncology Department, Internal Medicine Clinic
Patra, Greece, 26504
General Hospital" Papageorgiou",B' Univ.Urology Clinic
Thessaloniki, Greece, 56429
Hong Kong
Queen Mary Hospital
Hong Kong, Hong Kong
Tuen Mun Hospital
Hong Kong, Hong Kong
Prince of Wales Hospital
Shatin, Hong Kong
Italy
Laboratorio Medicina Nucleare-Ospedale G.B. Morgagni-Pierantoni
Forli, FC, Italy, 47121
Farmacia, Azienda Socio Sanitaria Territoriale di Cremona
Cremona, Italy, 26100
Medicina Nucleare, Azienda Socio Sanitaria Territoriale di Cremona
Cremona, Italy, 26100
Servizio di Radiologia, Azienda Socio Sanitaria Territoriale di Cremona
Cremona, Italy, 26100
Struttura Complessa di Oncologia, Azienda Socio Sanitaria Territoriale di Cremona
Cremona, Italy, 26100
U.O. di Oncologia, Ospedale Civile Degli Infermi
Faenza (RA), Italy, 48018
U.O. di Radiologia, Ospedale Civile degli Infermi
Faenza (RA), Italy, 48018
U.O. di Oncologia, Ospedale Civile Umberto I
Lugo (RA), Italy, 48022
U.O. di Radiologia, Ospedale Civile Umberto I
Lugo (RA), Italy, 48022
Laboratorio Farmaci Antiblastici
Meldola (FC), Italy, 47014
U.O. Oncologia Medica
Meldola (FC), Italy, 47014
UO Radiologia
Meldola (FC), Italy, 47014
Dipartimento di Radiologia, Ospedale San Raffaele
Milano, Italy, 20132
Servizio di Farmacia, Ospedale San Raffaele
Milano, Italy, 20132
U.O. di Medicina Nucleare e Centro PET, Ospedale San Raffaele
Milano, Italy, 20132
U.O. di Urologia, Ospedale San Raffaele
Milano, Italy, 20132
Farmacia Studi Clinici e Sperimentali, Fondazione IRCCS Istituto Nazionale dei Tumori
Milano, Italy, 20133
S.C. di Oncologia Medica 1, Fondazione IRCCS Istituto Nazionale dei Tumori
Milano, Italy, 20133
S.C. Diagnostica Radiologica 2, Fondazione IRCCS Istituto Nazionale dei Tumori
Milano, Italy, 20133
Divisione di Radiologia, Istituto Europeo di Oncologia
Milano, Italy, 20141
Reparto Oncologia Medica Urogenitale e Cervico Facciale, Istituto Europeo di Oncologia
Milano, Italy, 20141
Servizio Farmacia, Istituto Europeo di Oncologia
Milano, Italy, 20141
A. O. U. Policlinico di Modena, U. O. Oncologia
Modena, Italy, 41124
Azienda Ospedaliero-Universitaria Policlinico di Modena
Modena, Italy, 41124
Farmacia Interna, Azienda Ospedaliero-Universitaria Policlinico di Modena
Modena, Italy, 41124
Medicina Nucleare, Azienda Ospedaliero-Universitaria Policlinico di Modena
Modena, Italy, 41124
Radiologia I, Azienda Ospedaliero-Universitaria Policlinico di Modena
Modena, Italy, 41124
U.O.S.C. di Oncologia Medica, A.O.R.N. "A. Cardarelli"
Napoli, Italy, 80131
Farmacia Ospedaliera, AOU San Luigi Gonzaga
Orbassano (TO), Italy, 10043
SCDU Oncologia Medica II Pad, AOU San Luigi Gonzaga
Orbassano (TO), Italy, 10043
SCDU Radiodiagnostica, AOU San Luigi Gonzaga
Orbassano (TO), Italy, 10043
SS Medicina Nucleare, AOU San Luigi Gonzaga
Orbassano (TO), Italy, 10043
Farmacia, Istituto Oncologico Veneto (IOV)
Padova, Italy, 35128
IRCCS - Istituto Oncologico Veneto (IOV), UOC Oncologia Medica 1
Padova, Italy, 35128
Medicina Nucleare, Istituto Oncologico Veneto (IOV)
Padova, Italy, 35128
UOC Radiodiagnostica Oncologica, Istituto Oncologico Veneto (IOV)
Padova, Italy, 35128
Ospedale Santa Maria delle Croci
Ravenna, Italy, 48121
Servizio di Farmacia, AUSL di Ravenna
Ravenna, Italy, 48121
Servizio di Radiologia, AUSL di Ravenna
Ravenna, Italy, 48121
Azienda Ospedaliera S. Camillo Forlanini, UOC per il governo clinico in Oncologia Medica
Roma, Italy, 00152
U.O. di Oncologia Medica, Ospedale Santa Chiara
Trento, Italy, 38122
U.O. Farmacia, Ospedale Santa Chiara
Trento, Italy, 38122
U.O. Radiologia, Ospedale Santa Chiara
Trento, Italy, 38122
Korea, Republic of
National Cancer Center
Goyang-si, Gyeonggi-do, Korea, Republic of, 10408
Chonnam National University Hwasun Hospital
Hwasun-gun, Jeonnam, Korea, Republic of, 58128
Gachon University Gil Medical Center
Incheon, Korea, Republic of, 21565
Seoul National University Hospital
Seoul, Korea, Republic of, 03080
Severance Hospital, Yonsei University Health System
Seoul, Korea, Republic of, 03722
Asan Medical Center
Seoul, Korea, Republic of, 05505
Gangnam Severance Hospital, Yonsei University Health System
Seoul, Korea, Republic of, 06273
Samsung Medical Center
Seoul, Korea, Republic of, 06351
Malaysia
Universiti Kebangsaan Malaysia Medical Centre
Cheras, Kuala Lumpur, Malaysia, 56000
Sarawak General Hospital
Kuching, Sarawak, Malaysia, 93586
Subang Jaya Medical Centre Sdn. Bhd.
Subang Jaya, Selangor Darul Ehsan, Malaysia, 47500
Hospital Kuala Lumpur
Kuala Lumpur, Malaysia, 50586
University Malaya Medical Centre
Kuala Lumpur, Malaysia, 59100
Netherlands
Catharina Ziekenhuis
Eindhoven, Noord-brabant, Netherlands, 5623 EJ
Netherlands Cancer Institute
Amsterdam, Netherlands, 1066 CX
Albert Schweitzer Ziekenhuis
Dordrecht, Netherlands, 3318 AT
University Medical Center Groningen
Groningen, Netherlands, 9700 RB
University Hospital Maastricht (MUMC)
Maastricht, Netherlands, 6229 HX
Radboud University Nijmegen Medical Centre
Nijmegen, Netherlands, 6525 GA
New Zealand
Canterbury Regional Cancer & Blood Service
Christchurch, Canterbury, New Zealand, 8140
Palmerston North Hospital
Palmerston North, Manawatu, New Zealand, 4414
Waikato Urology Research LTD
Hamilton, Waikato, New Zealand, 3204
Regional Blood and Cancer Services
Auckland, New Zealand, 1023
Greenlane Clinical Centre
Auckland, New Zealand, 1051
Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, Poland, 80-952
UROMEDYK, Poradnia Urologiczna
Kielce, Poland, 25-112
Malopolskie Centrum Medyczne s.c.
Krakow, Poland, 30-510
Wojewodzki Szpital Specjalistyczny im. Stefana Kardynala Wyszynskiego SPZOZ
Lublin, Poland, 20-718
Wojewodzki Szpital Specjalistyczny im. Janusza. Korczaka
Slupsk, Poland, 76-200
Profesorskie Centrum Medyczne Optimum
Wroclaw, Poland, 50-421
Centrum Medyczne Melita Medical
Wroclaw, Poland, 50-449
Wro Medica
Wroclaw, Poland, 51-685
Lexmedica
Wroclaw, Poland, 53-114
Russian Federation
Federal State Budgetary Institution "N.N. Blokhin Russian Cancer Research Center"
Moscow, Russian Federation, 115478
P. Hertsen Moscow Oncology Research Institute - branch of the National Medical Research
Moscow, Russian Federation, 125284
State Budgetary Healthcare Institution City Multifield Hospital No.2
Saint-Petersburg, Russian Federation, 194354
SBEI HPE "First Pavlov State Medical University of St. Petersburg" of
Saint-Petersburg, Russian Federation, 197002
SBEI HPE "First Pavlov State Medical University of St. Petersburg" of
Saint-Petersburg, Russian Federation, 197022
Saint-Petersburg State Budgetary Healthcare Institution "Hospital for Veterans of War"
Saint-Petersburg, Russian Federation, 197183
SBHI "Saint-Petersburg clinical scientific
Saint-Petersburg, Russian Federation, 197758
SBEI of HPE "Bashkir State Medical University" of MoH of the RF
Ufa, Russian Federation, 450073
Serbia
Clinical Center Of Serbia, Clinic of Urology
Belgrade, Serbia, 11000
Clinical Center "Dr Dragisa Misovic -Dedinje", Clinic of Urology
Belgrade, Serbia, 11040
Clinical Center "Bezanijska Kosa", Department of Urology
Belgrade, Serbia, 11080
Clinical Center Zemun
Belgrade, Serbia, 11080
Singapore
National University Hospital
Singapore, Singapore, 119074
National Cancer Centre Singapore
Singapore, Singapore, 169610
Slovakia
Fakultna nemocnica s poliklinikou F.D. Roosevelta
Banska Bystrica, Slovakia, 975 17
Institut nuklearnej a molekularnej mediciny
Banska Bystrica, Slovakia, 975 17
Bratislavske radiodiagnosticke centrum, a.s.
Bratislava, Slovakia, 814 99
CUIMED, s.r.o., Urologicka ambulancia
Bratislava, Slovakia, 851 05
Vychodoslovensky onkologicky ustav, a.s.
Kosice, Slovakia, 041 91
Vychodoslovensky onkologicky ustav, a.s.
Kosice, Slovakia, 04191
Institut nuklearnej a molekularnej mediciny
Kosice, Slovakia, 042 53
Univerzitna nemocnica Martin
Martin, Slovakia, 036 59
IZOTOPCENTRUM, s.r.o.
Nitra, Slovakia, 949 01
Jessenius-diagnosticke centrum, a.s.
Nitra, Slovakia, 949 01
UROEXAM spol. s r.o. urologicka ambulancia
Nitra, Slovakia, 949 01
Alfamedis, s.r.o.
Presov, Slovakia, 080 01
MILAB s.r.o., UROCENTRUM
Presov, Slovakia, 080 01
Vivamed, s.r.o
Presov, Slovakia, 080 01
UVN SNP - FN Ruzomberok, Pracovisko Nuklearnej mediciny CCSR
Ruzomberok, Slovakia, 034 26
Fakultna nemocnica s Poliklinikou Skalica a.s
Skalica, Slovakia, 909 82
GAMMALAB, spol. s.r.o., Oddelenie nuklearnej mediciny
Trnava, Slovakia, 917 01
GAMMALAB, spol.s.r.o., Oddelenie nuklearnej mediciny
Trnava, Slovakia, 917 01
KK MED s.r.o.
Zilina, Slovakia, 010 01
Fakultna nemocnica s poliklinikou Zilina, Urologicke oddelenie
Zilina, Slovakia, 012 07
Spain
Hospital Clinico Universitario de Santiago de Compostela
Santiago de Compostela, A Coruna, Spain, 15706
Hospital Universitari Son Espases,
Palma de Mallorca, Baleares, Spain, 07010
Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
ALTAHIA. Xarxa Assistencial Universitaria de Manresa
Manresa, Barcelona, Spain, 08243
Hospital Universitario Parc Tauli
Sabadell, Barcelona, Spain, 08208
ICO Girona-Hospital Universitari de Girona Dr. Josep Trueta
Gerona, Cataluna, Spain, 17007
Hospital de Navarra
Pamplona, Navarra, Spain, 31008
Complejo Hospitalario Universitario A Coruna
A Coruna, Spain, 15006
Hospital Del Mar
Barcelona, Spain, 08003
Cetir Centre Medic, S.L.
Barcelona, Spain, 08029
Hospital Clinic de Barcelona
Barcelona, Spain, 08036
Hospital Universitario de la Princesa
Madrid, Spain, 28006
MD Anderson Cancer Center
Madrid, Spain, 28033
Hospital Universitario 12 de octubre
Madrid, Spain, 28041
Sweden
Urologmottagningen
Goteborg, Sweden, 41345
Diagnostiskt centrum for bild- och funktionsmedicin
Malmo, Sweden, 205 02
Urologiska Kliniken
Malmo, Sweden, 20502
Apoteket AB Kliniska Provningar Molnlycke
Molnlycke, Sweden, 435 33
Karolinska Universitetssjukhuset
Solna, Sweden, 17164
Urologmottagningen
Stockholm, Sweden, 11853
Urologkliniken
Umea, Sweden, 90185
Urologiska Kliniken
Örebro, Sweden, 70185
Taiwan
Chang Gung Medical Fundation, Chiayi Branch(Chiayi Chang Gung Memorial Hospital)
Chiayi County, Taiwan, 613
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung, Taiwan, 807
Kaohsiung Veterans General Hospital
Kaohsiung, Taiwan, 81362
Chang Gung Medical Fundation,Kaohsiung (Kaohsiung Chang Gung Memorial Hospital)
Kaohsiung, Taiwan, 830
Chang Gung Memorial Hospital, Keelung Branch (Keelung Chang Gung Memorial Hospital)
Keelung City, Taiwan, 204
China Medical University Hospital
Taichung, Taiwan, 40447
Taichung Veterans General Hospital
Taichung, Taiwan, 40705
Chi Mei Medical Centre
Tainan City, Taiwan, 710
National Taiwan University Hospital
Taipei, Taiwan, 100
Taipei Veterans General Hospital
Taipei, Taiwan, 11217
Chang-Gung Memorial Hospital at Linkuo
Taoyuan County, Taiwan, 333
Thailand
Maharaj Nakorn Chiang Mai Hospital
Muang, Chiang MAI, Thailand, 50200
Songklanagarind Hospital
Hat Yai, Songkla, Thailand, 90110
King Chulalongkorn Memorial Hospital, Chulalongkorn University
Bangkok, Thailand, 10330
Rajavithi Hospital
Bangkok, Thailand, 10400
Turkey
Cukurova Universitesi Tip Fakultesi
Adana, Turkey, 01330
Hacettepe Universitesi Tip Fakultesi
Ankara, Turkey, 06100
Istanbul Universitesi Cerrahpasa Tip Fakultesi
Istanbul, Turkey, 34098
Izmir Bozyaka Egitim Arastirma Hastanesi
Izmir, Turkey, 35170
Celal Bayar Universitesi Tip Fakultesi
Manisa, Turkey, 45030
Ukraine
RCI Chernivtsi Regional Clinical Hospital
Chernivtsi, Ukraine, 58002
CI Dnipropetrovsk I.I. Mechnykov RCH, Department of Urology #2
Dnipropetrovsk, Ukraine, 49005
CHI V.I.Shapoval RCC of Urology and Nephrology, Dep. Of Urology#4
Kharkiv, Ukraine, 61037
Kyiv City Clinical Hospital #3, Department of Urology
Kyiv, Ukraine, 02125
Central City Clinical Hospital, City Oncological Center
Uzhgorod, Ukraine, 88000
CI Zaporizhzhia Regional Clinical Hospital, Dep. Of Urology,
Zaporizhzhia, Ukraine, 69600
United Kingdom
East and North Hertfordshire NHS Trust
Northwood, Middlesex, United Kingdom, HA6 2RN
Belfast Health and Social Care Trust
Belfast, Northern Ireland, United Kingdom, BT9 7AB
Royal Marsden NHS Foundation Trust
Sutton, Surrey, United Kingdom, SM2 5PT
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE7 7DN
University Hospitals Birmingham NHS Foundation Trust
Birmingham, United Kingdom, B15 2TH
University Hospitals Birmingham NHS Foundation Trust
Birmingham, United Kingdom, B15 2WB
University Hospitals Bristol NHS Foundation Trust
Bristol, United Kingdom, BS2 8ED
University Hospitals Bristol NHS Foundation Trust
Bristol, United Kingdom, BS2 8HW
Cambridge University Hospitals NHS Foundation Trust
Cambridge, United Kingdom, CB2 0QQ
University College Hospitals NHS Trust
London, United Kingdom, NW1 2BU
Imperial College Healthcare NHS Trust
London, United Kingdom, W12 0HS
University College London Hospitals NHS Foundation Trust
London, United Kingdom, WC1E 6AG
The Christie NHS Foundation Trust
Manchester, United Kingdom, M20 4BX
Oxford University Hospitals NHS Trust
Oxford, United Kingdom, OX3 7LE
Sponsors and Collaborators
Pfizer
Astellas Pharma Inc
Medivation LLC, a wholly owned subsidiary of Pfizer Inc.
Investigators
Layout table for investigator information
Study Director: Pfizer Pfizer CT.gov Call Center Pfizer
  Study Documents (Full-Text)

Documents provided by Pfizer:
Study Protocol  [PDF] August 11, 2017
Statistical Analysis Plan  [PDF] August 10, 2017


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02003924     History of Changes
Other Study ID Numbers: MDV3100-14
C3431005 ( Other Identifier: Alias Study Number )
2012-005665-12 ( EudraCT Number )
First Posted: December 6, 2013    Key Record Dates
Results First Posted: July 12, 2018
Last Update Posted: October 3, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases