Assessment Of Dutasteride (AVODART) In Extending The Time To Progression Of Low-Risk, Localized Prostate Cancer In Men

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00363311
First received: August 11, 2006
Last updated: March 15, 2012
Last verified: June 2011
  Purpose

The purpose of this study is to examine the effect of dutasteride on the inhibition of low-risk, localized prostate cancer progression in men who would otherwise receive no active therapy (expectant management).


Condition Intervention Phase
Neoplasms, Prostate
Prostate Cancer
Drug: Dutasteride
Drug: Matching placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Trial Assessing the Efficacy and Safety of Dutasteride in Extending the Time to Progression of Low-Risk, Localized Prostate Cancer in Men Who Are Candidates for or Undergoing Expectant Management

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of Participants With Prostate Cancer (PCa) Progression [Restricted Crude Rate Analysis: Number of Participants With PCa Divided by Number of Participants in the Intent-to-Treat (ITT) Population Who Had >=1 Post-baseline Biopsy or Had a Progression [ Time Frame: Year 1.5 and Overall (Years 0-3) ] [ Designated as safety issue: No ]
    PC progression (prog.) was defined as the earliest occurrence of primary therapy, also referred to as therapeutic prog., for PC (prostatectomy/radiation/hormonal therapy); or pathological prog., defined as 1 of the following: >=4 cores involved; >=50% of any 1 core involved; or a Gleason pattern of >=4 as a result of any on-study/for-cause biopsy. Primary Gleason grade is assigned to the most common tumor pattern; a second grade to the next most common tumor pattern. The two grades are added together to get a score. Gleason grade= 1-5; Gleason score=2-10; 5 and 10 indicate worst prognosis.


Secondary Outcome Measures:
  • Number of Participants With Therapeutic Progression [ Time Frame: Year 1.5 and Overall (Years 0-3) ] [ Designated as safety issue: No ]
    Primary therapy, also referred to as therapeutic progression, for prostate cancer can be one of the following: prostatectomy, radiation, or hormonal therapy.

  • Number of Participants With Pathologic Progression [ Time Frame: Year 1.5 and Overall (Years 0-3) ] [ Designated as safety issue: No ]
    Pathological progression is defined as one of the following: >=4 cores involved; >=50% of any 1 core involved; or a Gleason pattern of >=4 as a result of any on-study/for-cause biopsy. The 2005 International Society of Urological Pathologists recommendations for Gleason scoring (GS) were used to grade tumors. A primary grade is assigned to the most common tumor pattern, and a second grade to the next most common tumor pattern. The two grades are added together to get a GS. The Gleason grade=1-5, with 5 having the worst prognosis. The Gleason score=2-10, with 10 having the worst prognosis.

  • Participants With at Least One Post-baseline Biopsy With the Indicated Prostate Cancer (PCa) Diagnosis [ Time Frame: Baseline to Month 18 ] [ Designated as safety issue: No ]
    All participants were required by protocol to undergo a transrectal ultrasound (TRUS)-guided 12-core prostate biopsy at 1.5 and 3 years or at the end of the study, if the participant discontinued the study early. Any for-cause biopsy (outside of protocol-mandated biopsies) 12 cores were obtained. If a for-cause biopsy occurred within 6 months prior to the protocol-mandated biopsy, the biopsy was counted as the protocol-mandated biopsy. All biopsies were reviewed and analyzed by a central pathologist.

  • Participants With at Least One Post-baseline Biopsy With the Indicated Prostate Cancer (PCa) Diagnosis for Their Final Biopsy [ Time Frame: Years 0-3 ] [ Designated as safety issue: No ]
    All participants were required by protocol to undergo a TRUS-guided 12-core prostate biopsy at 1.5 and 3 years or at the end of the study, if the participant discontinued the study early. Any for-cause biopsy (outside of protocol-mandated biopsies) 12 cores were obtained. If a for-cause biopsy occurred within 6 months prior to the protocol-mandated biopsy, the biopsy was counted as the protocol-mandated biopsy. The final biopsy is defined as the latest post-baseline biopsy for which the results are available from the central pathology laboratory.

  • Number of Cancer-positive Cores in a 12-core Biopsy [ Time Frame: Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy) ] [ Designated as safety issue: No ]
    All participants were required by protocol to undergo a TRUS-guided 12-core prostate biopsy at 1.5 and 3 years or at the end of the study, if the participant discontinued the study early. Any for-cause biopsy (outside of protocol-mandated biopsies) 12 cores were obtained. All biopsies were reviewed and analyzed by a central pathologist. . The final biopsy is defined as the latest post-baseline biopsy for which the results are available from the central pathology laboratory.

  • Change From Baseline in the Number of Cancer-positive Cores in a 12-core Biopsy at Years 1.5, 3, and 0-3 [ Time Frame: Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy) ] [ Designated as safety issue: No ]
    All participants were required by protocol to undergo a TRUS-guided 12-core prostate biopsy at 1.5 and 3 years or at the end of the study, if the participant discontinued the study early. Any for-cause biopsy (outside of protocol-mandated biopsies) 12 cores were obtained. All biopsies were reviewed and analyzed by a central pathologist. Change from baseline was calculated as the number of cancer-positive cores at post-baseline biopsy minus the number of cancer-positive cores at baseline.

  • Mean Percentage of Cancer-positive Cores in a 12-core Biopsy [ Time Frame: Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy) ] [ Designated as safety issue: No ]
    All participants were required by protocol to undergo a TRUS-guided 12-core prostate biopsy at 1.5 and 3 years or at the end of the study, if the participant discontinued the study early. Any for-cause biopsies (outside of protocol-mandated biopsies) 12 cores were obtained. All biopsies were reviewed and analyzed by a central pathologist. The sum of cancer positive cores and the sum of evaluated cores were used to compute the percentage (100* number of positive cores/number of evaluated cores).

  • Change From Baseline in the Percentage of Cancer-positive Cores in a 12-core Biopsy at Years 1.5, 3, and 0-3 [ Time Frame: Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy) ] [ Designated as safety issue: No ]
    All participants were required by protocol to undergo a TRUS-guided 12-core prostate biopsy at 1.5 and 3 years or at the end of the study, if the participant discontinued the study early. Any for-cause biopsy (outside of protocol-mandated biopsies) 12 cores were obtained. All biopsies were reviewed and analyzed by a central pathologist. (100 * number of positive cores/number of evaluated cores).

  • Cumulative Length of Cancer Tumor Core [ Time Frame: Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy) ] [ Designated as safety issue: No ]
    All participants were required by protocol to undergo a TRUS-guided 12-core prostate biopsy at 1.5 and 3 years or at the end of the study, if the participant discontinued the study early. Any for-cause biopsy (outside of protocol-mandated biopsies) 12 cores were obtained. All biopsies were reviewed and analyzed by a central pathologist. Tumor length is calculated as the number of cores (12) * total tumor length/number of evaluated cores.

  • Change From Baseline in the Cumulative Length of Cancer Tumor Core at Years 1.5, 3, and 0-3 [ Time Frame: Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy) ] [ Designated as safety issue: No ]
    All participants were required by protocol to undergo a TRUS-guided 12-core prostate biopsy at 1.5 and 3 years or at the end of the study, if the participant discontinued the study early. Any for-cause biopsy (outside of protocol-mandated biopsies) 12 cores were obtained. All biopsies were reviewed and analyzed by a central pathologist.

  • Number of Participants With the Indicated Change From Baseline in Gleason Score (GS) on Repeat Biopsy at Year 1.5 [ Time Frame: Year 1.5 ] [ Designated as safety issue: No ]
    The 2005 International Society of Urological Pathologists recommendations for Gleason scoring were used to grade tumors. A primary grade is assigned to the most common tumor pattern (how the cancer cells look under a microscope), and a second grade to the next most common pattern. The two grades are added together to get a GS. Gleason grade range= 1-5; 5=worst prognosis. GS range=2-10; 10=worst prognosis. Improvement is defined as a decrease in GS from a baseline score of 6 (GS<=6; includes no cancer); worsening is defined as an increase in GS from a baseline score of 6 (GS >6).

  • Number of Participants With the Indicated Change From Baseline in Gleason Score on Repeat Biopsy at Years 0-3 [ Time Frame: Years 0-3 (Final Biopsy) ] [ Designated as safety issue: No ]
    The 2005 International Society of Urological Pathologists recommendations for Gleason scoring were used to grade tumors. A primary grade is assigned to the most common tumor pattern (how the cancer cells look under a microscope), and a second grade to the next most common pattern. The two grades are added together to get a GS. Gleason grade range= 1-5; 5=worst prognosis. GS range=2-10; 10=worst prognosis. Improvement is defined as a decrease in GS from a baseline score of 6 (GS<=6; includes no cancer); worsening is defined as an increase in GS from a baseline score of 6 (GS >6).

  • Number of Participants With the Indicated Total Gleason Score [ Time Frame: Years 0-3 (Final Biopsy) ] [ Designated as safety issue: No ]
    All on-study or for-cause biopsies were reviewed and analyzed by a central pathologist. The 2005 International Society of Urological Pathologists recommendations for Gleason scoring were used to grade the tumor. A primary grade is assigned to the most common tumor pattern (how the cancer cells look under a microscope), and a secondary grade to the next most common tumor pattern. The two grades are added together to get a GS. The Gleason grade ranges from 1 to 5, with 5 having the worst prognosis. The Gleason score ranges from 2 to 10, with 10 having the worst prognosis.

  • Number of Biopsies With the Indicated Clinical Tumor Stage at Baseline [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    All on-study or for-cause biopsies were reviewed and analyzed by a central pathologist. The 2005 International Society of Urological Pathologists recommendations for clinical tumor staging were used. T1c = tumor identified by needle biopsy (e.g., because of elevated prostate-specific antigen [PSA]); T2 = tumor confined within the prostate; T2a = tumor involves one-half of one lobe, but not both lobes of the prostate.

  • Number of Post-baseline Biopsies With the Indicated Change From Baseline in Clinical Stage [ Time Frame: Months 0-18 ] [ Designated as safety issue: No ]
    All on-study or for-cause biopsies were reviewed and analyzed by a central pathologist. The National Comprehensive Network (NCCN), 2005 clinical practices guidelines in Oncology-prostate cancer were used for clinical tumor staging. T0: no evidence of primary tumor; T1: clinically inapparent tumor, neither palpable nor visible by imaging; T2: tumor confined within the prostate; T3: tumor extends through the prostate capsule; T4: tumor is fixed or invades adjacent structures other than seminal vesicles. A clinical stage of T0 in post-baseline biopsies has been interpreted as "No Worsening."

  • Prostate Volume (PV) LOCF [ Time Frame: Baseline and Years 1.5 and 3 ] [ Designated as safety issue: No ]

    Prostate volume was determined at baseline, at Year 1.5, and at Year 3. The anteroposterior, cephalocaudal, and transverse diameters of the prostate were obtained by transrectal ultrasound (TRUS) to calculate the prostate volume using the following formula:

    π/ 6 (anteroposterior width * cephalocaudal width * transverse width). Prostate volume calculated by pre-programmed equipment is unacceptable for the on-study prostate volume measurements.


  • Change From Baseline in Prostate Volume at Years 1.5 and 3 [ Time Frame: Baseline and Years 1.5 and 3 ] [ Designated as safety issue: No ]

    Prostate volume was determined at baseline, Year 1.5, and Year 3. The anteroposterior, cephalocaudal, and transverse diameters of the prostate were obtained by transrectal ultrasound (TRUS) to calculate the prostate volume using the following formula:

    π/ 6 (anteroposterior width * cephalocaudal width * transverse width). Prostate volume calculated by pre-programmed equipment was unacceptable for the on-study prostate volume measurements.


  • Percent Change From Baseline in Prostate Volume at Years 1.5 and 3 [ Time Frame: Baseline and Years 1.5 and 3 ] [ Designated as safety issue: No ]

    Prostate volume was determined at baseline, Year 1.5, and Year 3. The anteroposterior, cephalocaudal, and transverse diameters of the prostate were obtained by transrectal ultrasound (TRUS) to calculate the prostate volume using the following formula:

    π/ 6 (anteroposterior width * cephalocaudal width * transverse width). Prostate volume calculated by pre-programmed equipment is unacceptable for the on-study prostate volume measurements.


  • Total Memorial Anxiety Scale Scores for Prostate Cancer (MAX-PC) [ Time Frame: Baseline and Month 3, 6, 12, 18, and 36 ] [ Designated as safety issue: No ]
    The MAX-PC is a self-reported measure evaluating three aspects of PC-related anxiety: general anxiety related to PC/treatment, fear of recurrence, and anxiety related to PSA testing. The MAX-PC consists of 18 questions, each score ranging from 0 (least anxiety) to 3 (maximum anxiety). Total score is the sum of each question score, thus ranging from 0 to 54. A higher MAX-PC score indicates greater anxiety. At Months 18 and 36, participants were given an additional copy of the questionnaire and were asked to complete at home once they were notified of their PSA result and to send back to clinic.

  • Change From Baseline in Total Memorial Anxiety Scale Scores for Prostate Cancer (MAX-PC) LOCF [ Time Frame: Baseline and Months 3, 6, 12, 18, and 36 ] [ Designated as safety issue: No ]
    The MAX-PC is a self-reported measure evaluating three aspects of PC-related anxiety: general anxiety related to PC/treatment, fear of recurrence, and anxiety related to PSA testing. The MAX-PC consists of 18 questions, each score ranging from 0 (least anxiety) to 3 (maximum anxiety). Total score is the sum of each question score, thus ranging from 0 to 54. A higher MAX-PC score indicates greater anxiety. At Months 18 and 36, participants were given an additional copy of the questionnaire and were asked to complete at home once they were notified of their PSA result and to send back to clinic.

  • Total MAX-PC Anxiety Subscale Score Related to PSA Testing [ Time Frame: Baseline and Months 3, 6, 12, 18, and 36 ] [ Designated as safety issue: No ]
    The MAX-PC anxiety subscale consists of 3 questions related to PSA testing; "I have been so anxious about my PSA test that I have thought about delaying it.", "I have been so worried about my PSA test result that I have thought about asking my doctor to repeat the test.", "I have been so concerned about my PSA test result that I have thought about having the test repeated at another laboratory to make sure the test results were accurate." A higher MAX-PC score indicates greater anxiety.Scores range from 0 to 3 for each question. The total score is the sum of the 3 question scores; 0 to 9.

  • Change From Baseline in MAX-PC Anxiety Subscale Score Related to PSA Testing (LOCF) [ Time Frame: Baseline and Months 3, 6, 12, 18, and 36 ] [ Designated as safety issue: No ]
    The MAX-PC anxiety subscale consists of 3 questions related to PSA testing; "I have been so anxious about my PSA test that I have thought about delaying it.", "I have been so worried about my PSA test result that I have thought about asking my doctor to repeat the test.", "I have been so concerned about my PSA test result that I have thought about having the test repeated at another laboratory to make sure the test results were accurate." A higher MAX-PC score indicates greater anxiety.Scores range from 0 to 3 for each question. The total score is the sum of the 3 question scores; 0 to 9.

  • Total MAX-PC Fear of Recurrence Subscale Score [ Time Frame: Baseline and Months 3, 6, 12, 18, and 36 ] [ Designated as safety issue: No ]
    The MAX-PC fear of recurrence subscale consists of 4 questions related to fear of recurrence; "Because cancer is unpredictable, I feel I cannot plan for the future.", "My fear of having my cancer getting worse gets in the way of my enjoying life.", "I am afraid of my cancer getting worse.", "I am more nervous since I was diagnosed with prostate cancer." A higher MAX-PC score indicates greater anxiety. Scores range from 0 to 3 for each question. The total score is the sum of the 4 question scores: 0 to 12.

  • Change From Baseline in MAX-PC Fear of Recurrence Subscale Score (LOCF) [ Time Frame: Baseline and Months 3, 6, 12, 18, and 36 ] [ Designated as safety issue: No ]
    The MAX-PC fear of recurrence subscale consists of 4 questions related to fear of recurrence; "Because cancer is unpredictable, I feel I cannot plan for the future.", "My fear of having my cancer getting worse gets in the way of my enjoying life.", "I am afraid of my cancer getting worse.", "I am more nervous since I was diagnosed with prostate cancer." A higher MAX-PC score indicates greater anxiety. Scores range from 0 to 3 for each question. The total score is the sum of the 4 question scores: 0 to 12.

  • Total Functional Assessment of Cancer Therapy Scale, Prostate Module (FACT-P) Score [ Time Frame: Baseline and Months 18 and 36 ] [ Designated as safety issue: No ]
    The FACT-P consists of a total of 39 questions. This scale is divided into five subscales: the Physical Well-Being Subscale (7 questions); the Social/Family Well-Being Subscale (7 questions); the Emotional Well-Being Subscale (6 questions); the Functional Well-Being Subscale (7 questions); and the Prostate Cancer Subscale (12 questions). The score for each of the 39 questions ranges from 0 to 4. The total FACT-P score thus ranges from 0 to156; a higher score indicates better quality of life.

  • Change From Baseline in Total FACT-P Score (LOCF) [ Time Frame: Baseline and Months 18 and 36 ] [ Designated as safety issue: No ]
    The FACT-P consists of a total of 39 questions. This scale is divided into five subscales: the Physical Well-Being Subscale (7 questions); the Social/Family Well-Being Subscale (7 questions); the Emotional Well-Being Subscale (6 questions); the Functional Well-Being Subscale (7 questions); and the Prostate Cancer Subscale (12 questions). The questionnaire was administered at baseline and at Months 18 and 36. The score for each of the 39 questions ranges from 0 to 4. The total FACT-P score thus ranges from 0 to156; a higher score indicates better QOL.

  • Percent Change From Baseline in Total FACT-P Score (LOCF) [ Time Frame: Baseline and Months 18 and 36 ] [ Designated as safety issue: No ]
    The FACT-P consists of a total of 39 questions. This scale is divided into five subscales: the Physical Well-Being Subscale (7 questions); the Social/Family Well-Being Subscale (7 questions); the Emotional Well-Being Subscale (6 questions); the Functional Well-Being Subscale (7 questions); and the Prostate Cancer Subscale (12 questions). The questionnaire was administered at baseline and at Months 18 and 36. The score for each of the 39 questions ranges from 0 to 4. The total FACT-P score thus ranges from 0 to156; a higher score indicates better QOL.

  • Change From Baseline in FACT-P Physical Well-Being Subscale Score (LOCF) [ Time Frame: Baseline and Months 18 and 36 ] [ Designated as safety issue: No ]
    The FACT-P Physical Well-Being subscale is divided into 7 questions, and the participants rated the outcome over the past 7 days; "I have a lack of energy.", "I have nausea.", "Because of my physical condition, I have trouble meeting the needs of my family.", "I have pain.", "I am bothered by side effects of treatment.", "I feel ill.", "I am forced to spend time in bed." The score for each question ranges from 0 to 4; a lower score indicates better physical well-being. The total FACT-P score thus ranges from 0 to156; a higher score indicates a better quality of life.

  • Change From Baseline in FACT-P Social Well-Being Subscale Score (LOCF) [ Time Frame: Baseline and Months 18 and 36 ] [ Designated as safety issue: No ]
    The FACT-P Social Well-Being subscale is divided into 7 questions, and the participants rated the outcome over the past 7 days; "I feel close to my friends.", "I get emotional support from my family.", "I get support from my friends.", "My family has accepted my illness.", "I am satisfied with family communication about my illness.", "I feel close to my partner (or the person who is my main support).", "I am satisfied with my sex life." The score for each question ranges from 0 to 4; a higher score indicates better social well-being. The total FACT-P score thus ranges from 0 to 156.


Enrollment: 302
Study Start Date: July 2006
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Dutasteride
Dutasteride 0.5mg
Drug: Dutasteride
Dutasteride 0.5mg
Placebo Comparator: Placebo
Matching placebo
Drug: Matching placebo
Matching placebo

  Eligibility

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Must be male ≥48 and ≤82 years of age
  • Have biopsy proven, low-risk, localized prostate cancer and active in expectant management not more than 14 months. [For the purposes of assessing subject eligibility a diagnostic biopsy must have included at least 10 cores, (< 4 cores positive and <50% of any one core positive) and must have been obtained within 8 months of screening]. If a saturation biopsy was performed (20 or more cores obtained) 2-3 cores are to be positive for prostate cancer and with <50% of any one core positive. Initial diagnosis of T1a/T1b obtained during a Transrectal ultrasound (TURP) is not allowed.
  • Gleason score ≤6 [Gleason pattern 4 or above must not be present on any biopsy (initial or entry)]
  • Clinical stage T1c-T2a
  • Serum Prostate Specific Antigen (PSA) ≤11ng/mL. If the screening PSA value from the central laboratory is greater than 11ng/ml, one PSA retest is allowed through the central laboratory
  • A life expectancy greater than five years.
  • Able to swallow and retain oral medication
  • Able and willing to participate in the full 3 years of the study
  • Able to read and write (health outcomes questionnaires are self-administered), understand instructions related to study procedures and give written informed consent.

Exclusion criteria:

  • Subject has ever been treated for prostate cancer with any of the following:
  • Radiotherapy (external beam or brachytherapy)
  • Chemotherapy
  • Hormonal therapy (e.g., megestrol, medroxyprogesterone, cyproterone, diethylstilbestrol (DES)
  • Oral glucocorticoids
  • Gonadotropin-releasing hormone (GnRH) analogues (e.g., leuprolide, goserelin)
  • Glucocorticoids, except inhaled or topical, are not permitted within 3 months prior to visit one
  • Current and/or previous use of the following medications:
  • Finasteride (Proscar, Propecia), or Dutasteride (GI198745, AVODART) exposure within 6 months prior to study entry are excluded.
  • Any other investigational 5α-reductase inhibitors within the past 12 months.
  • Anabolic steroids (subject must discontinued for 6 months prior to study entry to be eligible)
  • Drugs with antiandrogenic properties within the past 6 months (e.g,. spironolactone, flutamide, bicalutamide, *cimetidine, *ketoconazole, metronidazole, progestational agents) NOTE: Use of dietary and herbal supplements (e.g., selenium, Vitamin E, saw palmetto) during the study is discouraged but not prohibited. All dietary and herbal supplement usage will be recorded in the case report form (CRF).

    *The use of cimetidine is permitted prior to study entry. The use of topical ketoconazole is permitted prior to and during the study.

  • Prostate volume >80 cc
  • Subject has had prior prostatic surgery including Transurethral needle ablation of the prostate (TUNA), TURP, Transurethral incision of the prostate (TUIP), laser treatment, thermotherapy, balloon dilatation, prosthesis, and ultrasound ablation within 3 months of enrolment
  • Severe Benign Prostatic Hyperplasia (BPH) symptoms as manifested by International Prostate Symptom Score (IPSS) symptom score (calculated using the first 7 questions only) of ≥25 or >20 if already on alpha blocker therapy.
  • Participation in any investigational or marketed drug trial within the 30 days prior to the first dose of study drug or anytime during the study period.
  • Any unstable serious co-existing medical condition(s) including but not limited to myocardial infarction, coronary bypass surgery, unstable angina, cardiac arrhythmias, clinically evident congestive heart failure, or cerebrovascular accident within 6 months prior to Screening visit; uncontrolled diabetes or peptic ulcer disease which is uncontrolled by medical management.
  • Abnormal liver function test (greater than 2 times the upper limit of normal for alanine aminotransferase [ALT], aspartate aminotransferase [AST], or alkaline phosphatase [ALP]); or bilirubin >1.5 times the upper limit of normal.
  • Serum creatinine >1.5 times the upper limit of normal.
  • History of another malignancy within five years that could affect the diagnosis of prostate cancer.
  • History or current evidence of drug or alcohol abuse within the last 12 months.
  • History of any illness (including psychiatric) that, in the opinion of the investigator, might confound the results of the study or pose additional risk to the subject.
  • Known hypersensitivity to any 5α-reductase inhibitor or to any drug chemically related to dutasteride.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00363311

  Hide Study Locations
Locations
United States, Arkansas
GSK Investigational Site
Little Rock, Arkansas, United States, 72211
United States, California
GSK Investigational Site
Beverly Hills, California, United States, 90210
GSK Investigational Site
Laguna Hills, California, United States, 92653
GSK Investigational Site
Mission Hills, California, United States, 91345
GSK Investigational Site
Modesto, California, United States, 95350
GSK Investigational Site
San Bernardino, California, United States, 92404
GSK Investigational Site
Torrance, California, United States, 90506
United States, Colorado
GSK Investigational Site
Englewood, Colorado, United States, 80113
GSK Investigational Site
Wheat Ridge, Colorado, United States, 80033
United States, Connecticut
GSK Investigational Site
New Britain, Connecticut, United States, 06052
GSK Investigational Site
Trumbull, Connecticut, United States, 06611
United States, District of Columbia
GSK Investigational Site
Washington, District of Columbia, United States, 20307
United States, Florida
GSK Investigational Site
Jacksonville, Florida, United States, 32224
GSK Investigational Site
Largo, Florida, United States, 33773
GSK Investigational Site
Orlando, Florida, United States, 32803
United States, Georgia
GSK Investigational Site
Roswell, Georgia, United States, 30076
United States, Idaho
GSK Investigational Site
Coeur D'alene, Idaho, United States, 83814
United States, Illinois
GSK Investigational Site
Chicago, Illinois, United States, 60612
GSK Investigational Site
Melrose Park, Illinois, United States, 60160
United States, Indiana
GSK Investigational Site
Fort Wayne, Indiana, United States, 46825
GSK Investigational Site
Newburgh, Indiana, United States, 47630
United States, Kansas
GSK Investigational Site
Overland Park, Kansas, United States, 66211
United States, Louisiana
GSK Investigational Site
Shreveport, Louisiana, United States, 71106
United States, Maryland
GSK Investigational Site
Annapolis, Maryland, United States, 21401
GSK Investigational Site
Greenbelt, Maryland, United States, 20770
United States, Massachusetts
GSK Investigational Site
Watertown, Massachusetts, United States, 02472
United States, Minnesota
GSK Investigational Site
Minneapolis, Minnesota, United States
GSK Investigational Site
St. Cloud, Minnesota, United States, 56303
United States, Missouri
GSK Investigational Site
St. Louis, Missouri, United States, 63136
United States, Nevada
GSK Investigational Site
Las Vegas, Nevada, United States, 89148
United States, New Mexico
GSK Investigational Site
Albuquerque, New Mexico, United States, 87109
United States, New York
GSK Investigational Site
Albany, New York, United States, 12208
GSK Investigational Site
Elmont, New York, United States, 11003
GSK Investigational Site
Garden City, New York, United States, 11530
GSK Investigational Site
New York, New York, United States, 10016
GSK Investigational Site
Orchard Park, New York, United States, 14127
GSK Investigational Site
Syracuse, New York, United States, 13210
United States, North Carolina
GSK Investigational Site
Greensboro, North Carolina, United States, 27403
GSK Investigational Site
Salisbury, North Carolina, United States, 28144
GSK Investigational Site
Winston-salem, North Carolina, United States, 27103
United States, Ohio
GSK Investigational Site
Columbus, Ohio, United States, 43214
United States, Oregon
GSK Investigational Site
Springfield, Oregon, United States, 97477
United States, Pennsylvania
GSK Investigational Site
Bala Cynwyd, Pennsylvania, United States, 19004
GSK Investigational Site
Lancaster, Pennsylvania, United States, 17604
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19107
United States, Tennessee
GSK Investigational Site
Memphis, Tennessee, United States, 38119
GSK Investigational Site
Nashville, Tennessee, United States, 37232
United States, Texas
GSK Investigational Site
San Antonio, Texas, United States, 78229
United States, Utah
GSK Investigational Site
Salt Lake City, Utah, United States, 84107
United States, Virginia
GSK Investigational Site
Richmond, Virginia, United States, 23235
GSK Investigational Site
Virginia Beach, Virginia, United States, 23455
GSK Investigational Site
Williamsburg, Virginia, United States, 23185
United States, Washington
GSK Investigational Site
Seattle, Washington, United States, 98101
GSK Investigational Site
Seattle, Washington, United States, 98166
GSK Investigational Site
Spokane, Washington, United States, 99202
Canada, British Columbia
GSK Investigational Site
Surrey, British Columbia, Canada, V3V 1N1
GSK Investigational Site
Victoria, British Columbia, Canada, V8T 5G1
GSK Investigational Site
Victoria, British Columbia, Canada, V8V 3N1
Canada, New Brunswick
GSK Investigational Site
Fredericton, New Brunswick, Canada, E3B 5B8
Canada, Ontario
GSK Investigational Site
Barrie, Ontario, Canada, L4M 7G1
GSK Investigational Site
Brantford, Ontario, Canada, N3R 4N3
GSK Investigational Site
Burlington, Ontario, Canada, L7S 1V2
GSK Investigational Site
Burlington, Ontario, Canada, L7N 3V2
GSK Investigational Site
Guelph, Ontario, Canada, N1H 5J1
GSK Investigational Site
Kitchener, Ontario, Canada, N2N 2B9
GSK Investigational Site
Oakville, Ontario, Canada, L6H 3P1
GSK Investigational Site
Scarborough, Ontario, Canada, M1P 2T7
GSK Investigational Site
Toronto, Ontario, Canada, M6A 3B5
GSK Investigational Site
Toronto, Ontario, Canada, M5G 2M9
GSK Investigational Site
Toronto, Ontario, Canada, M4C 5T2
Canada, Quebec
GSK Investigational Site
Chicoutimi, Quebec, Canada, G7H 4A3
GSK Investigational Site
Greenfield Park, Quebec, Canada, J4V 2H3
GSK Investigational Site
Laval, Quebec, Canada, H7G 2E6
GSK Investigational Site
Montreal, Quebec, Canada, H3G 1A4
GSK Investigational Site
Pointe-claire, Quebec, Canada, H9R 4S3
GSK Investigational Site
Quebec City, Quebec, Canada, G1R 2J6
GSK Investigational Site
Trois Rivieres, Quebec, Canada, G9A 3V7
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00363311     History of Changes
Other Study ID Numbers: AVO105948
Study First Received: August 11, 2006
Results First Received: March 31, 2011
Last Updated: March 15, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Dutasteride Prostate Cancer Expectant management REDEEM

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Dutasteride
5-alpha Reductase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Urological Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 16, 2014