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A Study of Degarelix in Patients With Prostate Cancer

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ClinicalTrials.gov Identifier: NCT00928434
Recruitment Status : Completed
First Posted : June 26, 2009
Results First Posted : December 13, 2016
Last Update Posted : December 13, 2016
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE June 25, 2009
First Posted Date  ICMJE June 26, 2009
Results First Submitted Date  ICMJE May 9, 2016
Results First Posted Date  ICMJE December 13, 2016
Last Update Posted Date December 13, 2016
Study Start Date  ICMJE May 2009
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 21, 2016)
Percentage of Patients With Serum PSA Levels ≤4.0 ng/mL [ Time Frame: At 14 month ]
Percentage of patients with serum PSA levels ≤4.0 ng/mL at 14 month was presented.
Original Primary Outcome Measures  ICMJE
 (submitted: June 25, 2009)
PSA [ Time Frame: Monthly ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 21, 2016)
  • Absolute Change From Baseline in Serum PSA Levels [ Time Frame: Phase A Visit 1-8 and Phase B Visit 9-15. ]
    Absolute change from Baseline in serum PSA levels during the study period was measured.
  • Percent Change From Baseline in Serum PSA Levels [ Time Frame: Phase A Visit 1-8 and Phase B Visit 9-15. ]
    Percent change from Baseline in serum PSA levels during the study period was measured.
  • Change From Baseline in Quality of Life as Assessed by the Functional Assessment of Cancer Therapy-Prostate (FACT-P) : Physical Well-being [ Time Frame: During 14 months ]
    The FACT-P is a multidimensional, self-report quality of life (QoL) instrument specifically designed for use with prostate cancer patients. It consists of 27 core items which assess patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being, which is further supplemented by 12 site specific items to assess for prostate related symptoms. Each question is rated on a scale from 0 to 4, and then combined to produce sub-scale scores for each domain, as well as a global QoL score. Physical well-being consist of 7 items and scored on a scale of 0-4 (0=Not at all; 1=A little bit; 2=Somewhat; 3=Quite a bit; 4=Very much). Total score for the physical well-being sub scale ranges from 0 to 28. Higher scores represent better QoL.
  • Change From Baseline in Quality of Life as Assessed by the FACT-P : Emotional Well-being [ Time Frame: During 14 months ]
    The FACT-P is a multidimensional, self-report quality of life (QoL) instrument specifically designed for use with prostate cancer patients. It consists of 27 core items which assess patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being, which is further supplemented by 12 site specific items to assess for prostate related symptoms. Each question is rated on a scale from 0 to 4, and then combined to produce sub-scale scores for each domain, as well as a global QoL score. Emotional well-being consist of 6 items and scored on a scale of 0-4 (0=Not at all; 1=A little bit; 2=Somewhat; 3=Quite a bit; 4=Very much). Total score for the emotional well-being sub scale ranges from 0 to 24. Higher scores represent better QoL.Higher scores represent better QoL.
  • Change From Baseline in Quality of Life as Assessed by the FACT-P : Social Well-being [ Time Frame: During 14 months ]
    The FACT-P is a multidimensional, self-report quality of life (QoL) instrument specifically designed for use with prostate cancer patients. It consists of 27 core items which assess patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being, which is further supplemented by 12 site specific items to assess for prostate related symptoms. Each question is rated on a scale from 0 to 4, and then combined to produce sub-scale scores for each domain, as well as a global QoL score. Social well-being consist of 7 items and scored on a scale of 0-4 (0=Not at all; 1=A little bit; 2=Somewhat; 3=Quite a bit; 4=Very much). Total score for the social well-being sub scale ranges from 0 to 28. Higher scores represent better QoL.
  • Change From Baseline in Quality of Life as Assessed by the FACT-P : Functional Well-being [ Time Frame: During 14 months ]
    The FACT-P is a multidimensional, self-report quality of life (QoL) instrument specifically designed for use with prostate cancer patients. It consists of 27 core items which assess patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being, which is further supplemented by 12 site specific items to assess for prostate related symptoms. Each question is rated on a scale from 0 to 4, and then combined to produce sub-scale scores for each domain, as well as a global QoL score. Functional well-being consist of 7 items and scored on a scale of 0-4 (0=Not at all; 1=A little bit; 2=Somewhat; 3=Quite a bit; 4=Very much). Total score for the functional well-being sub scale ranges from 0 to 28. Higher scores represent better QoL.
  • Change From Baseline in Quality of Life as Assessed by the FACT-P : Additional Concerns [ Time Frame: During 14 months ]
    The FACT-P is a multidimensional, self-report quality of life (QoL) instrument specifically designed for use with prostate cancer patients. It consists of 27 core items which assess patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being, which is further supplemented by 12 site specific items to assess for prostate related symptoms. Each question is rated on a scale from 0 to 4, and then combined to produce sub-scale scores for each domain, as well as a global QoL score. Additional concerns consist of 12 items and scored on a scale of 0-4 (0=Not at all; 1=A little bit; 2=Somewhat; 3=Quite a bit; 4=Very much). Total score for the additional concerns ranges from 0 to 48. Higher scores represent better QoL.
  • Change From Baseline in Quality of Life as Assessed by the FACT-P: Total FACT-P Score [ Time Frame: During 14 months ]
    The FACT-P is a multidimensional, self-report quality of life (QoL) instrument specifically designed for use with prostate cancer patients. It consists of 27 core items which assess patient function in four domains: Physical, Social/Family, Emotional, and Functional well-being, which is further supplemented by 12 site specific items to assess for prostate related symptoms. Each question is rated on a scale from 0 to 4, and then combined to produce sub-scale scores for each domain, as well as a global QoL score. Total FACT-P scores ranges from 0 to 156. Higher scores represent better QoL.
  • Change From Baseline in Sexual Function as Assessed by the Sexual Function Index (SFI): Sexual Drive [ Time Frame: During 14 months ]
    The SFI is a multidimensional, self-report instrument specifically designed to evaluate sexual function and satisfaction of men on treatment or with conditions that may affect sexual function. It consists of 11 questions which assess patient function in four domains: Sexual drive, Erection, Ejaculation, and Problem assessment, and a question in regards to overall assessment of sexual function. Sexual drive domain consist of 2 questions and are scored on a scale of 0-4 (0=minimum, 4=maximum). Total score for the sexual drive domain ranges from 0 to 8. A higher scores represent better sexual function.
  • Change From Baseline in Sexual Function as Assessed by the SFI: Erection [ Time Frame: During 14 months ]
    The SFI is a multidimensional, self-report instrument specifically designed to evaluate sexual function and satisfaction of men on treatment or with conditions that may affect sexual function. It consists of 11 questions which assess patient function in four domains: Sexual drive, Erection, Ejaculation, and Problem assessment, and a question in regards to overall assessment of sexual function. Erection domain consist of 3 questions and are scored on a scale of 0-4 (0=minimum, 4=maximum). Total score for the erection domain ranges from 0 to 12. A higher scores represent better sexual function.
  • Change From Baseline in Sexual Function as Assessed by the SFI: Ejaculation [ Time Frame: During 14 months ]
    The SFI is a multidimensional, self-report instrument specifically designed to evaluate sexual function and satisfaction of men on treatment or with conditions that may affect sexual function. It consists of 11 questions which assess patient function in four domains: Sexual drive, Erection, Ejaculation, and Problem assessment, and a question in regards to overall assessment of sexual function. Ejaculation domain consist of 2 questions and are scored on a scale of 0-4 (0=minimum, 4=maximum). Total score for the ejaculation domain ranges from 0 to 8. A higher scores represent better sexual function.
  • Change From Baseline in Sexual Function as Assessed by the SFI: Problem Assessment [ Time Frame: During 14 months ]
    The SFI is a multidimensional, self-report instrument specifically designed to evaluate sexual function and satisfaction of men on treatment or with conditions that may affect sexual function. It consists of 11 questions which assess patient function in four domains: Sexual drive, Erection, Ejaculation, and Problem assessment, and a question in regards to overall assessment of sexual function. Problem assessment domain consist of 2 questions and are scored on a scale of 0-4 (0=minimum, 4=maximum). Total score for the problem assessment domain ranges from 0 to 8. A higher scores represent better sexual function.
  • Change From Baseline in Sexual Function as Assessed by the SFI: Overall Satisfaction With Sex Life [ Time Frame: During 14 months ]
    The SFI is a multidimensional, self-report instrument specifically designed to evaluate sexual function and satisfaction of men on treatment or with conditions that may affect sexual function. It consists of 11 questions which assess patient function in four domains: Sexual drive, Erection, Ejaculation, and Problem assessment, and a question in regards to overall assessment of sexual function. Overall satisfaction domain consist of single question and is scored on a scale of 0-4 (0=minimum, 4=maximum). A higher score represent better sexual function.
  • Change From Baseline in Sexual Function as Assessed by the SFI: Total SFI Score [ Time Frame: During 14 months ]
    The SFI is a multidimensional, self-report instrument specifically designed to evaluate sexual function and satisfaction of men on treatment or with conditions that may affect sexual function. It consists of 11 questions which assess patient function in four domains: Sexual drive, Erection, Ejaculation, and Problem assessment, and a question in regards to overall assessment of sexual function. Total SFI score ranges from 0 to 44. A higher scores represent better sexual function.
  • Percentage of Subjects With a Serum PSA Level ≤4.0 ng/mL [ Time Frame: At 14 months ]
    Percentage of Subjects With a Serum PSA Level ≤4.0 ng/mL was measured during the study period.
  • Time to Return to Testosterone >0.5 ng/mL Level in the DI Treatment Group [ Time Frame: During Phase B ]
    The time to testosterone >0.5 ng/mL level in the DI group was counted from the start of Phase B at Day 196 (i.e. 28 days after last injection of degarelix)
  • Time to Return to Normal Range (≥1.5 ng/mL) or Baseline Testosterone Level [ Time Frame: During Phase B ]
    The time to return to normal range (≥1.5 ng/mL) or Baseline testosterone level in the DI group was counted from the start of Phase B at Day 196 (i.e. 28 days after last injection of degarelix).
  • Absolute Change From Baseline in Serum Testosterone Levels [ Time Frame: Phase A Visit 1-8 and Phase B Visit 9-15. ]
    Absolute Change From Baseline in Serum Testosterone Levels was measured.
  • Percent Change From Baseline in Serum Testosterone Levels [ Time Frame: Phase A Visit 1-8 and Phase B Visit 9-15. ]
    Percent change from Baseline in serum testosterone levels was measured.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 25, 2009)
  • 1. Reported Outcome Quality of Life intermittent treatment & continuous treatment [ Time Frame: Phase A Visit 1-7. Phase B Visit 8-15. ]
  • 2. PSA [ Time Frame: Monthly ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Degarelix in Patients With Prostate Cancer
Official Title  ICMJE A Randomized, Controlled, Open-Label Study Investigating the Safety and Efficacy of Degarelix Given Intermittently vs Continuous Androgen Deprivation Therapy With Lupron or Degarelix in Patients With Prostate Cancer With Prior Treatment Failure After Localized Treatment
Brief Summary The purpose of this study was to see if giving Degarelix every month for 7 months then stop treatment for 7 months (intermittent therapy) would show a reduction of negative effects of androgen deprivation therapy by increasing the quality of life while keeping prostate specific antigen (PSA) levels suppressed.
Detailed Description

This was an open-label, randomized, parallel-arm, multicenter study to determine if degarelix intermittent therapy was non-inferior to continuous androgen deprivation therapy (combination of treatment groups receiving continuous degarelix and leuprolide therapy, respectively) in maintaining PSA levels at ≤ 4.0 ng/mL at 14 months.

The study consisted of two phases, Phase A and B. During Phase A, patients in the degarelix intermittent and degarelix continuous arms received 7 months of therapy with degarelix one-month depot formulation and patients in the leuprolide continuous arm received leuprolide one-month depot injection (7.5 mg) followed by two 3-month depot (22.5 mg) injections. After 7 months of treatment, patients with a PSA ≤2 ng/mL continued into Phase B.

During Phase B, patients in the degarelix intermittent arm had a 7-month off-treatment period. Patients randomized to the degarelix continuous arm and the leuprolide continuous arm continued to receive degarelix or leuprolide depot as in Phase A for the remainder of the 14 months.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE
  • Drug: Degarelix
    Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period.
  • Drug: Degarelix
    Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses).
  • Drug: Leuprolide
    Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each)
Study Arms  ICMJE
  • Experimental: DI (Degarelix Intermittent)

    Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.

    Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 were administered.

    During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.

    Intervention: Drug: Degarelix
  • Experimental: DC (Degarelix Continuous)

    Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.

    Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall

    Intervention: Drug: Degarelix
  • Active Comparator: LC (Leuprolide Continuous)

    Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0, administered intramuscular (i.m.) into a large muscle, as per manufacturer's labeling directions.

    One injection of 22.5 mg leuprolide 3-month depot was administered i.m. as per manufacturer's labeling directions at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).

    On Investigator's discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.

    Intervention: Drug: Leuprolide
Publications * Zengerling F, Jakob JJ, Schmidt S, Meerpohl JJ, Blümle A, Schmucker C, Mayer B, Kunath F. Degarelix for treating advanced hormone-sensitive prostate cancer. Cochrane Database Syst Rev. 2021 Aug 5;8:CD012548. doi: 10.1002/14651858.CD012548.pub2. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 21, 2016)
409
Original Estimated Enrollment  ICMJE
 (submitted: June 25, 2009)
400
Actual Study Completion Date  ICMJE August 2012
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 18 years or older.
  • Raising PSA after prior treatment failure of localized prostate cancer.
  • Has a histological confirmed non-metastatic cancer of the prostate (Gleason graded) based on the most current biopsy.
  • Has a screening testosterone within normal range (≥1.5 ng/mL).
  • Has Eastern Cooperative Oncology Group score of ≤2.
  • Bone scan or CT scan report documenting no evidence of metastasis to the bone or internal organs.
  • Life expectancy of at least 15 months.

Exclusion Criteria:

  • Taken hormone therapy in the last 6 months prior to entering this study.
  • Being treated with 5-alpha reductase inhibitor at time of enrolment and remained on a stable dose throughout the trial.
  • Has a history of severe uncontrolled asthma, anaphylactic reactions, or severe urticaria and/or angioedema.
  • Has hypersensitivity towards any component of the study drug.
  • Has a previous history or presence of another malignancy other than prostate cancer or treated squamous/basal cell carcinoma of the skin within the last five years.
  • Has abnormal laboratory results which in the judgement of the Investigator would affect the patient's health or the outcome of the trial.
  • Has a clinically significant medical condition (other than prostate cancer) including but not limited to; renal, haematological, gastrointestinal, endocrine, cardiac, neurological or psychiatric disease and alcohol or drug abuse or any other condition which may affect the patient's health or the outcome of the trial as judged by the Investigator.
  • Has an intellectual incapacity or language barriers precluding adequate understanding or co-operation.
  • Has received an investigational drug within the last 28 days before the Screening visit or longer if considered to possibly influence the outcome of the current trial.
  • Has received ketoconazole or diflucan in the last 28 days preceding the Screening Visit.
  • Has previously participated in any Degarelix trial.
  • Is part of an ongoing trial.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00928434
Other Study ID Numbers  ICMJE FE200486 CS37
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ferring Pharmaceuticals
Study Sponsor  ICMJE Ferring Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Development Support Ferring Pharmaceuticals
PRS Account Ferring Pharmaceuticals
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP