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Trial · Interventional

CompletedPhase 3Results postedRegistry data

A Study of Degarelix in Patients With Prostate Cancer

NCTNCT00928434 (opens ClinicalTrials.gov in a new tab)Other idFE200486 CS37
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Overview

Status
Completed
Phase
Phase 3
Enrollment
409 participants (actual)
Sponsor
Ferring Pharmaceuticals · Industry
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
May 2009
Primary completion
Aug 2012
Completion
Aug 2012
First posted
26 Jun 2009 (estimated)
Last update posted
13 Dec 2016 (estimated)
Conditions
Prostate Cancer

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20092010201120122013
  1. Ph 3

    A Study of Degarelix in Patients With Prostate Cancer

    NCT00928434

    May 2009 to Aug 2012

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • DegarelixDrug
  • DegarelixDrug
  • LeuprolideDrug

Arms3

  • 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.

  • 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

  • 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.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Percentage of Patients With Serum PSA Levels ≤4.0 ng/mL

    Time frame · At 14 month

    Registry description

    Percentage of patients with serum PSA levels ≤4.0 ng/mL at 14 month was presented.

Secondary outcomes(19)

  1. Absolute Change From Baseline in Serum PSA Levels

    Time frame · Phase A Visit 1-8 and Phase B Visit 9-15.

    Registry description

    Absolute change from Baseline in serum PSA levels during the study period was measured.

  2. Percent Change From Baseline in Serum PSA Levels

    Time frame · Phase A Visit 1-8 and Phase B Visit 9-15.

    Registry description

    Percent change from Baseline in serum PSA levels during the study period was measured.

  3. 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

    Registry description

    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.

  4. Change From Baseline in Quality of Life as Assessed by the FACT-P : Emotional Well-being

    Time frame · During 14 months

    Registry description

    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.

  5. Change From Baseline in Quality of Life as Assessed by the FACT-P : Social Well-being

    Time frame · During 14 months

    Registry description

    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.

  6. Change From Baseline in Quality of Life as Assessed by the FACT-P : Functional Well-being

    Time frame · During 14 months

    Registry description

    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.

  7. Change From Baseline in Quality of Life as Assessed by the FACT-P : Additional Concerns

    Time frame · During 14 months

    Registry description

    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.

  8. Change From Baseline in Quality of Life as Assessed by the FACT-P: Total FACT-P Score

    Time frame · During 14 months

    Registry description

    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.

  9. Change From Baseline in Sexual Function as Assessed by the Sexual Function Index (SFI): Sexual Drive

    Time frame · During 14 months

    Registry description

    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.

  10. Change From Baseline in Sexual Function as Assessed by the SFI: Erection

    Time frame · During 14 months

    Registry description

    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.

  11. Change From Baseline in Sexual Function as Assessed by the SFI: Ejaculation

    Time frame · During 14 months

    Registry description

    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.

  12. Change From Baseline in Sexual Function as Assessed by the SFI: Problem Assessment

    Time frame · During 14 months

    Registry description

    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.

  13. Change From Baseline in Sexual Function as Assessed by the SFI: Overall Satisfaction With Sex Life

    Time frame · During 14 months

    Registry description

    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.

  14. Change From Baseline in Sexual Function as Assessed by the SFI: Total SFI Score

    Time frame · During 14 months

    Registry description

    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.

  15. Percentage of Subjects With a Serum PSA Level ≤4.0 ng/mL

    Time frame · At 14 months

    Registry description

    Percentage of Subjects With a Serum PSA Level ≤4.0 ng/mL was measured during the study period.

  16. Time to Return to Testosterone >0.5 ng/mL Level in the DI Treatment Group

    Time frame · During Phase B

    Registry description

    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)

  17. Time to Return to Normal Range (≥1.5 ng/mL) or Baseline Testosterone Level

    Time frame · During Phase B

    Registry description

    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).

  18. Absolute Change From Baseline in Serum Testosterone Levels

    Time frame · Phase A Visit 1-8 and Phase B Visit 9-15.

    Registry description

    Absolute Change From Baseline in Serum Testosterone Levels was measured.

  19. Percent Change From Baseline in Serum Testosterone Levels

    Time frame · Phase A Visit 1-8 and Phase B Visit 9-15.

    Registry description

    Percent change from Baseline in serum testosterone levels was measured.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· At 14 month

Percentage of Patients With Serum PSA Levels ≤4.0 ng/mL

GroupValue (Percentage of patients)
DI (Degarelix Intermittent)100
Total Continuous98.4
Secondary and other outcome results(7)
Secondary outcomeMean· Phase A Visit 1-8 and Phase B Visit 9-15.

Absolute Change From Baseline in Serum PSA Levels

GroupValue (ng/mL)Spread
DI (Degarelix Intermittent)NANA
DC (Degarelix Continuous)-0.91NA
LC (Leuprolide Continuous)NANA
Secondary outcomeMean· Phase A Visit 1-8 and Phase B Visit 9-15.

Percent Change From Baseline in Serum PSA Levels

GroupValue (Percent change)Spread
DI (Degarelix Intermittent)NANA
DC (Degarelix Continuous)-39.6NA
LC (Leuprolide Continuous)NANA
Secondary outcomeMean· During 14 months

Change From Baseline in Quality of Life as Assessed by the Functional Assessment of Cancer Therapy-Prostate (FACT-P) : Physical Well-being

GroupValue (Scores on a scale)
DI (Degarelix Intermittent)-1.47
DC (Degarelix Continuous)-1.63
LC (Leuprolide Continuous)-1.41
Total Continuous-1.46
Secondary outcomeMean· During 14 months

Change From Baseline in Quality of Life as Assessed by the FACT-P : Emotional Well-being

GroupValue (Scores on a scale)
DI (Degarelix Intermittent)0.69
DC (Degarelix Continuous)1.31
LC (Leuprolide Continuous)0.76
Total Continuous0.88
Secondary outcomeMean· During 14 months

Change From Baseline in Quality of Life as Assessed by the FACT-P : Social Well-being

GroupValue (Scores on a scale)
DI (Degarelix Intermittent)-0.18
DC (Degarelix Continuous)-0.06
LC (Leuprolide Continuous)-0.36
Total Continuous-0.30
Secondary outcomeMean· During 14 months

Change From Baseline in Quality of Life as Assessed by the FACT-P : Functional Well-being

GroupValue (Scores on a scale)
DI (Degarelix Intermittent)-0.96
DC (Degarelix Continuous)-0.88
LC (Leuprolide Continuous)-0.29
Total Continuous-0.42
Secondary outcomeMean· During 14 months

Change From Baseline in Quality of Life as Assessed by the FACT-P : Additional Concerns

GroupValue (Scores on a scale)
DI (Degarelix Intermittent)-1.14
DC (Degarelix Continuous)-0.92
LC (Leuprolide Continuous)-0.51
Total Continuous-0.60

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
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 (Visit 1) 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 (Visit 2 through 7), administered s.c. into the anterior abdominal wall. 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. Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period.–26 / 175159 / 175
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. Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses).–6 / 5047 / 50
LC (Leuprolide Continuous)Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), 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. into a large muscle, according to the directions for use in the manufacturer's labeling 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. Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each).–18 / 178158 / 178

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedZengerling F, Jakob JJ, Schmidt S, Meerpohl JJ, Blumle A, Schmucker C, Mayer B, Kunath F. Degarelix for treating advanced hormone-sensitive prostate cancer. Cochrane Database Syst Rev. 2021 Aug 5;8(8):CD012548. doi: 10.1002/14651858.CD012548.pub2. PMID 34350976

Eligibility

Who could join, as posted.

Sex
Male
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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