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Prostate CancerPhase 3NCT00928434

A Study of Degarelix in Patients With Prostate Cancer

A Phase 3 study testing Degarelix and Leuprolide in people with Prostate Cancer, run by Ferring Pharmaceuticals at 59 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Degarelix and Leuprolide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
409 participants
Where
59 sitesUnited States
Study dates
May 2009to Aug 2012
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 12Show fewer
  • 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.

Trial locations and contacts

59 sites in 1 country.

59 sites in 1 country

United States59 sites

  • The Urological Institute of NE NY, CCP

    Albany, New York

  • Alabama Clinical Research, Inc

    Alexander City, Alabama

  • Advanced Urology Medical Center

    Anaheim, California

  • Peninsula Urology Medical Center

    Atherton, California

  • University of Colorado Health Sciences Center

    Aurora, Colorado

  • South Florida Medical Research

    Aventura, Florida

  • Chesapeake Urology Associates

    Baltimore, Maryland

  • Chesapeake Urology Research Associates

    Baltimore, Maryland

  • Medical & Clinical Research Associates

    Bay Shore, New York

  • Brooklyn Heights Urology Associates, P.C.

    Brooklyn, New York

  • Urology Health Solutions, Inc

    Celebration, Florida

  • Northeast Urology Research

    Concord, North Carolina

  • The Urology Center of Colorado

    Denver, Colorado

  • Urology Associates Research

    Englewood, Colorado

  • Urology Associates of Englewood

    Englewood, New Jersey

  • Deaconess Clinic Inc

    Evansville, Indiana

  • Florida Urology Physicians

    Fort Myers, Florida

  • Northeast Indiana Research

    Fort Wayne, Indiana

  • Urology Associates of Central California

    Fresno, California

  • University of Florida

    Gainesville, Florida

  • Chesapeake Urology Research Associates

    Glen Burnie, Maryland

  • Myron Murdock M.D. LLC

    Greenbelt, Maryland

  • Alliance Urology Specialists

    Greensboro, North Carolina

  • Hamilton Urology PA

    Hamilton, New Jersey

  • Urology Center of Alabama, PC

    Homewood, Alabama

  • Metropolitan Urology, PSC

    Jeffersonville, Indiana

  • South Orange County Medical Research Center

    Laguna Hills, California

  • Urological Association of Lancaster

    Lancaster, Pennsylvania

  • Lawrenceville Urology

    Lawrenceville, New Jersey

  • Atlantic Urology Medical Group

    Long Beach, California

  • Urology Enterprises

    Marietta, Georgia

  • Midwest Urology/RMD Clinical Research Institute

    Melrose Park, Illinois

  • Connecticut Clinical Research Center

    Middlebury, Connecticut

  • Carolina Urologic Research Center

    Myrtle Beach, South Carolina

  • Urology Associates

    Nashville, Tennessee

  • Grove Hill Medical Center

    New Britain, Connecticut

  • University Urology Associates

    New York, New York

  • Urology of Virginia

    Norfolk, Virginia

  • Winter Park Urology Associates

    Orlando, Florida

  • Nationsmed Clinical Research

    Perth Amboy, New Jersey

  • Hudson Valley Urology P.C.

    Poughkeepsie, New York

  • Virginal Urology

    Richmond, Virginia

  • Virginia Urology Center

    Richmond, Virginia

  • Lackland Air Force base

    San Antonio, Texas

  • San Bernardino Urological Associates

    San Bernardino, California

  • San Diego Uro-Research

    San Diego, California

  • Santa Barbara Clinical Research

    Santa Barbara, California

  • Seattle Urology Research Center

    Seattle, Washington

  • Regional Urology, Lic

    Shreveport, Louisiana

  • Roger D. Fincher, PS

    Spokane, Washington

  • State College Urologic Association

    State College, Pennsylvania

  • Southeastern Urology Center, PA

    Tallahassee, Florida

  • Tampa Bay Urology

    Tampa, Florida

  • Chesapeake Urology Associates, PA

    Towson, Maryland

  • Advanced Research Institute, Inc

    Trinity, Florida

  • Center for Urologic Care

    Voorhees Township, New Jersey

  • Walter Reed Army Hospital Medical Center

    Washington D.C., District of Columbia

  • Lexington Urological Associates, PA

    West Columbia, South Carolina

  • Delaware Valley Urology LLC

    Woodlane, New Jersey

Other trials in United States

About this study

Official title: 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

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.

Read the 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.

Conditions
Prostate Cancer
Being tested
Degarelix, Leuprolide
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DegarelixDrug

    Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period.

  • DegarelixDrug

    Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses).

  • LeuprolideDrug

    Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each)

Study groups in NCT00928434
Study groupRoleWhat they receive
DI (Degarelix Intermittent)ExperimentalPatients 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.
Receives: Drug: Degarelix
DC (Degarelix Continuous)ExperimentalPatients 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
Receives: Drug: Degarelix
LC (Leuprolide Continuous)Active comparatorPatients 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.
Receives: Drug: Leuprolide

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: At 14 month

Secondary outcomes (19)

  1. Absolute Change From Baseline in Serum PSA Levels

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

    Measured: Phase A Visit 1-8 and Phase B Visit 9-15.

  2. Percent Change From Baseline in Serum PSA Levels

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

    Measured: Phase A Visit 1-8 and Phase B Visit 9-15.

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

    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.

    Measured: During 14 months

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

    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.

    Measured: During 14 months

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

    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.

    Measured: During 14 months

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

    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.

    Measured: During 14 months

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

    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.

    Measured: During 14 months

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

    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.

    Measured: During 14 months

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

    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.

    Measured: During 14 months

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

    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.

    Measured: During 14 months

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

    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.

    Measured: During 14 months

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

    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.

    Measured: During 14 months

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

    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.

    Measured: During 14 months

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

    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.

    Measured: During 14 months

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

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

    Measured: At 14 months

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

    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)

    Measured: During Phase B

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

    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).

    Measured: During Phase B

  18. Absolute Change From Baseline in Serum Testosterone Levels

    Absolute Change From Baseline in Serum Testosterone Levels was measured.

    Measured: Phase A Visit 1-8 and Phase B Visit 9-15.

  19. Percent Change From Baseline in Serum Testosterone Levels

    Percent change from Baseline in serum testosterone levels was measured.

    Measured: Phase A Visit 1-8 and Phase B Visit 9-15.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jun 2009 (estimated)
  2. Study startMay 2009
  3. Primary completionAug 2012
  4. Study completionAug 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
409 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00928434
Sponsor's protocol ID
FE200486 CS37
Status last verified
Oct 2016
First submitted
25 Jun 2009
Last updated
13 Dec 2016
Data monitoring committee
No

Publications

  • Zengerling 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.

    PubMed 34350976

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Degarelix and Leuprolide in people with Prostate Cancer, run by Ferring Pharmaceuticals at 59 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 59 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Dec 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Patients With Serum PSA Levels ≤4.0 ng/mL (time frame: At 14 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00928434, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2016.

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