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A Study of Degarelix in Patients With Prostate Cancer

Primary Purpose

Prostate Cancer

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Degarelix

Leuprolide

About this trial

This is an interventional treatment trial for Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

DI (Degarelix Intermittent)

DC (Degarelix Continuous)

LC (Leuprolide Continuous)

Arm Description

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.

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Absolute Change From Baseline in Serum PSA Levels

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

Percent Change From Baseline in Serum PSA Levels

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Absolute Change From Baseline in Serum Testosterone Levels was measured.

Percent Change From Baseline in Serum Testosterone Levels

Percent change from Baseline in serum testosterone levels was measured.

Full Information

NCT ID

NCT00928434

First Posted

June 25, 2009

Last Updated

October 21, 2016

Sponsor

Ferring Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00928434

Brief Title

A Study of Degarelix in Patients With Prostate Cancer

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Completed

Study Start Date

May 2009 (undefined)

Primary Completion Date

August 2012 (Actual)

Study Completion Date

August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ferring Pharmaceuticals

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

409 (Actual)

8. Arms, Groups, and Interventions

Arm Title

DI (Degarelix Intermittent)

Arm Type

Experimental

Arm Description

Arm Title

DC (Degarelix Continuous)

Arm Type

Experimental

Arm Description

Arm Title

LC (Leuprolide Continuous)

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Degarelix

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Degarelix

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Leuprolide

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

At 14 month

Secondary Outcome Measure Information:

Title

Absolute Change From Baseline in Serum PSA Levels

Description

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

Time Frame

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

Title

Percent Change From Baseline in Serum PSA Levels

Description

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

Time Frame

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

Title

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

Description

Time Frame

During 14 months

Title

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

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.

Time Frame

During 14 months

Title

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

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.

Time Frame

During 14 months

Title

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

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.

Time Frame

During 14 months

Title

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

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.

Time Frame

During 14 months

Title

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

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.

Time Frame

During 14 months

Title

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

Description

Time Frame

During 14 months

Title

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

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.

Time Frame

During 14 months

Title

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

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.

Time Frame

During 14 months

Title

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

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.

Time Frame

During 14 months

Title

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

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.

Time Frame

During 14 months

Title

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

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.

Time Frame

During 14 months

Title

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

Description

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

Time Frame

At 14 months

Title

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

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)

Time Frame

During Phase B

Title

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

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).

Time Frame

During Phase B

Title

Absolute Change From Baseline in Serum Testosterone Levels

Description

Absolute Change From Baseline in Serum Testosterone Levels was measured.

Time Frame

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

Title

Percent Change From Baseline in Serum Testosterone Levels

Description

Percent change from Baseline in serum testosterone levels was measured.

Time Frame

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

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Development Support

Organizational Affiliation

Ferring Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Alabama Clinical Research, Inc

City

Alexander City

State/Province

Alabama

Country

United States

Facility Name

Urology Center of Alabama, PC

City

Homewood

State/Province

Alabama

Country

United States

Facility Name

Advanced Urology Medical Center

City

Anaheim

State/Province

California

Country

United States

Facility Name

Peninsula Urology Medical Center

City

Atherton

State/Province

California

Country

United States

Facility Name

Urology Associates of Central California

City

Fresno

State/Province

California

Country

United States

Facility Name

South Orange County Medical Research Center

City

Laguna Hills

State/Province

California

Country

United States

Facility Name

Atlantic Urology Medical Group

City

Long Beach

State/Province

California

Country

United States

Facility Name

San Bernardino Urological Associates

City

San Bernardino

State/Province

California

Country

United States

Facility Name

San Diego Uro-Research

City

San Diego

State/Province

California

Country

United States

Facility Name

Santa Barbara Clinical Research

City

Santa Barbara

State/Province

California

Country

United States

Facility Name

University of Colorado Health Sciences Center

City

Aurora

State/Province

Colorado

Country

United States

Facility Name

The Urology Center of Colorado

City

Denver

State/Province

Colorado

Country

United States

Facility Name

Urology Associates Research

City

Englewood

State/Province

Colorado

Country

United States

Facility Name

Connecticut Clinical Research Center

City

Middlebury

State/Province

Connecticut

Country

United States

Facility Name

Grove Hill Medical Center

City

New Britain

State/Province

Connecticut

Country

United States

Facility Name

Walter Reed Army Hospital Medical Center

City

Washington

State/Province

District of Columbia

Country

United States

Facility Name

South Florida Medical Research

City

Aventura

State/Province

Florida

Country

United States

Facility Name

Urology Health Solutions, Inc

City

Celebration

State/Province

Florida

Country

United States

Facility Name

Florida Urology Physicians

City

Fort Myers

State/Province

Florida

Country

United States

Facility Name

University of Florida

City

Gainesville

State/Province

Florida

Country

United States

Facility Name

Winter Park Urology Associates

City

Orlando

State/Province

Florida

Country

United States

Facility Name

Southeastern Urology Center, PA

City

Tallahassee

State/Province

Florida

Country

United States

Facility Name

Tampa Bay Urology

City

Tampa

State/Province

Florida

Country

United States

Facility Name

Advanced Research Institute, Inc

City

Trinity

State/Province

Florida

Country

United States

Facility Name

Urology Enterprises

City

Marietta

State/Province

Georgia

Country

United States

Facility Name

Midwest Urology/RMD Clinical Research Institute

City

Melrose Park

State/Province

Illinois

Country

United States

Facility Name

Deaconess Clinic Inc

City

Evansville

State/Province

Indiana

Country

United States

Facility Name

Northeast Indiana Research

City

Fort Wayne

State/Province

Indiana

Country

United States

Facility Name

Metropolitan Urology, PSC

City

Jeffersonville

State/Province

Indiana

Country

United States

Facility Name

Regional Urology, Lic

City

Shreveport

State/Province

Louisiana

Country

United States

Facility Name

Chesapeake Urology Associates

City

Baltimore

State/Province

Maryland

Country

United States

Facility Name

Chesapeake Urology Research Associates

City

Baltimore

State/Province

Maryland

Country

United States

Facility Name

Chesapeake Urology Research Associates

City

Glen Burnie

State/Province

Maryland

Country

United States

Facility Name

Myron Murdock M.D. LLC

City

Greenbelt

State/Province

Maryland

Country

United States

Facility Name

Chesapeake Urology Associates, PA

City

Towson

State/Province

Maryland

Country

United States

Facility Name

Urology Associates of Englewood

City

Englewood

State/Province

New Jersey

Country

United States

Facility Name

Hamilton Urology PA

City

Hamilton

State/Province

New Jersey

Country

United States

Facility Name

Lawrenceville Urology

City

Lawrenceville

State/Province

New Jersey

Country

United States

Facility Name

Nationsmed Clinical Research

City

Perth Amboy

State/Province

New Jersey

Country

United States

Facility Name

Center for Urologic Care

City

Voorhees

State/Province

New Jersey

Country

United States

Facility Name

Delaware Valley Urology LLC

City

Westampton

State/Province

New Jersey

Country

United States

Facility Name

The Urological Institute of NE NY, CCP

City

Albany

State/Province

New York

Country

United States

Facility Name

Medical & Clinical Research Associates

City

Bay Shore

State/Province

New York

Country

United States

Facility Name

Brooklyn Heights Urology Associates, P.C.

City

Brooklyn

State/Province

New York

Country

United States

Facility Name

University Urology Associates

City

New York

State/Province

New York

Country

United States

Facility Name

Hudson Valley Urology P.C.

City

Poughkeepsie

State/Province

New York

Country

United States

Facility Name

Northeast Urology Research

City

Concord

State/Province

North Carolina

Country

United States

Facility Name

Alliance Urology Specialists

City

Greensboro

State/Province

North Carolina

Country

United States

Facility Name

Urological Association of Lancaster

City

Lancaster

State/Province

Pennsylvania

Country

United States

Facility Name

State College Urologic Association

City

State College

State/Province

Pennsylvania

Country

United States

Facility Name

Carolina Urologic Research Center

City

Myrtle Beach

State/Province

South Carolina

Country

United States

Facility Name

Lexington Urological Associates, PA

City

West Columbia

State/Province

South Carolina

Country

United States

Facility Name

Urology Associates

City

Nashville

State/Province

Tennessee

Country

United States

Facility Name

Lackland Air Force base

City

San Antonio

State/Province

Texas

Country

United States

Facility Name

Urology of Virginia

City

Norfolk

State/Province

Virginia

Country

United States

Facility Name

Virginal Urology

City

Richmond

State/Province

Virginia

Country

United States

Facility Name

Virginia Urology Center

City

Richmond

State/Province

Virginia

Country

United States

Facility Name

Seattle Urology Research Center

City

Seattle

State/Province

Washington

Country

United States

Facility Name

Roger D. Fincher, PS

City

Spokane

State/Province

Washington

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

34350976

Citation

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.

Results Reference

derived

Learn more about this trial

A Study of Degarelix in Patients With Prostate Cancer

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A Study of Degarelix in Patients With Prostate Cancer

Prostate Cancer

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial