A Study of Degarelix in Patients With Prostate Cancer

Ferring Pharmaceuticals409 enrolled

Overview

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.

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

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

409

Conditions

Prostate Cancer

Interventions

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)

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (59)

Outcomes

Primary Outcomes

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.

Time frame: At 14 month

Secondary Outcomes

Absolute Change From Baseline in Serum PSA Levels

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.

Percent Change From Baseline in Serum PSA Levels

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.

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.

Time frame: During 14 months

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.

Data from ClinicalTrials.gov

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Alabama Clinical Research, Inc

Alexander City, Alabama, United States

Urology Center of Alabama, PC

Homewood, Alabama, United States

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Anaheim, California, United States

Peninsula Urology Medical Center

Atherton, California, United States

Urology Associates of Central California

Fresno, California, United States

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Atlantic Urology Medical Group

Long Beach, California, United States

San Bernardino Urological Associates

San Bernardino, California, United States

San Diego Uro-Research

San Diego, California, United States

Santa Barbara Clinical Research

Santa Barbara, California, United States

...and 49 more locations

Time frame: During 14 months

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.

Time frame: During 14 months

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.

Time frame: During 14 months

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.

Time frame: During 14 months

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.

Time frame: During 14 months

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.

Time frame: During 14 months

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.

Time frame: During 14 months

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.

Time frame: During 14 months

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.

Time frame: During 14 months

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.

Time frame: During 14 months

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.

Time frame: During 14 months

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 frame: At 14 months

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 frame: During Phase B

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).

Time frame: During Phase B

Absolute Change From Baseline in Serum Testosterone Levels

Absolute Change From Baseline in Serum Testosterone Levels was measured.

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

Percent Change From Baseline in Serum Testosterone Levels

Percent change from Baseline in serum testosterone levels was measured.

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