Firmagon (Degarelix) Intermittent Therapy

Study Overview
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Brief Summary
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Men with localized prostate cancer requiring intermittent androgen deprivation therapy for biochemical recurrence following radical therapy will be asked to participate in a phase 4 safety and efficacy clinical trial comparing 10 months versus 4 months of degarelix (Firmagon®) therapy with the endpoint of prolonging the off treatment interval.

Detailed Description
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This is an open-label, multi-centre, randomised trial with subjects receiving subcutaneous (s.c.) monthly injections of degarelix depot. All patients will be treated with a one-month starting dose of 240mg on Day 0. Subjects are then randomized to receive either nine or three maintenance doses of one month duration. The primary objective is to determine the effect of degarelix therapy on the length of the off treatment interval (defined as serum Prostate-specific antigen (PSA) increasing to 5 ng/ml) following completion of the androgen deprivation therapy. The trial will also assess the effect of degarelix therapy on PSA kinetics (specifically PSA doubling time), PSA nadir, and effect on quality of life as well as other measures. The efficacy and safety of these two treatments will also be reported.

Official Title
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Randomized, Multicentre Efficacy and Safety Study Comparing 10 Mons vs 4 Mons Degarelix Therapy in Prolonging the Off Treatment Interval in Men With Localized Prostate Cancer Receiving Intermittent ADT for Biochemical Recurrence Following Radical Local Therapy

Conditions
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Prostate Cancer Recurrent

Intervention / Treatment
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* Drug: degarelix


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: histologically confirmed adenocarcinoma of the prostate for which intermittent endocrine treatment therapy is indicated PSA level meeting both of these criteria: PSA level of ≥ 5 ng/mL. For patients with recurrence after radiotherapy or cryotherapy: Patients should have a serum PSA (two measurements) to be >2 ng/mL higher than a previously confirmed PSA nadir. screening serum testosterone level above the lower limit of normal range defined as >2.2 ng/mL. Exclusion Criteria: Has had previous or is currently under hormonal management of prostate cancer (surgical castration or other hormonal manipulation) Has received therapy with the 5-alpha reductase inhibitors finasteride or dutasteride within 12 weeks and 25 weeks, respectively, prior to screening

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 10 month degarelix therapy<br> | Drug: degarelix<br>* Starting dose of 240 mg (40 mg/mL; injection volume 2 x 3 mL; s.c.) degarelix one-month depot will be administered sc on Day 0, followed by a maintenance dose of 80 mg (20 mg/mL; injection volume 1 x 4 mL; s.c.) sc degarelix one-month depot will be administered into the anterior abdominal wall on Month 1, 2, 3, 4, 5, 6, 7, 8 and 9 for the 10 month arm and month 1, 2 and 3 for the 4 month arm.<br>|
| Active Comparator: 4 month degarelix therapy arm<br> | Drug: degarelix<br>* Starting dose of 240 mg (40 mg/mL; injection volume 2 x 3 mL; s.c.) degarelix one-month depot will be administered sc on Day 0, followed by a maintenance dose of 80 mg (20 mg/mL; injection volume 1 x 4 mL; s.c.) sc degarelix one-month depot will be administered into the anterior abdominal wall on Month 1, 2, 3, 4, 5, 6, 7, 8 and 9 for the 10 month arm and month 1, 2 and 3 for the 4 month arm.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum PSA | The study will compare the length of the off treatment interval (in months) of subjects in the 4 month arm vs those in the 10 month arm. The off treatment interval is defined as the time from PSA nadir following completion of hormone therapy in both arms until the time PSA reaches 5.0ng/ml | approximately 15 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum PSA | PSA nadir is described as the serum PSA value after the completion of either 4 months or 10 months of therapy. | at 4 months (4 mon arm) or 10 montths (10 mon arm) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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localized prostate cancer, degarelix, intermittent androgen deprivation therapy