FIT: Firmagon (Degarelix) Intermittent Therapy
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: 10 month degarelix therapy
|
Drug: degarelix
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.
|
| Active Comparator: 4 month degarelix therapy arm
|
Drug: degarelix
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.
|
Outcome Measures
Primary Outcome Measures
- serum PSA [approximately 15 months]
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
Secondary Outcome Measures
- serum PSA [at 4 months (4 mon arm) or 10 montths (10 mon arm)]
PSA nadir is described as the serum PSA value after the completion of either 4 months or 10 months of therapy.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The Prostate Centre | Vancouver | British Columbia | Canada | V6Z 3J5 |
| 2 | Manitoba Prostate Centre | Winnipeg | Manitoba | Canada | R3E 0V9 |
| 3 | Centre of Clinical Research | Halifax | Nova Scotia | Canada | B3H 1V7 |
| 4 | McMaster Institute of Urology | Hamilton | Ontario | Canada | L8N 4A6 |
| 5 | Centre of Applied Urological Research / Kingston General Hospital | Kingston | Ontario | Canada | K7L 3J7 |
| 6 | London Health Sciences Centre | London | Ontario | Canada | N6A 5W9 |
| 7 | URLX Corporation | Ottawa | Ontario | Canada | K1H 1A2 |
| 8 | Northeast Cancer Centre, Health Sciences North | Sudbury | Ontario | Canada | P3E 5J1 |
| 9 | Sunnybrook Health Sciences Centre | Toronto | Ontario | Canada | M4N 3M5 |
| 10 | University Health Network | Toronto | Ontario | Canada | M5G 2M9 |
| 11 | Recherches Clinique /Clinical Research | Granby | Quebec | Canada | J2G 8Z9 |
| 12 | The Urology Specialists / Les Urologues Specialises | Montreal | Quebec | Canada | H2X 1N8 |
| 13 | MUHC Montreal General Hospital | Montreal | Quebec | Canada | H3G 1A4 |
| 14 | Ultra-Med Research | Pointe Claire | Quebec | Canada | H9R 4S3 |
| 15 | Centre de recherche du CHUQ-L'hotel-Dieu de Quebec | Quebec | Canada | G1R 3S1 |
Sponsors and Collaborators
- Canadian Urology Research Consortium
- Ferring Pharmaceuticals
Investigators
- Principal Investigator: Laurence Klotz, MD, Canadian Urology Research Consortium
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CURC - FIT-0002