Firmagon (Degarelix) Intermittent Therapy

NCT ID: NCT01512472

Last Updated: 2019-09-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 144 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2018-01-31

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.

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.

Conditions

Prostate Cancer Recurrent

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

10 month degarelix therapy

Group Type: ACTIVE_COMPARATOR

degarelix

Intervention Type: DRUG

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.

4 month degarelix therapy arm

Group Type: ACTIVE_COMPARATOR

degarelix

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Ferring Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Canadian Urology Research Consortium

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laurence Klotz, MD

Role: PRINCIPAL_INVESTIGATOR

Canadian Urology Research Consortium

Locations

The Prostate Centre

Vancouver, British Columbia, Canada

Manitoba Prostate Centre

Winnipeg, Manitoba, Canada

Centre of Clinical Research

Halifax, Nova Scotia, Canada

Northeast Cancer Centre, Health Sciences North

Greater Sudbury, Ontario, Canada

McMaster Institute of Urology

Hamilton, Ontario, Canada

Centre of Applied Urological Research / Kingston General Hospital

Kingston, Ontario, Canada

London Health Sciences Centre

London, Ontario, Canada

URLX Corporation

Ottawa, Ontario, Canada

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

University Health Network

Toronto, Ontario, Canada

Recherches Clinique /Clinical Research

Granby, Quebec, Canada

The Urology Specialists / Les Urologues Specialises

Montreal, Quebec, Canada

MUHC Montreal General Hospital

Montreal, Quebec, Canada

Ultra-Med Research

Pointe-Claire, Quebec, Canada

Centre de recherche du CHUQ-L'hotel-Dieu de Quebec

Québec, Quebec, Canada

Countries

Canada

Other Identifiers

CURC - FIT-0002

Identifier Type: -

Identifier Source: org_study_id