Firmagon (Degarelix) Intermittent Therapy

Prostate Cancer Recurrent Clinical Trial

— FIT  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01512472
• Other study ID #: CURC - FIT-0002
• Status: Terminated
• Phase: Phase 4
• Start date: January 2012
• Est. completion date: January 2018

Study information

• Verified date: September 2019
• Source: Canadian Urology Research Consortium
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 144
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer Recurrent
• Prostatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Canada	Recherches Clinique /Clinical Research	Granby	Quebec
Canada	Centre of Clinical Research	Halifax	Nova Scotia
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	MUHC Montreal General Hospital	Montreal	Quebec
Canada	The Urology Specialists / Les Urologues Specialises	Montreal	Quebec
Canada	URLX Corporation	Ottawa	Ontario
Canada	Ultra-Med Research	Pointe Claire	Quebec
Canada	Centre de recherche du CHUQ-L'hotel-Dieu de Quebec	Quebec
Canada	Northeast Cancer Centre, Health Sciences North	Sudbury	Ontario
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
Canada	University Health Network	Toronto	Ontario
Canada	The Prostate Centre	Vancouver	British Columbia
Canada	Manitoba Prostate Centre	Winnipeg	Manitoba

Sponsors (2)

Lead Sponsor	Collaborator
Canadian Urology Research Consortium	Ferring Pharmaceuticals

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)