Firmagon (Degarelix) Intermittent Therapy (FIT)

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

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.

Study Overview

• Status: Terminated
• Conditions: Prostate Cancer Recurrent
• Intervention / Treatment: Drug: degarelix

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 Type: Interventional
• Enrollment (Actual): 144
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Quebec, Canada, G1R 3S1
    • Centre de recherche du CHUQ-L'hotel-Dieu de Quebec
  • British Columbia
    • Vancouver, British Columbia, Canada, V6Z 3J5
      • The Prostate Centre
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3E 0V9
      • Manitoba Prostate Centre
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 1V7
      • Centre of clinical research
  • Ontario
    • Hamilton, Ontario, Canada, L8N 4A6
      • McMaster Institute of Urology
    • Kingston, Ontario, Canada, K7L 3J7
      • Centre of Applied Urological Research / Kingston General Hospital
    • London, Ontario, Canada, N6A 5W9
      • London Health Sciences Centre
    • Ottawa, Ontario, Canada, K1H 1A2
      • URLX Corporation
    • Sudbury, Ontario, Canada, P3E 5J1
      • Northeast Cancer Centre, Health Sciences North
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Health Sciences Centre
    • Toronto, Ontario, Canada, M5G 2M9
      • University Health Network
  • Quebec
    • Granby, Quebec, Canada, J2G 8Z9
      • Recherches Clinique /Clinical Research
    • Montreal, Quebec, Canada, H2X 1N8
      • The Urology Specialists / Les Urologues Specialises
    • Montreal, Quebec, Canada, H3G 1A4
      • MUHC Montreal General Hospital
    • Pointe Claire, Quebec, Canada, H9R 4S3
      • Ultra-Med Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Canadian Urology Research Consortium
• Collaborators: Ferring Pharmaceuticals
• Investigators: Principal Investigator: Laurence Klotz, MD, Canadian Urology Research Consortium

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): January 1, 2018
• Study Completion (Actual): January 1, 2018

Study Registration Dates

• First Submitted: November 10, 2011
• First Submitted That Met QC Criteria: January 18, 2012
• First Posted (Estimate): January 19, 2012

Study Record Updates

• Last Update Posted (Actual): September 23, 2019
• Last Update Submitted That Met QC Criteria: September 19, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: intermittent androgen deprivation therapy; localized prostate cancer; degarelix
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: CURC - FIT-0002