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Firmagon (Degarelix) Intermittent Therapy (FIT)

This study has been terminated.
(acrrual target was not being met)
Sponsor:
Collaborator:
Ferring Pharmaceuticals
Information provided by (Responsible Party):
Canadian Urology Research Consortium
ClinicalTrials.gov Identifier:
NCT01512472
First received: November 10, 2011
Last updated: October 13, 2016
Last verified: November 2012
  Purpose
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 Intervention Phase
Prostate Cancer Recurrent
Drug: degarelix
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Canadian Urology Research Consortium:

Primary Outcome Measures:
  • serum PSA [ Time Frame: approximately 15 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: at 4 months (4 mon arm) or 10 montths (10 mon arm) ] [ Designated as safety issue: No ]
    PSA nadir is described as the serum PSA value after the completion of either 4 months or 10 months of therapy.


Enrollment: 144
Study Start Date: January 2012
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01512472

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

Responsible Party: Canadian Urology Research Consortium
ClinicalTrials.gov Identifier: NCT01512472     History of Changes
Other Study ID Numbers: CURC - FIT-0002 
Study First Received: November 10, 2011
Last Updated: October 13, 2016
Health Authority: Canada: Health Canada

Keywords provided by Canadian Urology Research Consortium:
localized prostate cancer
degarelix
intermittent androgen deprivation therapy

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on December 05, 2016