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Firmagon (Degarelix) Intermittent Therapy (FIT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by Canadian Urology Research Consortium
Sponsor:
Collaborator:
Ferring Inc.
Information provided by (Responsible Party):
Canadian Urology Research Consortium
ClinicalTrials.gov Identifier:
NCT01512472
First received: November 10, 2011
Last updated: November 30, 2012
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.


Estimated 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
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

Contacts
Contact: Marlene Kebabdjian, BSW (416) 480 - 6100 ext 2890 marlene.kebabdjian@sunnybrook.ca
Contact: Irene McNeill, BScPhm (416) 480 - 6100 ext 2431 irene.mcneill@sunnybrook.ca

Locations
Canada, British Columbia
The Prostate Centre Recruiting
Vancouver, British Columbia, Canada, V6Z 3J5
Contact: Maureen Palmer    (604) 875-4818    maureen.palmer@vch.ca   
Principal Investigator: Alan So, MD         
Canada, Manitoba
Manitoba Prostate Centre Recruiting
Winnipeg, Manitoba, Canada, R3E 0V9
Contact: Paula Sitarik, RN    204-787-4411    paula.sitarik@cancercare.mb.ca   
Principal Investigator: Darryl Drachenberg, MD         
Canada, Nova Scotia
Centre of Clinical Research Recruiting
Halifax, Nova Scotia, Canada, B3H 1V7
Contact: Susan Winch    (902) 473-6604    susan.winch@cdha.nshealth.ca   
Principal Investigator: Ricardo Rendon, MD         
Canada, Ontario
McMaster Institute of Urology Recruiting
Hamilton, Ontario, Canada, L8N 4A6
Contact: Elizabeth Sidorkewicz    (905) 522-4528    sidorke@mcmaster.ca   
Principal Investigator: Anil Kapoor, MD         
Centre of Applied Urological Research / Kingston General Hospital Recruiting
Kingston, Ontario, Canada, K7L 3J7
Contact: Angela Black    (613) 548-7832    blacka@kgh.kari.net   
Principal Investigator: Robert Siemens, MD         
London Health Sciences Centre Recruiting
London, Ontario, Canada, N6A 5W9
Contact: Stephanie Giller    (519) 685-8500 ext 56601    stephanie.giller@lhsc.on.ca   
Principal Investigator: Joseph Chin, MD         
Sub-Investigator: Johnathan Izawa, MD         
URLX Corporation Not yet recruiting
Ottawa, Ontario, Canada, K1H 1A2
Contact: Tammy Knight       taknight@ottawahospital.on.ca   
Principal Investigator: John Mahoney, MD         
Northeast Cancer Centre, Health Sciences North Recruiting
Sudbury, Ontario, Canada, P3E 5J1
Contact: Cathy Simeoni    705-522-6237 ext 2400    csimeoni@hsnsudbury.ca   
Principal Investigator: Julie Bowen, MD         
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Marlene Kebabdjian, BA    (416) 480 - 6100 ext 2890    marlene.kebabdjian@sunnybrook.ca   
Contact: Irene McNeill, BScPhm    (416) 480 - 6100 ext 2431    irene.mcneill@sunnybrook.ca   
Principal Investigator: Andrew Loblaw, MD         
University Health Network Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Vasant Solanki    $16) 946-4501 ext 3351    vasant.solanki@uhn.ca   
Principal Investigator: Neil Fleshner, MD         
Canada, Quebec
Recherches Clinique /Clinical Research Recruiting
Granby, Quebec, Canada, J2G 8Z9
Contact: Claudette Robert    (450) 378-8805    robert@theradev.ca   
Principal Investigator: Paul Ouellette, MD         
MUHC Montreal General Hospital Recruiting
Montreal, Quebec, Canada, H3G 1A4
Contact: Wendella Hamilton    (514) 934-1934 ext 44279    wendella.hamilton@yahoo.ca   
Principal Investigator: William Kassouf, MD         
Sub-Investigator: Simon Tanguay, MD         
The Urology Specialists / Les Urologues Specialises Recruiting
Montreal, Quebec, Canada, H2X 1N8
Contact: Jose Sosa    (514) 393-1222    urotrial@gmail.com   
Principal Investigator: Pierre Karakiewicz, MD         
Ultra-Med Research Recruiting
Pointe Claire, Quebec, Canada, H9R 4S3
Contact: Karen Anderson    (514) 426-8008    karen@ultramed.ca   
Principal Investigator: David Eiley, MD         
Canada
Centre de recherche du CHUQ-L'hotel-Dieu de Quebec Recruiting
Quebec, Canada, G1R 3S1
Contact: Helene Dombrowski    (418) 691-5151 ext 21623    helene.dombrowski@crhdq.ulaval.ca   
Principal Investigator: Yves Fradet, MD         
Sponsors and Collaborators
Canadian Urology Research Consortium
Ferring Inc.
Investigators
Principal Investigator: Laurence Klotz, MD Canadian Urology Research Consortium
  More Information

No publications provided

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: November 30, 2012
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 Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on November 27, 2014