Firmagon (Degarelix) Intermittent Therapy (FIT)

This study is currently recruiting participants.
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

November 10, 2011
November 30, 2012
January 2012
December 2016   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01512472 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Firmagon (Degarelix) Intermittent Therapy
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostate Cancer Recurrent
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: 10 month degarelix therapy
    Intervention: Drug: degarelix
  • Active Comparator: 4 month degarelix therapy arm
    Intervention: Drug: degarelix
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
144
December 2017
December 2016   (final data collection date for primary outcome measure)

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
Male
18 Years to 85 Years
No
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
Canada
 
NCT01512472
CURC - FIT-0002
No
Canadian Urology Research Consortium
Canadian Urology Research Consortium
Ferring Inc.
Principal Investigator: Laurence Klotz, MD Canadian Urology Research Consortium
Canadian Urology Research Consortium
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP