Firmagon (Degarelix) Intermittent Therapy (FIT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01512472
Recruitment Status : Terminated (acrrual target was not being met)
First Posted : January 19, 2012
Last Update Posted : October 14, 2016
Ferring Pharmaceuticals
Information provided by (Responsible Party):
Canadian Urology Research Consortium

November 10, 2011
January 19, 2012
October 14, 2016
January 2012
December 2016   (Final data collection date for primary outcome measure)
serum PSA [ Time Frame: approximately 15 months ]
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 Archive Site
serum PSA [ Time Frame: at 4 months (4 mon arm) or 10 montths (10 mon arm) ]
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.
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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 Identifier (NCT Number) in Medline.
Same as current
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
Sexes Eligible for Study: Male
18 Years to 85 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
CURC - FIT-0002
Not Provided
Not Provided
Canadian Urology Research Consortium
Canadian Urology Research Consortium
Ferring Pharmaceuticals
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