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
18 Years
85 Years
Male
Prostate Cancer Recurrent
Trial Information
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
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
serum PSA
Outcome Description:
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
Outcome Time Frame:
approximately 15 months
Safety Issue:
No
Principal Investigator
Laurence Klotz, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Canadian Urology Research Consortium
Authority:
Canada: Health Canada
Study ID:
CURC - FIT-0002
NCT ID:
NCT01512472
Start Date:
January 2012
Completion Date:
December 2017
Related Keywords:
- Prostate Cancer Recurrent
- localized prostate cancer
- degarelix
- intermittent androgen deprivation therapy
- Prostatic Neoplasms
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