Clinical trial NCT01512472: Firmagon (Degarelix) Intermittent Therapy
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Prostate Cancer Recurrent
Keywords: localized prostate cancer
degarelix
intermittent androgen deprivation therapy
Lead sponsor: Canadian Urology Research Consortium
Sponsor class: OTHER
Collaborators: name: Ferring Pharmaceuticals
First posted: 2012-01-19
Enrollment: 144
Sex: MALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
measure: serum PSA
timeFrame: approximately 15 months
Secondary outcomes:
measure: serum PSA
timeFrame: at 4 months (4 mon arm) or 10 montths (10 mon arm)
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: The Prostate Centre
state: British Columbia
city: Winnipeg
country: Canada
facility: Manitoba Prostate Centre
state: Manitoba
city: Halifax
country: Canada
facility: Centre of Clinical Research
state: Nova Scotia
city: Hamilton
country: Canada
facility: McMaster Institute of Urology
state: Ontario
city: Kingston
country: Canada
facility: Centre of Applied Urological Research / Kingston General Hospital
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Ottawa
country: Canada
facility: URLX Corporation
state: Ontario
city: Sudbury
country: Canada
facility: Northeast Cancer Centre, Health Sciences North
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
city: Granby
country: Canada
facility: Recherches Clinique /Clinical Research
state: Quebec
city: Montreal
country: Canada
facility: The Urology Specialists / Les Urologues Specialises
state: Quebec
city: Montreal
country: Canada
facility: MUHC Montreal General Hospital
state: Quebec
city: Pointe Claire
country: Canada
facility: Ultra-Med Research
state: Quebec
city: Quebec
country: Canada
facility: Centre de recherche du CHUQ-L'hotel-Dieu de Quebec
Study officials:
affiliation: Canadian Urology Research Consortium
name: Laurence Klotz, MD
role: PRINCIPAL_INVESTIGATOR
References: