Status:
TERMINATED
Firmagon (Degarelix) Intermittent Therapy
Lead Sponsor:
Canadian Urology Research Consortium
Collaborating Sponsors:
Ferring Pharmaceuticals
Conditions:
Prostate Cancer Recurrent
Eligibility:
MALE
18-85 years
Phase:
PHASE4
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 efficac...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2018
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT01512472
Start Date
January 1 2012
End Date
January 1 2018
Last Update
September 23 2019
Active Locations (15)
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1
The Prostate Centre
Vancouver, British Columbia, Canada, V6Z 3J5
2
Manitoba Prostate Centre
Winnipeg, Manitoba, Canada, R3E 0V9
3
Centre of Clinical Research
Halifax, Nova Scotia, Canada, B3H 1V7
4
Northeast Cancer Centre, Health Sciences North
Greater Sudbury, Ontario, Canada, P3E 5J1