Firmagon (Degarelix) Intermittent Therapy

Phase 4

Terminated

• Conditions: Prostate Cancer Recurrent
• Interventions: Drug: degarelix

• Registration Number: NCT01512472
• Lead Sponsor: Canadian Urology Research Consortium

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.

Study Timeline

• Study First Submitted: 2011-11-10
• Study Start: 2012-01
• Study First Submitted QC: 2012-01-18
• Study First Posted: 2012-01-19
• Primary Completion: 2018-01
• Study Completion: 2018-01
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-19
• Last Update Posted: 2019-09-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 144

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
10 month degarelix therapy	degarelix	-
4 month degarelix therapy arm	degarelix	-

Primary Outcome Measures

Name	Time	Method
serum PSA	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

Secondary Outcome Measures

Name	Time	Method
serum PSA	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.

Trial Locations

Locations (15)

The Prostate Centre; 🇨🇦 Vancouver, British Columbia, Canada

Manitoba Prostate Centre; 🇨🇦 Winnipeg, Manitoba, Canada

Centre of Clinical Research; 🇨🇦 Halifax, Nova Scotia, Canada

McMaster Institute of Urology; 🇨🇦 Hamilton, Ontario, Canada

Centre of Applied Urological Research / Kingston General Hospital; 🇨🇦 Kingston, Ontario, Canada

London Health Sciences Centre; 🇨🇦 London, Ontario, Canada

URLX Corporation; 🇨🇦 Ottawa, Ontario, Canada

Northeast Cancer Centre, Health Sciences North; 🇨🇦 Sudbury, Ontario, Canada

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada

University Health Network; 🇨🇦 Toronto, Ontario, Canada

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