Firmagon (Degarelix) Intermittent Therapy

• Status: Terminated
• Trial end date: 2018-01-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Canadian Urology Research Consortium
• Collaborator: Ferring Pharmaceuticals

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