Flibanserin in Men Receiving Androgen Suppression for Prostate Cancer

• Status: Recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: Male

Summary

This is a double-blinded, placebo-controlled randomized phase II clinical trial investigating whether flibanserin promotes sexual interest in men with prostate cancer who are receiving androgen suppression.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Andrew McDonald
• Treatments: Androgens

Criteria

Inclusion Criteria:

• Provision of signed and dated informed consent form.

• Stated willingness to comply with all study procedures and availability for the duration of the study.

• Ability to take oral medication and be willing to adhere to the study regimen.

• Male age >18 years.

• Histologically confirmed prostate cancer.

• Currently receiving gonadotropin releasing hormone agonist/antagonist monotherapy.

• Serum testosterone <50 ng/dL.

• Serum AST and ALT less than 2 times upper limit of normal.

• Endorsed reduced sexual interest.

• Attempted intercourse.

• Current sexual partner.

• Was sexually active with partner within 6 months prior to ADT.

• No other antineoplastic therapy planned during study period.

• No active symptoms attributable to systemic prostate cancer.

Exclusion Criteria:

• Current systemic prostate cancer treatment besides GnRH agonist/antagonist, anti-androgens, or abiraterone.

• Prior to ADT had erections not firm enough for intercourse despite use of pharmacologic agents such as phosphodiesterase-5 inhibitors.

• Current symptoms attributable to active prostate cancer

• Moderate or heavy alcohol use (>2 drinks/day)

• Concurrent moderate or strong CYP3A4 inhibitors

• Concurrently taking medication classified as a monoamine oxidase inhibitor.