Status:
ACTIVE_NOT_RECRUITING
Flibanserin in Men Receiving Androgen Suppression for Prostate Cancer
Lead Sponsor:
Andrew McDonald
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Prostate Adenocarcinoma
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief 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 suppre...
Detailed Description
More than 40,000 men with prostate cancer in the United States will begin androgen deprivation therapy (ADT) each year. ADT is an important part of treatment, because it improves survival for men with...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 2 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2026
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT04743934
Start Date
July 2 2021
End Date
March 1 2026
Last Update
May 4 2025
Active Locations (1)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233