Flibanserin in Men Receiving Androgen Suppression for Prostate Cancer (RAD 2003)

RAD 2003/XUAB2104: Randomized Phase II Trial of Flibanserin in Men Receiving Androgen Suppression for Prostate Cancer

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Adenocarcinoma
• Intervention / Treatment: Drug: Flibanserin 100 MG; Drug: Androgen deprivation therapy; Drug: Placebo

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 metastatic or high-risk localized disease, and reduces rates of biochemical progression for men with intermediate-risk localized disease who receive radiation. The most common ADT agents modulate gonadotropin-releasing hormone to suppress the downstream testosterone production, resulting in testosterone levels similar to those observed following surgical castration (<20 ng/dL). Since male sexual interest is highly correlated with serum testosterone levels, loss of sexual interest is nearly universal among men who receive ADT.Sexual dysfunction is the most common complaint among men with prostate cancer and contributes to lower overall quality of life (QoL) experienced by men receiving ADT. Furthermore, the loss of sexual interest experienced during ADT is highly distressing for men with prostate cancer and their partners, which contributes additional psychological morbidity in these patients.

Flibanserin is approved for treatment of female hypoactive sexual desire disorder, and the safety profile of 100mg daily flibanserin is well described in premenopausal women.The safety profile of flibanserin in healthy men has been assessed in multiple phase I clinical trials, but has not been evaluated among men receiving ADT for prostate cancer.

This is a phase II randomized, double-blinded, placebo-controlled clinical trial designed to provide an initial estimate of the efficacy of flibanserin to promote sexual interest in men with prostate cancer receiving androgen suppression therapy and to confirm the safety profile. This study will take place at a single academic comprehensive cancer center.

Following confirmation of eligibility, participants who are enrolled in this study are randomized to receive daily flibanserin 100mg or placebo for a 12-week period.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Andrew McDonald, MD; Phone Number: (205) 934-5670; Email: flibanserinstudy@uabmc.edu
• Study Contact Backup: Name: Amanda Smith; Phone Number: (205) 644-1340; Email: flibanserinstudy@uabmc.edu

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • Recruiting
      • Amanda Smith
      • Contact: Amanda Smith; Phone Number: 205-644-1340; Email: flibanserinstudy@uabmc.edu
      • Contact: Kate Heinzman; Phone Number: 2056441340; Email: flibanserinstudy@uabmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Flibanserin + ADT; Flibanserin at 100mg by mouth once daily at bedtime while receiving androgen deprivation therapy (ADT).	Drug: Flibanserin 100 MG; Flibanserin 100mg tablets taken by mouth daily at bedtime; Drug: Androgen deprivation therapy; Androgen deprivation therapy consisting of a GnRH agonist or antagonist, choice of agent at discretion of treating physician.
Placebo Comparator: Placebo + ADT; Placebo at 100mg by mouth once daily at bedtime while receiving androgen deprivation therapy (ADT).	Drug: Androgen deprivation therapy; Androgen deprivation therapy consisting of a GnRH agonist or antagonist, choice of agent at discretion of treating physician.; Drug: Placebo; Visually identical placebo tablets taken by mouth daily at bedine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-reported frequency of attempting sexual intercourse	The number of patients in each arm reporting attempting sexual intercourse at least 3 times in the prior month (0-2 attempts vs. 3+ attempts) will be compared using the two-group chi-square test, or Fisher's exact test if the assumptions for the chi-square test are not tenable.	Baseline up to 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sexual Quality of Life (QoL)	Determined using T-scores (higher T-score indicates better QoL) from the PROMIS v2.0 Brief Sexual Function and Satisfaction (Male) form and comparing T-score between patients receiving flibanserin and patients receiving placebo.	Up to 12 weeks
Frequency of physician-assessed grade 3+ Adverse Events	Toxicity will be assessed by a physician investigator and scored using the CTCAE v5.0 scale.	Baseline up to 12 weeks

Collaborators and Investigators

• Sponsor: Andrew McDonald
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Andrew McDonald, MD, University of Alabama at Birmingham (UAB)

Study record dates

Study Major Dates

• Study Start (Actual): July 2, 2021
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: February 3, 2021
• First Submitted That Met QC Criteria: February 3, 2021
• First Posted (Actual): February 8, 2021

Study Record Updates

• Last Update Posted (Actual): March 21, 2024
• Last Update Submitted That Met QC Criteria: March 19, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Androgen Deprivation Therapy (ADT); Flibanserin
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Androgens
• Other Study ID Numbers: IRB-300006880; 5R21CA259808-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No