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Androgen Deprivation Therapy

Flibanserin for Prostate Cancer (RAD 2003 Trial)

Phase 2

Waitlist Available

Led By Andrew McDonald, MD

Research Sponsored by Andrew McDonald

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Currently receiving gonadotropin releasing hormone agonist/antagonist monotherapy.

No other antineoplastic therapy planned during study period.

Must not have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 weeks

Summary

This trial is testing whether flibanserin, a drug typically used to treat low sexual interest in women, can promote sexual interest in men with prostate cancer who are receiving androgen suppression (a treatment that lowers testosterone levels). The trial is double-blinded, meaning that neither the participants nor the researchers will know who is receiving the drug and who is receiving the placebo until the trial is over.

Who is the study for?

Men over 18 with prostate cancer, currently on hormone therapy to lower testosterone, who have a sexual partner and want to improve their sexual interest. They must be able to take oral meds, have no severe liver issues, not use certain other drugs or heavy alcohol, and can't be planning other cancer treatments during the study.

What is being tested?

The trial is testing if Flibanserin increases sexual desire in men undergoing hormone therapy for prostate cancer. It's a phase II study where participants are randomly given either Flibanserin or a placebo without knowing which one they receive (double-blinded).

What are the potential side effects?

Flibanserin may cause side effects like sleepiness, dizziness, nausea, fatigue, insomnia and dry mouth. Since it's being compared with a placebo in this trial, any additional side effects will be closely monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am currently on hormone therapy for my condition.

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I am not planning to receive any cancer treatments other than the study.

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I can take pills and will follow the study plan.

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I am a man older than 18.

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My prostate cancer diagnosis was confirmed through a tissue examination.

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I do not have symptoms from my prostate cancer spreading.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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Before hormone therapy, I had erection issues not solved by medications like Viagra.

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I am experiencing symptoms due to my active prostate cancer.

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I am currently taking a medication that is a monoamine oxidase inhibitor.

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I am not on prostate cancer treatment other than hormone therapy or abiraterone.

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I am not taking any strong or moderate drugs that affect liver enzymes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Patient-reported frequency of attempting sexual intercourse

Secondary study objectives

Frequency of physician-assessed grade 3+ Adverse Events

Sexual Quality of Life (QoL)

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Flibanserin + ADTExperimental Treatment2 Interventions

Flibanserin at 100mg by mouth once daily at bedtime while receiving androgen deprivation therapy (ADT).

Group II: Placebo + ADTPlacebo Group2 Interventions

Placebo at 100mg by mouth once daily at bedtime while receiving androgen deprivation therapy (ADT).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Androgen deprivation therapy

2021

Completed Phase 4

~260

0 / 11Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,958 Previous Clinical Trials

41,112,536 Total Patients Enrolled

Andrew McDonaldLead Sponsor

Andrew McDonald, MD5.03 ReviewsPrincipal Investigator - University of Alabama at Birmingham (UAB)

University of Alabama at Birmingham

2 Previous Clinical Trials

253 Total Patients Enrolled

5Patient Review

Dr. McDonald was easy to talk to and took time to answer all of my questions. I was very impressed with UAB and Dr. McDonald and feel I’m getting the highest level of care. Dr. McDonald was also very compassionate and personal as he discussed my care. Dr. McDonald made me confident that my case had been given much time, consideration, and planning.