Flibanserin for Prostate Cancer

(RAD 2003 Trial)

Not currently recruiting at 1 trial location

Overseen By Amanda Smith

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: Andrew McDonald

Must be taking: GnRH agonist/antagonist

Must not be taking: CYP3A4 inhibitors, MAO inhibitors

Disqualifiers: Alcohol use, Erectile dysfunction, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether flibanserin, a medication, can boost sexual interest in men with prostate cancer undergoing androgen suppression therapy (also known as androgen deprivation therapy, a type of hormone therapy). Participants will receive either flibanserin or a placebo (a pill with no active drug) alongside their ongoing cancer treatment. Men with prostate cancer who have noticed a drop in sexual interest while on androgen deprivation therapy and have attempted to be sexually active might be suitable candidates. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking certain medications like moderate or strong CYP3A4 inhibitors or monoamine oxidase inhibitors.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that flibanserin is generally safe when tested in healthy men. However, it has not been specifically studied in men with prostate cancer undergoing hormone therapy. The most common side effects of flibanserin include dizziness, sleepiness, nausea, tiredness, trouble sleeping, and dry mouth. These side effects were observed in other studies, so they might not be exactly the same for everyone in this trial.

This trial is in a moderate phase, meaning some safety information is available, but more data is needed to understand how well men in this specific situation handle flibanserin. Prospective participants should discuss any concerns with the medical team conducting the study. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Flibanserin is unique because it wasn't originally designed for prostate cancer. Instead, it's being explored for its potential benefits in this area due to its novel mechanism of action. While most prostate cancer treatments focus on reducing testosterone levels through androgen deprivation therapy (ADT), Flibanserin targets serotonin receptors in the brain, which may influence cancer progression in a different way. Researchers are excited about this treatment because it opens up a new avenue for potentially managing prostate cancer beyond the standard hormone-based therapies.

What evidence suggests that flibanserin might be an effective treatment for promoting sexual interest in men with prostate cancer?

Research has shown that flibanserin, initially used to increase sexual desire in women, might also benefit men with prostate cancer undergoing androgen deprivation therapy (ADT) who have lost interest in sex. In this trial, some participants will receive flibanserin alongside ADT to evaluate its potential to boost sexual desire in these men. Although researchers have tested the safety of flibanserin in healthy men, its effectiveness for men on ADT for prostate cancer remains under study. Early results appear promising, but further research is necessary to confirm these findings. ^{1 2 3 5 6}

Who Is on the Research Team?

Andrew McDonald, MD

Principal Investigator

University of Alabama at Birmingham (UAB)

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have experienced a decrease in my sexual interest.

I am currently on hormone therapy for my condition.

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

Exclusion Criteria

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

I am experiencing symptoms due to my active prostate cancer.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive daily flibanserin 100mg or placebo for a 12-week period while undergoing androgen deprivation therapy

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Androgen deprivation therapy
• Flibanserin
• Placebo

Trial Overview 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).

How Is the Trial Designed?

Group I: Flibanserin + ADT Experimental Treatment 2 Interventions

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

Group II: Placebo + ADT Placebo Group 2 Interventions

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

Androgen deprivation therapy is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Androgen deprivation therapy for:

• Prostate cancer
• Metastatic prostate cancer
• Locally advanced prostate cancer

Approved in United States as Androgen deprivation therapy for:

• Prostate cancer
• Metastatic prostate cancer
• Locally advanced prostate cancer

Approved in Canada as Androgen deprivation therapy for:

• Prostate cancer
• Metastatic prostate cancer
• Locally advanced prostate cancer

Who Is Running the Clinical Trial?

Andrew McDonald

Lead Sponsor

Trials

1

Recruited

40+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Androgen deprivation therapy (ADT) is effective for managing symptoms of prostate cancer but can lead to significant side effects that worsen over time, and it does not improve survival in men with localized disease.

Neoadjuvant ADT combined with external beam radiation has been shown to enhance survival in men with locally advanced prostate cancer, while immediate adjuvant ADT does not provide benefits for most men after radical prostatectomy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The timing and extent of androgen deprivation therapy for prostate cancer: weighing the clinical evidence. Ginzburg, S., Albertsen, PC.[2019]

Citations

1. reporter.nih.gov reporter.nih.gov/search/kcT0tKd5JUuOzAQXSUHR8w/project-details/10195766

A Randomized Phase II Trial of Flibanserin in Men Receiving ... We hypothesize that flibanserin can be used to increase sexual desire among men receiving ADT for prostate cancer.

2. trialx.com trialx.com/clinical-trials/listings/237398/flibanserin-in-men-receiving-androgen-suppression-for-prostate-cancer/

Flibanserin in Men Receiving Androgen Suppression for ... The safety profile of flibanserin in healthy men has been assessed in multiple phase I clinical trials, but has not been evaluated among men ...

3. prevention.cancer.gov prevention.cancer.gov/funding-and-grants/funded-grants/R21CA259808

Funded Grants | Division of Cancer Prevention We hypothesize that flibanserin can be used to increase sexual desire among men receiving ADT for prostate cancer.

4. prevention.cancer.gov prevention.cancer.gov/clinical-trials/clinical-trials-search/nct04743934

Flibanserin in Men Receiving Androgen Suppression for ... This is a double-blinded, placebo-controlled randomized phase II clinical trial investigating whether flibanserin promotes sexual interest in men with ...

5. urologytimes.com urologytimes.com/view/what-urologists-can-expect-in-q4-of-2025

What urologists can expect in Q4 of 2025 The safety and efficacy of flibanserin in ... Enhancing Prostate Cancer Outcomes – The Role of PSMA and Targeted Treatment Strategies.

6. urologytimes.com urologytimes.com/view/fda-grants-priority-review-to-expanded-indication-of-flibanserin-in-hsdd

FDA grants priority review to expanded indication of ... The most common AEs among patients treated with flibanserin were dizziness, somnolence, nausea, fatigue, insomnia, and dry mouth.