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Androgen Deprivation Therapy

Flibanserin for Prostate Cancer (RAD 2003 Trial)

Phase 2
Recruiting
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
Endorsed reduced sexual interest.
Currently receiving gonadotropin releasing hormone agonist/antagonist monotherapy.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 weeks
Awards & highlights

RAD 2003 Trial 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.Check my eligibility
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).See study design
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.

RAD 2003 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have experienced a decrease in my sexual interest.
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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 was sexually active within the last 6 months before starting hormone therapy.
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I currently have a sexual partner.
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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.

RAD 2003 Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Patient-reported frequency of attempting sexual intercourse
Secondary outcome measures
Frequency of physician-assessed grade 3+ Adverse Events
Sexual Quality of Life (QoL)

RAD 2003 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

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,627 Previous Clinical Trials
40,927,291 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.

Media Library

Androgen deprivation therapy (Androgen Deprivation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04743934 — Phase 2
Prostate Adenocarcinoma Research Study Groups: Placebo + ADT, Flibanserin + ADT
Prostate Adenocarcinoma Clinical Trial 2023: Androgen deprivation therapy Highlights & Side Effects. Trial Name: NCT04743934 — Phase 2
Androgen deprivation therapy (Androgen Deprivation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04743934 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can you provide an overview of the previous studies utilizing Androgen deprivation therapy?

"Currently, two clinical studies are in progress concerning Androgen deprivation therapy. Neither of the active investigations is at Phase 3 yet; however, most trials dedicated to this treatment take place in Houston Texas with a couple other sites conducting research as well."

Answered by AI

Has there ever been a similar experiment to this one before?

"Androgen deprivation therapy has been studied since the beginning of 2020, when Sprout Pharmaceuticals initially sponsored a clinical trial involving 60 participants. After gaining Phase 2 drug approval following this first research effort, two new active studies are now being conducted across two cities in one country."

Answered by AI

What is the current enrolment count for this clinical experiment?

"Affirmative. According to clinicaltrials.gov, the trial was first posted on July 2nd 2021 and has since been updated as recently as July 20th 2022. At present, 50 patients are being sought by a single medical facility."

Answered by AI

Is enrollment in this trial available to qualified individuals?

"As per the information on clinicaltrials.gov, this research is in the process of enrolling participants. The trial was initially announced on July 2nd 2021 and went under its most recent update on July 20th 2022."

Answered by AI

To what extent can Androgen deprivation therapy be detrimental to individuals?

"Our team at Power has tallied the safety of Androgen deprivation therapy as a 2, since there is evidence for its safety but none yet for efficacy due to this being a Phase 2 trial."

Answered by AI
~13 spots leftby Mar 2025