Prostate AdenocarcinomaPhase 2RAD 2003NCT04743934
Flibanserin in Men Receiving Androgen Suppression for Prostate Cancer
A Phase 2 study testing Flibanserin 100 MG and Androgen deprivation therapy in people with Prostate Adenocarcinoma, run by Andrew McDonald at 1 site in United States.
Trial 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 suppression. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Adenocarcinoma
- What is being tested?
- Flibanserin 100 MG and Androgen deprivation therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jul 2021to 1 Mar 2026
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35233
About this study
Official title: 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.
Read the 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.
- Conditions
- Prostate Adenocarcinoma
- Being tested
- Flibanserin 100 MG, Placebo, Androgen deprivation therapy
- Keywords
- Flibanserin, Androgen Deprivation Therapy (ADT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flibanserin 100 MGDrug
Flibanserin 100mg tablets taken by mouth daily at bedtime
PlaceboDrug
Visually identical placebo tablets taken by mouth daily at bedine
Androgen deprivation therapyDrug
Androgen deprivation therapy consisting of a GnRH agonist or antagonist, choice of agent at discretion of treating physician.
| Study group | Role | What they receive |
|---|---|---|
| Flibanserin + ADT | Experimental | Flibanserin at 100mg by mouth once daily at bedtime while receiving androgen deprivation therapy (ADT). Receives: Drug: Flibanserin 100 MG; Drug: Androgen deprivation therapy |
| Placebo + ADT | Placebo comparator | Placebo at 100mg by mouth once daily at bedtime while receiving androgen deprivation therapy (ADT). Receives: Drug: Placebo; Drug: Androgen deprivation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Reported Attempting Sexual Intercourse at Least 3 Times in the Prior Month
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.
Measured: Baseline up to 12 weeks
Secondary outcomes (2)
Sexual Quality of Life (QoL)
Determined using T-scores from the PROMIS v2.0 Brief Sexual Function and Satisfaction (Male) form and comparing T-score between patients receiving flibanserin and patients receiving placebo. Higher scores indicate better sexual functions. A T-score of 50 represents the population mean with a standard deviation of 10. The difference in 3 to 5 T-score points is generally considered a clinically meaningful change.
Measured: 12 weeks
Frequency of Patient Reported Grade 3+ Adverse Events
Toxicity will be assessed by a physician investigator and scored using the CTCAE v5.0 scale.
Measured: Baseline up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2021
- Study start2 Jul 2021
- Primary completion1 Mar 2025
- Study completion1 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andrew McDonald
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor-investigator, Andrew McDonald, University of Alabama at Birmingham
- Investigators
- Andrew McDonald, MD, Principal investigator, University of Alabama at Birmingham (UAB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04743934
- Sponsor's protocol ID
- IRB-300006880
- Other IDs
- 5R21CA259808-02
- Acronym
- RAD 2003
- Status last verified
- Jun 2026
- First submitted
- 3 Feb 2021
- Last updated
- 20 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RAD 2003/XUAB2104: Randomized Phase II Trial of Flibanserin in Men Receiving Androgen Suppression for Prostate Cancer
- ClinicalTrials.gov ID
- NCT04743934
- Acronym / sponsor ID
- RAD 2003 / IRB-300006880
- Conditions
- Prostate Adenocarcinoma
- Keywords
- Flibanserin, Androgen Deprivation Therapy (ADT)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Andrew McDonaldUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 2 Jul 2021 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 1 Mar 2026 (actual)
- First posted
- 8 Feb 2021 (actual)
- Results
- Posted 20 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Flibanserin + ADT | Experimental | Drug: Flibanserin 100 MG, Drug: Androgen deprivation therapyFlibanserin at 100mg by mouth once daily at bedtime while receiving androgen deprivation therapy (ADT). |
| Placebo + ADT | Placebo comparator | Drug: Placebo, Drug: Androgen deprivation therapyPlacebo at 100mg by mouth once daily at bedtime while receiving androgen deprivation therapy (ADT). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flibanserin 100 MGFlibanserin 100mg tablets taken by mouth daily at bedtime | Drug | Flibanserin + ADT |
| PlaceboVisually identical placebo tablets taken by mouth daily at bedine | Drug | Placebo + ADT |
| Androgen deprivation therapyAndrogen deprivation therapy consisting of a GnRH agonist or antagonist, choice of agent at discretion of treating physician. | Drug | Flibanserin + ADT, Placebo + ADT |
Primary outcome
Number of Participants Who Reported Attempting Sexual Intercourse at Least 3 Times in the Prior Month
Time frame: Baseline up to 12 weeks
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.
2 secondary outcomes
Sexual Quality of Life (QoL)
Time frame: 12 weeks
Frequency of Patient Reported Grade 3+ Adverse Events
Time frame: Baseline up to 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew McDonald, MD principal investigator
University of Alabama at Birmingham (UAB)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Flibanserin 100 MG and Androgen deprivation therapy in people with Prostate Adenocarcinoma, run by Andrew McDonald at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Reported Attempting Sexual Intercourse at Least 3 Times in the Prior Month (time frame: Baseline up to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.