Phase 3 Prostate Cancer Trial, Recruiting NCT05381103 Sponsor: Five Eleven Pharma, Inc. Condition: Prostate Cancer
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Phase 3 Prostate Cancer Trial, Recruiting

NCT05381103
Recruiting Phase 3

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People diagnosed with prostate cancer that meets certain severity levels based on how the cancer cells look under a microscope (called a Gleason score), ranging from moderately aggressive to highly aggressive (confirm with trial site for exact score requirements)
  • People who currently have no or only mild-to-moderate difficulty getting erections, based on a standard questionnaire score of 17 or higher out of 25
  • People who want to preserve their ability to get erections after treatment
  • People who have had, or are planned to have, a standard MRI scan within 6 months of their scheduled surgery — note that if this condition is not met, the trial site may arrange a research MRI at no cost to the participant
  • People whose treating cancer doctor has recommended surgical removal of the prostate, with surgery planned to take place within 90 days of agreeing to join the trial

Who may not be able to join:

  • People currently taking part in, or who have taken part within the last 30 days in, another research trial that involves exposure to radiation
  • People for whom an MRI scan would not be safe, for example due to certain metal implants in the body
  • People with a serious ongoing or recent medical, neurological, or other health condition that, in the lead researcher's judgement, could put the person at risk, make it difficult to complete the study, or affect the study results

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 26 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Clinton Bahler, MD, Indiana University

Phone: 317-274-1791

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
Five Eleven Pharma, Inc.
Registry
ClinicalTrials.gov
Start date
1 October 2021
Est. completion
1 June 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

IIEF-EF sub scale score; IIEF-EF sub scale score; IIEF-EF sub scale score; IIEF-EF sub scale score; IIEF-EF sub scale score

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov