Phase 3 Prostate Cancer Trial, Recruiting NCT03701581 Sponsor: John Elfar Condition: Prostate Cancer
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Phase 3 Prostate Cancer Trial, Recruiting

NCT03701581
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:

  • Male patients who have prostate cancer that has not spread beyond the prostate (stages cT1c–T2c) and are planning to have a nerve-sparing robotic prostate removal surgery
  • People whose prostate-specific antigen (PSA) blood test result was below 15 ng/ml in the last 12 months, and whose prostate cancer has been confirmed by biopsy, and for whom additional treatments like radiation or hormone therapy are not expected to be needed after surgery
  • People aged between 45 and 75 years old
  • People who scored 17 or higher on a standard erectile function questionnaire (called the IIEF-5) at the time of screening
  • People who have had regular sexual activity for at least 6 months, including in the 12 weeks before their prostate biopsy or surgery
  • People who are willing to avoid any erectile dysfunction treatments until at least 3 months after surgery
  • People who are willing to take part and are able to give their informed consent to participate

Who may not be able to join:

  • People for whom additional treatment (such as radiation) is planned after surgery because the cancer was found to have spread further than expected, or because lymph nodes or surgical margins were affected
  • People who received treatment for their prostate cancer before surgery
  • People with a history of prostate cancer that has come back
  • People with a history of seizures, multiple sclerosis, stroke, or any other diagnosed neurological (nervous system) condition
  • People whose prostate cancer has spread beyond the prostate or to other parts of the body (stage T3 or higher)
  • People with a known allergy or sensitivity to a medication called 4-aminopyridine (4AP)
  • People who have had penile surgery other than circumcision or a specific type of minor urethral procedure
  • People with reduced kidney function, based on a kidney filtering rate test result below 60 mL/min
  • People currently taking any medication from the aminopyridine drug family for any reason

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 27 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: Rashid Sayyid, MD, University of Arizona

Phone: 520-626-6456

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
John Elfar
Registry
ClinicalTrials.gov
Start date
5 June 2021
Est. completion
1 July 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Michigan Incontinence Sympton Index (M-ISI) (change over time); International Index of Erectile Function (IIEF) (change over time); Placebo vs. Active Drug Questionnaire

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: 27 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