Phase 2 Prostate Cancer Trial, Recruiting
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 scheduled to have robotic-assisted laparoscopic prostate surgery (a type of minimally invasive prostate removal) performed by Dr. B. Miles at Houston Methodist
- Men between the ages of 40 and 70 (inclusive)
- People diagnosed with prostate cancer that has not spread beyond the prostate, at an early stage (classified as T1 or T2, with no spread to lymph nodes or other parts of the body)
- People whose prostate cancer has a Gleason score (a measure of how aggressive the cancer appears) of less than 7
- People with a score above 20 on a standard sexual function questionnaire (called the IIEF-5) before surgery, indicating good sexual function (confirm with trial site)
- People with testosterone blood levels above 300 ng/dL and normal free testosterone levels
- People expected to live at least 10 more years
- People with a general health and activity level rated at 2 or below on the Zubrod scale, which measures how much a condition limits daily activities (confirm with trial site)
- People who are willing to sign a consent form acknowledging this is a research study
- People who are willing to attempt sexual intercourse at least 5 times per month after regaining urinary control following surgery
- People who have a partner willing to complete a sexual survey questionnaire as part of the study
- People who were already taking certain medications for erectile dysfunction (such as sildenafil, tadalafil, vardenafil, or avanafil) for at least 6 months before surgery — these medications may be continued before and after surgery
- People who have received clearance from a heart specialist (cardiologist) before joining
Who may not be able to join:
- People with a physical abnormality of the penis, such as Peyronie's disease (a condition that causes scar tissue and curved, painful erections)
- People with hypogonadism (a condition where the body does not produce enough testosterone)
- People currently taking any medication that lowers male hormone (androgen) levels, such as hormone-blocking treatments used in prostate cancer management
- People with elevated liver enzyme levels (AST above 40 U/L or ALT above 33 U/L), blood sugar levels above 180 mg/dL, or psychiatric conditions that require medication
- People who have previously received or are currently receiving hormone therapy, chemotherapy, radiation therapy, immunotherapy, or are participating in another research drug trial
- People who have previously had a penile implant or surgery on the blood vessels of the penis
- People who use or have used Trimix injections (a combination medication injected into the penis) before or after surgery
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.
GP referral letter
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Trial details
Where this trial is recruiting
Primary endpoints
Change in erectile function by IIEF; Change in erectile function by Epic 26; Number of Participants With Severe Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs, Immune-Related Adverse Events (irAE)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 20 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.