Periprostatic nerve‑blocking alcohol injections for high‑risk prostate cancer
Phase 1b Window of Opportunity Study of Peri-prostatic Neurolysis in High-risk Localized Prostate Cancer
This study will test whether one versus two alcohol injections to block nerves around the prostate can slow or stop cancer spread in men with high‑risk prostate cancer who plan to have their prostate removed.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 21 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | University of Texas Southwestern Medical Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT07100847 on ClinicalTrials.gov |
What this trial studies
This Phase 1 study compares the effect of one versus two periprostatic injections of dehydrated alcohol on prostate nerve density and subsequent cancer progression in men with high‑risk prostate cancer. Eligible participants are surgical candidates planning radical prostatectomy, have no prior prostate cancer treatment, and have no metastatic disease on PSMA PET. The team will measure changes in prostatic nerve density and monitor safety and oncologic outcomes after treatment and surgery. The trial builds on prior animal work and a Phase 1a human study that showed the procedure was well tolerated and reduced prostatic nerve density by about 30%.
Who should consider this trial
Good fit: Men with NCCN‑defined high‑risk localized prostate cancer who are surgical candidates for radical prostatectomy, with ≤cT3a on MRI and no seminal vesicle, nodal, or metastatic disease on PSMA PET, and no prior prostate cancer treatment.
Not a fit: Men with metastatic disease, prior prostate cancer treatments, non‑surgical candidates, or low‑risk disease are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, this approach could reduce nerve signals that help prostate cancer spread and potentially slow or prevent metastasis after definitive treatment.
How similar studies have performed: Preclinical mouse studies showed blocking prostate nerve activity reduced tumor growth and spread, and a Phase 1a human study (NCT06703437) found periprostatic ethanol injections were well tolerated and reduced nerve density by about 30%, so the approach has promising but early supportive data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: High risk prostate cancer as defined by NCCN criteria Desires surgical disease treatment (radical prostatectomy) Surgical candidate (for radical prostatectomy) ≤cT3a on MRI No seminal vesicle, lymph node, or metastatic disease on PSMA PET No prior prostate cancer treatment (including androgen deprivation therapy, radiation therapy, focal therapy, cryo therapy)
Where this trial is running
Dallas, Texas
- University of Texas Southwestern Medical Center — Dallas, Texas, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.