Recruiting

Peri-prostatic Neurolysis in High-risk Localized Prostate Cancer

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What is being tested

Periprostatic neurolysis with dehydrated alcohol (ethanol)

Procedure
Who is being recruted

Urogenital Diseases+7

+ Genital Diseases

+ Genital Diseases, Male

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: August 2025
See protocol details

Summary

Principal SponsorUniversity of Texas Southwestern Medical Center
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Study start date: August 15, 2025

Actual date on which the first participant was enrolled.

This study focuses on men with high-risk prostate cancer, which has a significant chance of spreading and becoming more serious over time. Often, cancer cells invade the nerves around the prostate, which can lead to more aggressive forms of cancer. Most prostate cancer that spreads moves to the bones, and the nerves connected to the prostate play a role in this process. By targeting these nerves, researchers hope to find new ways to stop the cancer from progressing after initial treatment. Previous studies have shown that using ethanol in small amounts can reduce the nerve density around the prostate, which might help slow down the spread of cancer. In this study, participants will receive either one or two injections of ethanol around the prostate to see which approach is more effective at reducing nerve density. These injections are given to see how well they can prevent the cancer from growing or spreading further. Researchers will monitor the effectiveness of the injections by measuring the changes in nerve density around the prostate. The study aims to refine this technique to maximize its potential benefits while ensuring it remains safe for patients. There may be risks associated with the procedure, but earlier studies have shown that it is generally well-tolerated without serious side effects.

Official TitlePhase 1b Window of Opportunity Study of Peri-prostatic Neurolysis in High-risk Localized Prostate Cancer 
NCT07100847
Principal SponsorUniversity of Texas Southwestern Medical Center
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

21 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Male

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesGenital Diseases, MaleGenital Neoplasms, MaleNeoplasmsNeoplasms by SiteProstatic DiseasesProstatic NeoplasmsUrogenital NeoplasmsMale Urogenital Diseases

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)

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Single injection of ethanol for periprostatic neurolysis

Group II

Experimental
Two temporally separated periprostatic ethanol injections

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

University of Texas Southwestern Medical Center

Dallas, United StatesSee the location
Recruiting
One Study Center