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

PROSTATE CANCER
+1

+ NERVES
+ NEUROBIOLOGY OF CANCER
Over 18 Years
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: August 2025

Summary

Principal SponsorUniversity of Texas Southwestern Medical Center
Last updated: September 9, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: August 15, 2025Actual 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 
Principal SponsorUniversity of Texas Southwestern Medical Center
Last updated: September 9, 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 enrolledTotal 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.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation
: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

None (Single-arm trial)
: If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment
: Everyone gets the same treatment.

Cross-over assignment
: Participants switch between treatments during the study.

Factorial assignment
: Participants receive different combinations of treatments.

Sequential assignment
: Participants receive treatments one after another in a specific order, possibly based on individual responses.

Other assignment
: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled
: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
MaleBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
PROSTATE CANCER
NERVES
NEUROBIOLOGY OF CANCER
NEUROLYSIS
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
3 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
Group III
No Intervention
Study Objectives
Primary Objectives

Will quantify degree of neurolysis by measuring decrease in adrenergic nerve density on radical prostatectomy specimen histology
Secondary Objectives

Change in erectile function as measured by SHIM score at enrollment and 4 to 6 weeks after periprostatic neurolysis

Change in lower urinary tract symptoms as measured by IPSS questionnaire at baseline and after neurolysis

Change in penile length post prostatectomy compared to baseline

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 CenterDallas, United StatesSee the location

Recruiting
One Study Center