Peri-prostatic Neurolysis in High-risk Localized Prostate Cancer
Periprostatic neurolysis with dehydrated alcohol (ethanol)
Urogenital Diseases+7
+ Genital Diseases
+ Genital Diseases, Male
Treatment Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.21 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
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.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalStudy 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