Actively Recruiting

Phase 1
Age: 18Years +
MALE
NCT07100847

Periprostatic Neurolysis in Prostate Cancer

Led by University of Texas Southwestern Medical Center · Updated on 2025-09-09

21

Participants Needed

1

Research Sites

154 weeks

Total Duration

On this page

Sponsors

U

University of Texas Southwestern Medical Center

Lead Sponsor

U

Urology Care Foundation

Collaborating Sponsor

AI-Summary

What this Trial Is About

The purpose of this research study is to assess whether inhibiting nerve activity to the prostate delays progression of disease in men with high-risk clinical features for prostate cancer. Prostate cancer has been shown to invade nerves, a mechanism that is thought to be involved in prostate cancer spread in men with high-risk cancer. When nerve activity to the prostate is blocked in mice with prostate cancer, prostate cancer growth and spread are inhibited. In a previous study we showed that doing so in humans was safe and may have anticancer therapeutic effect. In this study we will test whether one versus two injections of nerve blocking agent is more effective at reducing nerves in the prostate and whether it will slow/stop spread of prostate cancer after treatment.

CONDITIONS

Official Title

Periprostatic Neurolysis in Prostate Cancer

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Male with high-risk prostate cancer as defined by NCCN criteria
  • Desires surgical treatment with radical prostatectomy
  • Candidate for radical prostatectomy surgery
  • Clinical stage ≤ cT3a on MRI
  • No seminal vesicle invasion, lymph node involvement, or metastatic disease on PSMA PET scan
  • No prior prostate cancer treatment including androgen deprivation therapy, radiation, focal therapy, or cryotherapy
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

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Trial Site Locations

Total: 1 location

1

University of Texas Southwestern Medical Center

Dallas, Texas, United States, 75390

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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