Periprostatic Neurolysis in Prostate Cancer

NCT07100847 | Recruiting Phase 1

• 1 other identifier: STU20240058
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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

PROSTATE CANCER; NERVES; NEUROBIOLOGY OF CANCER; NEUROLYSIS

Keywords

HIGH RISK LOCALIZED PROSTATE CANCER

Outcome Measures

Primary Outcomes (1)

• Peritumoral adrenergic nerve density on final histology

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

  4 to 6 weeks after treatment initiation

Secondary Outcomes (3)

• Change in sexual health inventory for men (SHIM) score

  4 to 6 weeks after intervention

• Change in International Prostate Symptom Score (IPSS)

  4 to 6 weeks after intervention

• Change in post prostatectomy penile length

  6months after surgery

Study Arms (3)

Single injection neurolysis

EXPERIMENTAL

Single injection of ethanol for periprostatic neurolysis

Procedure: Periprostatic neurolysis with dehydrated alcohol (ethanol)

Two injection neurolysis

EXPERIMENTAL

Two temporally separated periprostatic ethanol injections

Procedure: Periprostatic neurolysis with dehydrated alcohol (ethanol)

No injection control

NO INTERVENTION

Interventions

Periprostatic neurolysis with dehydrated alcohol (ethanol) PROCEDURE

Pre-operative ultrasound guided periprostatic neurolysis by injection of dehydrated alcohol

Single injection neurolysis; Two injection neurolysis

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• Urology Care Foundation: collaborator
• American Urological Association: collaborator

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

Related Publications (1)

• Zahalka AH, Arnal-Estape A, Maryanovich M, Nakahara F, Cruz CD, Finley LWS, Frenette PS. Adrenergic nerves activate an angio-metabolic switch in prostate cancer. Science. 2017 Oct 20;358(6361):321-326. doi: 10.1126/science.aah5072.

  PMID: 29051371 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Urologic Oncology Fellow

Study Record Dates

• First Submitted: July 27, 2025
• First Posted: August 3, 2025
• Study Start: August 15, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2028
• Last Updated: September 9, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

US (1)