Periprostatic Neurolysis in Prostate Cancer

Not Applicable

Recruiting

• Conditions: PROSTATE CANCER; NEUROBIOLOGY OF CANCER; NEUROLYSIS; NERVES

• Registration Number: NCT07100847
• Lead Sponsor: University of Texas Southwestern Medical Center

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.

Detailed Description

Men with high-risk prostate cancer are at the greatest risk for clinical progression, with 22 to 40% developing metastatic disease within 10 years of initial treatment. Furthermore, the finding of perineural invasion (PNI) on pathology (when prostate cancer cells invade the nerves that innervate the prostate), is associated with higher Gleason grades and an approximate doubling in risk of lethal prostate cancer. As 90% of prostate cancer metastasis involve the bone marrow, and 97% of bone marrow metastasis involve the lumbar vertebrate from which the pre-ganglionic sympathetic nerves that innervate the prostate derive, targeting this neuro-anatomic connection between the prostate and its primary site of metastasis is an active area of investigation. Therefore, development of therapeutic strategies targeting nerves to prevent clinical progression after definitive therapy for prostate cancer are urgently needed. In a Phase 1a dose escalation study (NCT06703437) we recently demonstrated that periprostatic neurolysis with 5mL pure ethanol was well tolerated with no AEs. This resulted in an approximate 30% reduction in prostatic adrenergic nerve density. The goal of this study is to optimize prostatic denervation by comparing the denervation efficiency of 1 vs 2 periprostatic ethanol injections.

Study Timeline

• Study First Submitted: 2025-07-27
• Study First Submitted QC: 2025-07-27
• Status Verified: 2025-08
• Study Start: 2025-08-01
• Study First Posted: 2025-08-03
• Last Update Submitted: 2025-08-24
• Last Update Posted: 2025-08-29
• Primary Completion: 2026-08
• Study Completion: 2028-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 21

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Peritumoral adrenergic nerve density on final histology	4 to 6 weeks after treatment initiation	Will quantify degree of neurolysis by measuring decrease in adrenergic nerve density on radical prostatectomy specimen histology

Secondary Outcome Measures

Name	Time	Method
Change in sexual health inventory for men (SHIM) score	4 to 6 weeks after intervention	Change in erectile function as measured by SHIM score at enrollment and 4 to 6 weeks after periprostatic neurolysis
Change in International Prostate Symptom Score (IPSS)	4 to 6 weeks after intervention	Change in lower urinary tract symptoms as measured by IPSS questionnaire at baseline and after neurolysis
Change in post prostatectomy penile length	6months after surgery	Change in penile length post prostatectomy compared to baseline

Trial Locations

Locations (1)

University of Texas Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States