Periprostatic Neurolysis in Prostate Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-15

Study Completion Date

2028-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study Looking at a New Nerve Surgery to Help Men Regain Erections After Prostate Cancer Surgery

NCT07188064

Prostate Cancer Erectile Dysfunction Following Radical Prostatectomy

NOT_YET_RECRUITING NA

Study of Nerve Reconstruction Using AVANCE in Subjects Who Undergo Robotic Assisted Prostatectomy for Treatment of Prostate Cancer

NCT00953277

Peripheral Nerve Injury Prostate Cancer Radical Prostatectomy +2 more

COMPLETED PHASE4

Prostate Capsule Sparing Cystectomy and Nerve-sparing Radical Cystoprostatectomy in Men With Bladder Cancer

NCT01824329

Bladder Cancer Transitional Cell Carcinoma of the Bladder

COMPLETED PHASE2

Brain and Pelvic Floor Muscle Activity of Patients Who Had or Are Undergoing Robot-Assisted Radical Prostatectomy

NCT04646434

Prostate Carcinoma

RECRUITING NA

Partial Prostatectomy for Prostate Cancer

NCT06624813

Prostate Cancer

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

PROSTATE CANCER NERVES NEUROBIOLOGY OF CANCER NEUROLYSIS

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Single injection neurolysis

Single injection of ethanol for periprostatic neurolysis

Group Type EXPERIMENTAL

Periprostatic neurolysis with dehydrated alcohol (ethanol)

Intervention Type PROCEDURE

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

Two injection neurolysis

Two temporally separated periprostatic ethanol injections

Group Type EXPERIMENTAL

Periprostatic neurolysis with dehydrated alcohol (ethanol)

Intervention Type PROCEDURE

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

No injection control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Periprostatic neurolysis with dehydrated alcohol (ethanol)

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No