Nerve Block for Prostate Cancer

Age: 18+

Sex: Male

Trial Phase: Phase 1

Sponsor: University of Texas Southwestern Medical Center

Disqualifiers: Seminal vesicle, Lymph node, Metastatic, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 to 6 weeks

21 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether blocking nerve activity around the prostate can slow or stop the spread of prostate cancer. Researchers compare the effects of one versus two nerve-blocking injections to determine which is more effective. Men with high-risk prostate cancer who plan to have surgery and have not received prior treatment might be suitable for this trial. Participants will help assess if this nerve-blocking approach, specifically using periprostatic neurolysis with dehydrated alcohol (ethanol), is a promising way to manage prostate cancer. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative approach.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this nerve block technique is safe for prostate cancer patients?

Research has shown that using ethanol to block nerves around the prostate is safe for humans. A previous study found that injecting 5 mL of ethanol was well tolerated, with no side effects reported. Ethanol, a type of alcohol, can numb the nerves near the prostate when injected, potentially slowing or stopping the spread of prostate cancer. The FDA has already approved ethanol injections for managing chronic cancer pain, indicating their general safety for humans. This trial studies the safety of both one and two ethanol injections. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Researchers are excited about using periprostatic neurolysis with dehydrated alcohol for prostate cancer because it offers a different approach compared to standard treatments like surgery, radiation, or hormone therapy. This method involves injecting ethanol directly around the prostate to specifically target nerve pathways that can contribute to cancer pain. By disrupting these nerves, the treatment aims to provide pain relief more directly and potentially with fewer side effects than systemic treatments. Additionally, the trial is exploring both single and multiple injection strategies to optimize effectiveness and patient comfort.

What evidence suggests that this nerve block treatment might be effective for prostate cancer?

Research has shown that stopping nerve activity around the prostate might help slow the spread of prostate cancer. Previous studies found that injecting ethanol (a type of alcohol) into the prostate area can reduce the number of nerves there. This decrease in nerves might limit the cancer's ability to grow and spread. Ethanol injections have also been safely used in other cancer treatments to numb nerves and manage pain. Early results suggest that ethanol can reduce nerve activity for several months, potentially slowing tumor growth. This trial will compare the effectiveness of a single injection versus two temporally separated injections of ethanol for periprostatic neurolysis to determine which approach works better. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

This trial is for men with high-risk prostate cancer features. It's not clear what specific criteria participants must meet or avoid to be eligible, as the provided information does not include detailed inclusion or exclusion criteria.

Inclusion Criteria

I want surgery for my prostate cancer.

I am eligible for major prostate surgery.

I have not received any treatment for prostate cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive one or two injections of ethanol for periprostatic neurolysis

4 to 6 weeks

Follow-up

Participants are monitored for changes in prostate symptoms, sexual health, and penile length

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Periprostatic Neurolysis with Dehydrated Alcohol (Ethanol)

Trial Overview The study tests if blocking nerve activity to the prostate using one or two injections of ethanol can slow down or stop prostate cancer spread. Previous studies suggest this approach might be safe and potentially beneficial in treating cancer.

How Is the Trial Designed?

Group I: Two injection neurolysis Experimental Treatment 1 Intervention

Two temporally separated periprostatic ethanol injections

Group II: Single injection neurolysis Experimental Treatment 1 Intervention

Single injection of ethanol for periprostatic neurolysis

Group III: No injection control Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

American Urological Association

Collaborator

Trials

5

Recruited

640+

Urology Care Foundation

Collaborator

Trials

1

Recruited

50+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07100847

NCT07100847 | Periprostatic Neurolysis in Prostate Cancer The goal of this study is to optimize prostatic denervation by comparing the denervation efficiency of 1 vs 2 periprostatic ethanol injections.

2. patlynk.com patlynk.com/trial/NCT07100847

Peri-prostatic Neurolysis in High-risk Localized ... 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 ...

3. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2025-07169

Inhibiting Nerve Activity with Ethanol for the Treatment of ... Ethanol, a type of alcohol, may numb the nerves to the prostate for several months which may reduce the nerves and slow or stop the spread of the tumor. This ...

4. clinicaltrials.utswmed.org clinicaltrials.utswmed.org/studies?action=index&controller=studies&search%5Badults%5D=1

UTSW - Study Finder 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 ...

5. asco.org asco.org/abstracts-presentations/ABSTRACT479784

An open-label phase 1, window-of-opportunity study ... Pure Ethanol (>99%) injection for neurolysis is FDA-approved in chronic cancer pain and may have a survival benefit in late-stage cancers (PMC1242819).