Nerve Block with Alcohol and Lidocaine for Prostate Cancer

Age: 18+

Sex: Male

Trial Phase: Phase 1

Sponsor: Icahn School of Medicine at Mount Sinai

Disqualifiers: Metastatic disease, Prior prostate treatment, others

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

Compensation: Varies

Number of Visits: 3

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to slow prostate cancer by blocking nerve signals that aid its growth. The treatment, Long Acting Neuraxial Peri-prostatic Block, uses a mix of alcohol and lidocaine (a numbing medicine) to target nerves around the prostate during a biopsy. The goal is to determine if this method can prevent cancer from worsening. The trial seeks men with prostate cancer concerns, such as a PSA level over 10 or specific MRI findings. Participants should not have received prior treatments for prostate cancer. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are currently receiving treatment for prostate cancer, you would not be eligible to participate.

What prior data suggests that this method is safe for prostate cancer patients?

Research has shown that using a nerve block with alcohol and lidocaine is generally safe. Studies have found that a long-lasting nerve block with dehydrated alcohol (more than 98% ethanol) effectively treats pelvic pain from cancer. It is also used for ongoing cancer pain and might improve survival in some advanced cancers, indicating it is well-tolerated for these purposes.

Additionally, using a nerve block with lidocaine is common during prostate biopsies. Studies indicate that combining a nerve block with lidocaine gel makes the procedure safer and more comfortable.

As this is still an early-stage study, more research is needed to confirm safety. However, the use of these treatments in other situations provides some confidence in their safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about the long-acting neuraxial peri-prostatic block for prostate cancer because it offers a novel approach to pain management during prostate biopsies. Unlike standard treatments, which typically involve systemic pain relief through oral or injectable analgesics, this method uses a targeted nerve block with dehydrated alcohol and lidocaine directly at the site of the prostate. This precise delivery method could potentially provide more effective and longer-lasting pain relief with fewer systemic side effects. Additionally, by combining dehydrated alcohol and lidocaine, the treatment may offer both immediate and extended pain relief, enhancing patient comfort during the procedure.

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

This trial will evaluate the use of a long-acting neuraxial blockade with a combination of alcohol and lidocaine for prostate cancer. Research has shown that using a mix of alcohol and lidocaine to block nerves around the prostate can be effective. Specifically, studies have found that lidocaine reduces pain during prostate procedures. Alcohol, particularly in a concentrated form, safely blocks the nerves that aid prostate cancer growth. This nerve block method aims to stop the nerve signals that contribute to the progression of prostate cancer. Combining alcohol and lidocaine in a nerve block may offer a promising way to manage prostate cancer symptoms and slow its progression. ^{1 2 4 6 7}

Who Is on the Research Team?

Ali Zahalka, MD, PhD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Ash Tewari

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

This trial is for individuals with high-risk prostate cancer features, who are undergoing a prostate biopsy. It's not specified who can't join the trial, but typically those with allergies to the drugs used or certain medical conditions would be excluded.

Inclusion Criteria

Ability to understand and the willingness to sign a written informed consent.

PSA >10

PSAD >0.15

Exclusion Criteria

I have received treatments for prostate cancer, such as radiation or hormone therapy.

My cancer has spread to other parts of my body.

PSA > 100ng/mL

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Administration of long-acting periprostatic neuraxial block with dehydrated alcohol and lidocaine under transrectal ultrasound guidance at the time of prostate biopsy

2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of dose-limiting toxicity and response rate

8 weeks

2 visits (in-person)

Long-term Follow-up

Monitoring for biochemical recurrence and degree of neural inhibition

2 years

What Are the Treatments Tested in This Trial?

Interventions

• Long Acting Neuraxial Peri-prostatic Block

Trial Overview The study tests a long-acting block of sympathetic nerves using dehydrated alcohol (>98% Ethanol) and lidocaine during prostate biopsies. This approach aims to halt disease progression by disrupting nerve signals that contribute to cancer growth.

How Is the Trial Designed?

Group I: Long-acting neuraxial blockade Experimental Treatment 2 Interventions

Long-acting neuraxial blockade at the time of prostate biopsy by periprostatic injection of Dehydrated alcohol + lidocaine.

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

Citations

1. withpower.com withpower.com/trial/phase-1-prostatic-neoplasms-11-2022-eee64

Nerve Block with Alcohol and Lidocaine for Prostate Cancer Research shows that using lidocaine (a numbing medication) for periprostatic nerve block can effectively reduce pain during prostate procedures, suggesting it ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06429046?term=LIDOCAINE&rank=5

Study Details | NCT06429046 | Effect of Lidocaine Gel and ... In recent studies, local anesthesia is used in transrectal ultrasound-guided prostate biopsies; Methods such as periprostatic nerve block (PPSB), lidocaine ...

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1155/2024/9331738

Lower Dose of 5 mL of 1% Lidocaine is More Suitable than ... Thus, 5 and 10 mL of 1% lidocaine were suggested to be equally effective in blocking the higher-level thoracic-level nerves involved in prostate ...

4. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.5_suppl.391

An open-label phase 1, window-of-opportunity study ... An open-label phase 1, window-of-opportunity study of ultrasound-guided long acting periprostatic neuraxial block with ethanol in patients with high-risk ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8447510/

Efficacy of additional periprostatic apex nerve block on ... This retrospective study collected data from 312 patients who underwent transrectal prostate biopsies between January 2019 and August 2020.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31160805/

Efficacy and safety of periprostatic nerve block combined ... Conclusions: In multiple aspects, a periprostatic nerve block combined with subcutaneous perineal anaesthesia and intrarectal lidocaine gel is a safer and more ...

7. researchgate.net researchgate.net/publication/389115678_An_open-label_phase_1_window-of-opportunity_study_of_ultrasound-guided_long_acting_periprostatic_neuraxial_block_with_ethanol_in_patients_with_high-risk_prostate_cancer

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).