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

12 Participants Needed

Trial Summary

What is the purpose of this trial?

Disease progression after definitive therapy for prostate cancer is a major source of morbidity and mortality. Adrenergic/sympathetic innervation of the prostate is essential for prostate cancer progression, and abrogation of these signals by blocking adrenergic innervation halts disease progression. Long-acting neuraxial block of the sympathetic nerves that innervate the pelvis with dehydrated alcohol (\>98% Ethanol) is a safe and effective tool in the treatment of chronic pelvic pain and cancer- induced pelvic pain. Furthermore, ultrasound guided periprostatic neuraxial block at the time of prostate biopsy with short-acting lidocaine is standard of care. Herein the research team proposes to administer a long-acting periprostatic neuraxial block with dehydrated alcohol and lidocaine under trans rectal ultrasound guidance in patients with high-risk clinical features for prostate cancer at the time of prostate biopsy.

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 data supports the effectiveness of the treatment Long Acting Neuraxial Peri-prostatic Block for prostate cancer?

Research shows that using lidocaine (a numbing medication) for periprostatic nerve block can effectively reduce pain during prostate procedures, suggesting it may help manage pain in prostate cancer treatments as well. ^{1 2 3 4 5}

Is the use of lidocaine for periprostatic nerve block safe in humans?

Research on using lidocaine for periprostatic nerve block during prostate biopsies suggests it is generally safe for pain control in humans. ^{1 5 6 7 8}

How does the Long Acting Neuraxial Peri-prostatic Block treatment for prostate cancer differ from other treatments?

The Long Acting Neuraxial Peri-prostatic Block treatment is unique because it combines alcohol and lidocaine to provide a nerve block specifically targeting the prostate area, potentially offering longer-lasting pain relief compared to standard lidocaine injections used in prostate procedures. ^{1 4 7 9 10}

Research Team

Ash Tewari

Principal Investigator

Icahn School of Medicine at Mount Sinai

Ali Zahalka, MD, PhD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. Turkey pubmed.ncbi.nlm.nih.gov

Retrospective evaluation of the effects of periprostatic local anesthesia on recurrent prostate biopsy. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Local anesthesia for prostate biopsy by periprostatic lidocaine injection: a double-blind placebo controlled study. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Regional anesthesia/analgesia and the risk of cancer recurrence and mortality after prostatectomy: a meta-analysis. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Bupivacaine infiltration into the neurovascular bundle of the prostatic nerve does not improve postoperative pain or recovery following transvesical prostatectomy. [2019]

5. Brazil pubmed.ncbi.nlm.nih.gov

Is the periprostatic anesthetic blockade advantageous in ultrasound-guided prostate biopsy? [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Randomized prospective study of periprostatic local anesthesia during transrectal ultrasound-guided prostate biopsy. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Comparison of two periprostatic nerve blockade techniques for transrectal ultrasound-guided prostate biopsy: bilateral basal injection and single apical injection. [2016]

8. Italy pubmed.ncbi.nlm.nih.gov

The effectivity of periprostatic nerve blockade for the pain control during transrectal ultrasound guided prostate biopsy. [2022]

9. Turkey pubmed.ncbi.nlm.nih.gov

Comparison of two different doses of lidocaine on the pain sensation during transrectal ultrasound-guided prostate biopsy. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Transrectal periprostatic lidocaine injection anesthesia for transrectal prostate biopsy: a prospective study. [2022]