Long Acting Neuraxial Peri-prostatic Block in Cancer

NCT06703437 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: STUDY-22-00221
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (2)

• Dose-Limiting Toxicity (DLT)

  The DLT will be measured in the two week post administration period. The target toxicity rate is assumed as 25% considering immediate post-administration toxicity. This rate will not account for the delayed onset toxicities.

  At week 2

• Maximally Tolerated Dose (MTD)

  The MTD will be defined as the dose at which the isotonic estimate of the toxicity rate is closest to the target toxicity rate of 25%. The MTD will be used as a recommended dose for prospective Phase II study in future

  At week 2

Secondary Outcomes (4)

• Time to biochemical recurrence

  at month 6 and at year 2

• Response Rate

  at week 8

• Tumor immunogenicity

  at week 8

• Degree of neural inhibition

  at week 8

Study Arms (1)

Long-acting neuraxial blockade

EXPERIMENTAL

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

Drug: Dehydrated alcohol; Drug: Lidocaine IV

Interventions

Dehydrated alcohol DRUG

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

Long-acting neuraxial blockade

Lidocaine IV DRUG

By periprostatic injection, 2mL

Long-acting neuraxial blockade

Eligibility Criteria

• Age: 45 Years - 75 Years
• Gender Eligibility Details: Limited to Male with high risk prostate cancer clinical features
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• PSA \>10
• PSAD \>0.15
• PI-RADS 5 lesion on MRI
• Karnofsky performance status \>80
• Ability to understand and the willingness to sign a written informed consent.

You may not qualify if:

• Prior or concomitant treatment for prostate cancer, including radiation therapy, focal therapy, cryo therapy, androgen deprivation therapy.
• Imaging or clinical evidence of metastatic disease.
• PSA \> 100ng/mL

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Study Officials

• Ali Zahalka, MD, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

• Ash Tewari

  Icahn School of Medicine at Mount Sinai

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Instructor

Study Record Dates

• First Submitted: November 21, 2024
• First Posted: November 25, 2024
• Study Start: December 13, 2022
• Primary Completion: February 23, 2023
• Study Completion (Estimated): June 1, 2026
• Last Updated: September 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 9 months and ending 36 months following article publication.
• Access Criteria: Researchers who provide a methodologically sound proposal. To achieve aims in the approved proposal. Proposals should be directed to ali.zahalka@mountsinai.org. To gain access, data requestors need to sign a data access agreement. Proposals may be submitted up to 36 months following article publication. Data will be shared by email.

Locations

US (1)