Long Acting Neuraxial Peri-prostatic Block in Cancer

A Phase I Open Label Peri-prostatic Neuraxial Block With Lidocaine and Ethanol in High-risk Localized Prostate Cancer

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: Dehydrated alcohol; Drug: Lidocaine IV

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Long-acting neuraxial blockade; Long-acting neuraxial blockade at the time of prostate biopsy by periprostatic injection of Dehydrated alcohol + lidocaine.	Drug: Dehydrated alcohol; Long-acting neuraxial blockade at the time of prostate biopsy by periprostatic injection of Dehydrated alcohol.; Drug: Lidocaine IV; By periprostatic injection, 2mL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to biochemical recurrence	Absence or presence of any evidence of biochemical recurrence at two years after definitive treatment for prostate cancer.	at month 6 and at year 2
Response Rate	Evidence of response supported by either histologic markers of treatment response, evidence based on difference in molecular proliferation markers between PBx and prostatectomy specimen.	at week 8
Tumor immunogenicity	Evidence based on tumor immunogenicity as measured by PD1/PDL-1 expression by immunohistochemistry on final pathology.	at week 8
Degree of neural inhibition	Histological quantification of adrenergic nerve density by tyrosine hydroxylase positive nerve staining	at week 8

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Investigators: Principal Investigator: Ali Zahalka, MD, PhD, Icahn School of Medicine at Mount Sinai; Study Director: Ash Tewari, Icahn School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2022
• Primary Completion (Actual): February 23, 2023
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: November 21, 2024
• First Submitted That Met QC Criteria: November 21, 2024
• First Posted (Actual): November 25, 2024

Study Record Updates

• Last Update Posted (Estimated): September 3, 2025
• Last Update Submitted That Met QC Criteria: August 26, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms; Organic Chemicals; Alcohols; Ethanol
• Other Study ID Numbers: STUDY-22-00221

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication.

IPD Sharing 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.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes