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ACTIVE NOT RECRUITING
NCT06703437
PHASE1

Long Acting Neuraxial Peri-prostatic Block in Cancer

Sponsor: Icahn School of Medicine at Mount Sinai

View on ClinicalTrials.gov

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.

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

Key Details

Gender

MALE

Age Range

45 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

12

Start Date

2022-12-13

Completion Date

2026-06-01

Last Updated

2025-09-03

Healthy Volunteers

No

Conditions

Interventions

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

Locations (1)

Icahn School of Medicine at Mount Sinai

New York, New York, United States