NCT06703437

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

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Icahn School of Medicine at Mount Sinai · Academic / Other
• Sex: Male
• Age: 45 Years – 75 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-12-13
• Primary completion: 2023-02-23
• Completion: 2026-06-01
• First posted: 2024-11-25
• Last updated: 2025-09-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study