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Long Acting Neuraxial Peri-prostatic Block in Cancer
Sponsor: Icahn School of Medicine at Mount Sinai
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
Dehydrated alcohol
Long-acting neuraxial blockade at the time of prostate biopsy by periprostatic injection of Dehydrated alcohol.
Lidocaine IV
By periprostatic injection, 2mL
Locations (1)
Icahn School of Medicine at Mount Sinai
New York, New York, United States