Long Acting Neuraxial Peri-prostatic Block in Cancer

NCT ID: NCT06703437

Last Updated: 2025-09-03

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-13
• Study Completion Date: 2026-06-01

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Long-acting neuraxial blockade

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

Group Type: EXPERIMENTAL

Dehydrated alcohol

Intervention Type: DRUG

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

Lidocaine IV

Intervention Type: DRUG

By periprostatic injection, 2mL

Interventions

Dehydrated alcohol

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

Intervention Type: DRUG

Lidocaine IV

By periprostatic injection, 2mL

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

Ali Zahalka

Clinical Instructor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ali Zahalka, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Ash Tewari

Role: STUDY_DIRECTOR

Icahn School of Medicine at Mount Sinai

Locations

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Countries

United States

Other Identifiers

STUDY-22-00221

Identifier Type: -

Identifier Source: org_study_id