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Active, Not Recruiting

NCT Number: NCT06703437

Long Acting Neuraxial Peri-prostatic Block in 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

45 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Icahn School of Medicine at Mount Sinai

New York, 10029, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dehydrated alcohol

Drug

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

Lidocaine IV

Drug

By periprostatic injection, 2mL

Primary outcomes

  1. Dose-Limiting Toxicity (DLT)

    Time frame: At week 2

    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.

  2. Maximally Tolerated Dose (MTD)

    Time frame: At week 2

    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

Secondary outcomes

  1. Time to biochemical recurrence

    Time frame: at month 6 and at year 2

    Absence or presence of any evidence of biochemical recurrence at two years after definitive treatment for prostate cancer.

  2. Response Rate

    Time frame: at week 8

    Evidence of response supported by either histologic markers of treatment response, evidence based on difference in molecular proliferation markers between PBx and prostatectomy specimen.

  3. Tumor immunogenicity

    Time frame: at week 8

    Evidence based on tumor immunogenicity as measured by PD1/PDL-1 expression by immunohistochemistry on final pathology.

  4. Degree of neural inhibition

    Time frame: at week 8

    Histological quantification of adrenergic nerve density by tyrosine hydroxylase positive nerve staining

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2026
First posted
Nov 25, 2024
Registry last updated
Sep 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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