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NCT06703437Active, not recruitingPhase 1

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

Source: ClinicalTrials.gov · Last updated 3 Sept 2025

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
12 (actual)
First submitted
21 Nov 2024
Start date
13 Dec 2022
Primary completion date
23 Feb 2023
Lead sponsor
Icahn School of Medicine at Mount Sinai
NCT number
NCT06703437

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 12
  • From 13 Dec 2022 to the primary completion date, 23 Feb 2023
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior or concomitant treatment for prostate cancer, including radiation therapy, focal therapy, cryo therapy, androgen deprivation therapy.

Other illness

  • Imaging or clinical evidence of metastatic disease.

Other

  • PSA \> 100ng/mL

Who the study is looking for

  • 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.

Age in the registry: 45 years to 75 years · Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Icahn School of Medicine at Mount Sinai
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.