Long Acting Neuraxial Peri-prostatic Block in Cancer

Phase 1

Active, not recruiting

• Conditions: Prostate Cancer
• Interventions: Drug: Dehydrated alcohol; Drug: Lidocaine IV

• Registration Number: NCT06703437
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-13
• Primary Completion: 2023-05-30
• Status Verified: 2024-11
• Study First Submitted: 2024-11-21
• Study First Submitted QC: 2024-11-21
• Last Update Submitted: 2024-11-21
• Study First Posted: 2024-11-25
• Last Update Posted: 2024-11-25
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Long-acting neuraxial blockade	Lidocaine IV	Long-acting neuraxial blockade at the time of prostate biopsy by periprostatic injection of Dehydrated alcohol + lidocaine.
Long-acting neuraxial blockade	Dehydrated alcohol	Long-acting neuraxial blockade at the time of prostate biopsy by periprostatic injection of Dehydrated alcohol + lidocaine.

Primary Outcome Measures

Name	Time	Method
Dose-Limiting Toxicity (DLT)	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.
Maximally Tolerated Dose (MTD)	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 Outcome Measures

Name	Time	Method
Time to biochemical recurrence	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.
Response Rate	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.
Tumor immunogenicity	at week 8	Evidence based on tumor immunogenicity as measured by PD1/PDL-1 expression by immunohistochemistry on final pathology.
Degree of neural inhibition	at week 8	Histological quantification of adrenergic nerve density by tyrosine hydroxylase positive nerve staining

Trial Locations

Locations (1)

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States