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Long Acting Neuraxial Peri-prostatic Block in Cancer

Mount Sinai Health System logo

Mount Sinai Health System

Status and phase

Active, not recruiting
Phase 1

Conditions

Prostate Cancer

Treatments

Drug: Dehydrated alcohol
Drug: Lidocaine IV

Study type

Interventional

Funder types

Other

Identifiers

NCT06703437
STUDY-22-00221

Details and patient eligibility

About

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.

Enrollment

12 patients

Sex

Male

Ages

45 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

12 participants in 1 patient group

Long-acting neuraxial blockade
Experimental group
Description:
Long-acting neuraxial blockade at the time of prostate biopsy by periprostatic injection of Dehydrated alcohol + lidocaine.
Treatment:
Drug: Lidocaine IV
Drug: Dehydrated alcohol

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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