Trial Summary
What is the purpose of this trial?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.
Eligibility Criteria
This trial is for individuals with high-risk prostate cancer features, who are undergoing a prostate biopsy. It's not specified who can't join the trial, but typically those with allergies to the drugs used or certain medical conditions would be excluded.Inclusion Criteria
Ability to understand and the willingness to sign a written informed consent.
PSA >10
PSAD >0.15
+2 more
Exclusion Criteria
I have received treatments for prostate cancer, such as radiation or hormone therapy.
My cancer has spread to other parts of my body.
PSA > 100ng/mL
Participant Groups
The study tests a long-acting block of sympathetic nerves using dehydrated alcohol (>98% Ethanol) and lidocaine during prostate biopsies. This approach aims to halt disease progression by disrupting nerve signals that contribute to cancer growth.
1Treatment groups
Experimental Treatment
Group I: Long-acting neuraxial blockadeExperimental Treatment2 Interventions
Long-acting neuraxial blockade at the time of prostate biopsy by periprostatic injection of Dehydrated alcohol + lidocaine.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Icahn School of Medicine at Mount SinaiNew York, NY
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Who Is Running the Clinical Trial?
Icahn School of Medicine at Mount SinaiLead Sponsor