Periprostatic Neurolysis in Prostate Cancer

Conditions

• NERVES
• NEUROBIOLOGY OF CANCER
• NEUROLYSIS
• PROSTATE CANCER

Eligibility Criteria

Sex

MALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Periprostatic neurolysis with dehydrated alcohol (ethanol) — PROCEDURE
  Pre-operative ultrasound guided periprostatic neurolysis by injection of dehydrated alcohol

Study Details

The purpose of this research study is to assess whether inhibiting nerve activity to the prostate delays progression of disease in men with high-risk clinical features for prostate cancer. Prostate cancer has been shown to invade nerves, a mechanism that is thought to be involved in prostate cancer spread in men with high-risk cancer. When nerve activity to the prostate is blocked in mice with prostate cancer, prostate cancer growth and spread are inhibited. In a previous study we showed that doing so in humans was safe and may have anticancer therapeutic effect. In this study we will test whether one versus two injections of nerve blocking agent is more effective at reducing nerves in the prostate and whether it will slow/stop spread of prostate cancer after treatment.

Key Dates

Start date

Aug 15, 2025

Status verified

Sep 2025

Primary completion

Aug 31, 2026

Completion

Aug 31, 2028

Study Design

Enrollment

21 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Single injection neurolysis
  Single injection of ethanol for periprostatic neurolysis
• Experimental: Two injection neurolysis
  Two temporally separated periprostatic ethanol injections
• No Intervention: No injection control

Primary Outcome Measure

Peritumoral adrenergic nerve density on final histology [ Time Frame: 4 to 6 weeks after treatment initiation ]

Locations (1)

Find similar trials in Dallas, TX

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