This phase Ib trial compares the effect of inhibiting nerve activity to the prostate with 1 injection of ethanol to 2 injections in treating patients with high-risk prostate cancer that has not spread to other parts of the body (localized). Prostate cancer has been shown to invade nerves, a mechanism that is thought to be involved in tumor progression and spread in men with high-risk cancer. Targeting the nerves that supply the prostate prior to surgery may reduce tumor aggressiveness and prevent or delay it from returning after surgery. Ethanol, a type of alcohol, may numb the nerves to the prostate for several months which may reduce the nerves and slow or stop the spread of the tumor. This trial may help researchers learn whether 1 or 2 injections of ethanol is more effective in reducing nerves in the prostate and whether it will slow or stop the tumor from spreading patients with high-risk localized prostate cancer.
Additional locations may be listed on ClinicalTrials.gov for NCT07100847.
Locations matching your search criteria
United States
Texas
Dallas
UT Southwestern/Simmons Cancer Center-DallasStatus: Active
Contact: Ali Zahalka
Phone: 214-648-9419
PRIMARY OBJECTIVE:
I. To determine the optimal number of periprostatic ethanol injections (1 versus [vs] 2) that maximize prostatic denervation on histology.
SECONDARY OBJECTIVES:
I. To describe the adverse events associated with pure ethanol when administered by ultrasound guided periprostatic injection as 1 vs 2 injections.
II. In patients with measurable disease, to describe any preliminary evidence of anti-tumor activity by assessment of objective response as determined by rates of ≥ pT3a on pathology after radical prostatectomy.
III. Assess objective response as measured by the composite endpoint of event-free survival (defined as time from date of prostatectomy to date of biochemical progression, subsequent androgen deprivation therapy [ADT], radiation therapy > 6 months after radical prostatectomy [RP], local or distant progression, or death).
EXPLORATORY OBJECTIVES:
I. To assess the effect of periprostatic neurolysis (1 vs 2 injections) on erectile function and urinary symptoms prior to surgery and at 6 months post-surgery as measured by validated sexual health inventory of men (SHIM) score and the validated American Urological Association (AUA) symptom score questionnaire (International Prognostic Scoring System [IPSS]) score.
II. To assess the effect of periprostatic neurolysis (1 vs 2 injections) on post prostatectomy penile length and fibrosis as determined by stretched penile length and penile physical exam/doppler/elastography.
OUTLINE: Patients are randomized to 1 of 2 groups. Patient who decline intervention are assigned to group 3.
GROUP 1: Patients receive ethanol transrectal injection at time of prostate ultrasound or biopsy on day 1 in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo prostate magnetic resonance imaging (MRI) at screening and blood sample collection throughout the study.
GROUP 2: Patients receive ethanol transrectal injection at time of prostate ultrasound or biopsy on day 1 and again in 1-2 weeks for a total of 2 doses in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo prostate MRI at screening and blood sample collection throughout the study.
Group 3: Patients undergo prostate MRI at screening and blood sample collection throughout the study.
After completion of study treatment, patients are followed up at weeks 1 or 2-3, and weeks 6-8 and at 6 months.
Lead OrganizationUT Southwestern/Simmons Cancer Center-Dallas
Principal InvestigatorAli Zahalka
