This phase I trial tests the safety and effectiveness of Barrigel for protecting the rectum during cryoablation in patients with prostate cancer that has not spread to other parts of the body (localized). Cryoablation is a common treatment for prostate cancer, but the prostate sits very close to the rectum. Because of this, the rectum can be injured by extreme cold during treatment, especially in more aggressive or repeat procedures and when treating the back of the prostate. Barrigel is a medical device made of a soft gel that doctors inject between the prostate and rectum to create space and help protect the rectum during prostate radiation treatment. Barrigel is approved for use as rectal spacer during prostate radiation therapy, but it has not been approved for use during prostate cryoablation. Barrigel may be safe and effective at protecting the rectum during prostate cryoablation.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07567027.
Locations matching your search criteria
United States
New York
New York
Laura and Isaac Perlmutter Cancer Center at NYU LangoneStatus: Active
Contact: Wei Phin Tan
Phone: 646-825-6325
PRIMARY OBJECTIVE:
I. To assess hyaluronic acid-based gel (Barrigel) thermal stability during cryoablation.
SECONDARY OBJECTIVES:
I. To evaluate the safety of Barrigel placement during prostate cryoablation.
II. To measure the perirectal separation achieved by Barrigel on pre- and post-procedural imaging (ultrasound and magnetic resonance imaging [MRI]).
III. To monitor cryoablation-related adverse events using the Common Terminology Criteria for Adverse Events version 5 (CTCAE v5.0).
IV. To characterize Barrigel persistence and morphology over time on MRI (discretionary at 4 weeks, scheduled at month 6).
V. To assess patient-reported outcomes (PROs), including urinary and sexual function via International Prognostic Scoring System (IPSS) and Sexual Health Inventory for Men (SHIM) questionnaires at baseline and follow-up visits.
VI. To document Barrigel volume utilization and technical aspects of placement.
OUTLINE:
Patients undergo Barrigel placement with transrectal ultrasound guidance prior to cryoablation. Patients also undergo collection of blood samples and multiparametric MRI (mpMRI) throughout the trial. Patients may undergo prostate specific membrane antigen (PSMA) positron emission tomography (PET)/computed tomography (CT) at screening.
After completion of study intervention, patients are followed up at 3 and 6 months.
Lead OrganizationLaura and Isaac Perlmutter Cancer Center at NYU Langone
Principal InvestigatorWei Phin Tan
