RecruitingNot ApplicableNCT06496256

Barrigel® PPRT (Post-Prostatectomy Radiation Therapy) Trial

Randomized Trial of Barrigel® to Increase Distance Between the Rectum and Prostate Bed to Decrease Rectal Dose in Patients Receiving Moderately Hypofractionated Radiation Therapy Who Have Had Recurrence of Prostate Cancer After Prostatectomy


Sponsor

Palette Life Sciences, Inc.

Enrollment

84 participants

Start Date

Oct 31, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Barrigel is intended to temporarily position the anterior rectal wall away from the prostate or prostate bed during radiotherapy treatment for prostate cancer and, in creating this space, it is the intent of Barrigel to reduce the radiation dose delivered to the anterior rectum.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying whether injecting a biodegradable hydrogel spacer (Barrigel) between the rectum and the remaining prostate tissue before radiation therapy after prostatectomy (post-prostatectomy radiation) can protect rectal tissue and reduce side effects. **You may be eligible if...** - You are 18 or older - You have been treated with a radical prostatectomy (nerve-sparing) for prostate adenocarcinoma - Your prostate-specific antigen (PSA) level is 0.1 ng/mL or higher - There is no evidence of cancer spread beyond the prostate on imaging - You plan to receive post-prostatectomy radiation therapy **You may NOT be eligible if...** - Your prostatectomy was not nerve-sparing - You have evidence of cancer spread to lymph nodes or distant organs - You have had prior radiation to the pelvis - You have conditions that make the gel injection unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEBarrigel

Barrigel is an absorbable gel based on Non-Animal Stabilized Hyaluronic Acid (NASHA™) that is injected into the peri-rectal space

DEVICETransrectal Ultrasound

All subjects will have a transrectal ultrasound (TRUS) conducted. In the control subjects this will act as a sham procedure. For the investigational subjects, the TRUS will be used to visualize the placement of the needle


Locations(5)

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Summit Health

Clifton, New Jersey, United States

Urology Austin

Austin, Texas, United States

Houston Metro Urology

Houston, Texas, United States

GenesisCare Ringwood

Melbourne, Victoria, Australia

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06496256


Related Trials