Recruiting

Barrigel® for Reducing Rectal Radiation in Prostate Cancer Recurrence

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Study Aim

This study aims to assess whether Barrigel can effectively reduce the amount of radiation received by the rectum in men undergoing treatment for recurring prostate cancer.

What is being tested

Barrigel

+ Transrectal Ultrasound

Device
Who is being recruted

Urogenital Diseases+7

+ Genital Diseases

+ Genital Diseases, Male

Over 18 Years
+31 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Placebo-Controlled
Interventional
Study Start: October 2024
See protocol details

Summary

Principal SponsorPalette Life Sciences, Inc.
Study ContactJoseph Onokwai, MD, MPH, PhDMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 31, 2024

Actual date on which the first participant was enrolled.

This clinical trial is designed to evaluate a product called Barrigel, which is made from a biodegradable material. The main goal is to determine if Barrigel can safely and effectively reduce the amount of radiation that reaches the rectum in men who are undergoing radiation therapy for prostate cancer that has returned after surgery. By creating more space between the rectum and the area where the prostate used to be, it is hoped that Barrigel can help protect the rectum from radiation damage, potentially leading to fewer side effects and better outcomes for patients. Participants in the study will receive injections of Barrigel to create a space between the rectum and the prostate bed before they begin their radiation treatment. The study involves multiple centers and is designed so neither the participants nor those assessing the outcomes know who receives the Barrigel injection. The study will look at whether this method effectively reduces radiation exposure to the rectum, while also monitoring for any safety concerns. The ultimate aim is to see if using Barrigel can provide a safer radiation therapy experience for patients with recurrent prostate cancer.

Official TitleRandomized 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
NCT06496256
Principal SponsorPalette Life Sciences, Inc.
Study ContactJoseph Onokwai, MD, MPH, PhDMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

84 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Male

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesGenital Diseases, MaleGenital Neoplasms, MaleNeoplasmsNeoplasms by SiteProstatic DiseasesProstatic NeoplasmsUrogenital NeoplasmsMale Urogenital Diseases

Criteria

9 inclusion criteria required to participate
Age ≥ 18 years

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Prostatectomy surgeon notes specifying successful bilateral nerve Sparing procedure

Documentation of an intra or interfascial radical prostatectomy

Show More Criteria

22 exclusion criteria prevent from participating
Known allergy to hyaluronic acid

Pathologic T4 disease

Prior local prostate cancer therapy including cryotherapy or brachytherapy.

Prior post-prostatectomy or pelvic radiation therapy

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Subjects will be injected Barrigel between the rectum and prostate bed using transrectal ultrasound for guidance.

Group II

Sham
Subjects randomized to the control group will not receive Barrigel but will have a Transrectal ultrasound probe inserted to simulate that aspect of the injection of Barrigel.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 5 locations

Recruiting

Dana Farber Cancer Institute

Boston, United StatesOpen Dana Farber Cancer Institute in Google Maps
Recruiting

Summit Health

Clifton, United States
Recruiting

Urology Austin

Austin, United States
Recruiting

GenesisCare Ringwood

Melbourne, Australia
Recruiting
5 Study Centers