Barrigel for Prostate Cancer

Recruiting at 4 trial locations

Overseen By Joseph Onokwai, MD, MPH, PhD

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Palette Life Sciences, Inc.

Must not be taking: Steroids

Disqualifiers: Allergy to hyaluronic acid, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 3 months

84 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a treatment called Barrigel, designed to assist people with prostate cancer who have undergone a prostatectomy (surgical removal of the prostate). Barrigel serves as a temporary spacer, moving the rectum away from the prostate area during radiation therapy, potentially reducing unwanted radiation exposure to the rectal area. Participants will either receive Barrigel or join a control group with a simulation procedure. Individuals who have had prostate cancer surgery and plan to undergo radiation therapy, without any cancer spread, might be suitable for this trial. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance radiation therapy outcomes for prostate cancer patients.

Do I need to stop my current medications for the Barrigel trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What prior data suggests that Barrigel is safe for use during radiotherapy for prostate cancer?

Research has shown that Barrigel, a gel used to protect the rectum during prostate cancer treatments, is safe. In one study, doctors placed Barrigel in all patients without any harmful side effects. Patients did not experience negative reactions during the study.

Another study found that Barrigel reduced stomach and digestive issues at 3 and 6 months after treatment compared to not using the gel. This indicates that Barrigel not only aids in treatment but is also manageable for patients.

Overall, these findings suggest that Barrigel is safe and may help lessen unwanted side effects during prostate cancer radiation therapy. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Barrigel for prostate cancer because it offers a unique protective approach. Unlike standard treatments like surgery or radiation, Barrigel is injected to create a physical barrier between the prostate and rectum, aiming to reduce radiation exposure to healthy tissues. This method could potentially minimize side effects often associated with prostate cancer treatments, making it a promising option for improving patients' quality of life.

What evidence suggests that Barrigel is effective for prostate cancer?

Research has shown that Barrigel, which participants in this trial may receive, effectively reduces the amount of radiation reaching the rectum during prostate cancer treatment. This reduction leads to fewer rectal side effects. In one study, patients using Barrigel experienced an average reduction of 85% in radiation to the rectum. Barrigel acts as a spacer, creating a safe gap between the rectum and the prostate, which helps protect the rectum from damage. Evidence consistently shows that Barrigel provides reliable spacing throughout radiation therapy, making it a promising option for reducing unwanted radiation exposure. ^{1 4 5 6 7}

Are You a Good Fit for This Trial?

This trial is for men who've had a successful nerve-sparing prostatectomy to treat prostate cancer without evidence of spread. They must have a PSA level of 0.1 ng/mL or higher and be planning to undergo radiation therapy. Participants need an ECOG performance status of 0 or 1, indicating they are fully active or restricted in physically strenuous activity but can do light work.

Inclusion Criteria

I have had a specific type of prostate surgery.

Prostate specific antigen (PSA) 0.1 ng/mL or higher

Written informed consent for study participation prior to study enrollment

Exclusion Criteria

White blood cell count <4000/uL or >12,000/uL

Serum AST/ALT >2.5 times the institutional upper limit of normal

Creatinine >2.0 mg/dL

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Barrigel injection and undergo radiation therapy

3 months

Regular visits for radiation therapy sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Barrigel

Trial Overview

The Barrigel PPRT Trial is testing the use of Barrigel, which creates space between the rectum and the prostate area during radiotherapy after prostate surgery (prostatectomy). The goal is to reduce radiation exposure to the rectum by using this spacing method along with transrectal ultrasound guidance.

How Is the Trial Designed?

Group I: Treatment Arms Experimental Treatment 2 Interventions

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

Group II: Control Arm Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

Palette Life Sciences, Inc.

Lead Sponsor

Trials

1

Recruited

80+

Teleflex

Industry Sponsor

Trials

24

Recruited

7,400+

Citations

1.

barrigel.com

barrigel.com/hcp/barrigel-proven-safe-and-effective

Clinical Results

Barrigel is proven effective at achieving a clinically significant reduction in radiation dose to the rectum, leading to fewer rectal side effects.

2.

investors.teleflex.com

investors.teleflex.com/news/news-details/2024/New-Data-Presented-at-ASTRO-2024-Further-Demonstrate-the-Safety-and-Efficacy-of-Barrigel-Rectal-Spacer-the-First-and-Only-Sculptable-Hyaluronic-Acid-Rectal-Spacer-in-Patients-Undergoing-Radiation-Therapy-for-Prostate-Cancer1-3/default.aspx

New Data Presented at ASTRO 2024 Further Demonstrate ...

Barrigel™ rectal spacer provides high quality rectal spacing, enabling low dose to the rectum during prostate cancer radiation therapy, ...

3.

jamanetwork.com

jamanetwork.com/journals/jamaoncology/fullarticle/2801296

Hyaluronic Acid Spacer for Hypofractionated Prostate ...

The mean (SD) reduction was 85.0% (20.9%). For the secondary outcome, 4 of 136 patients (2.9%) in the spacer group and 9 of 65 patients (13.8%) ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9734283/

Comprehensive review of hydrogel spacers prior to ...

Hydrogel spacers provide a low morbidity method potentially reducing rectal toxicity following radiation therapy in men with prostate cancer.

5.

practicalradonc.org

practicalradonc.org/article/S1879-8500%2823%2900235-7/fulltext

Barrigel Spacer Injection Technique

Consistent spacing through the course of radiation therapy was observed, and the HA spacer was effective in all patient groups, including ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10891188/

One-year clinical outcomes of MR-guided stereotactic body ...

This prospective study aimed to investigate adaptive magnetic resonance (MR)-guided stereotactic body radiation therapy (MRgSBRT) with rectal spacer for ...

7.

oncpracticemanagement.com

oncpracticemanagement.com/issues/2024/november-2024-vol-14-no-11/data-demonstrate-safety-of-sculptable-hyaluronic-acid-rectal-spacer-in-patients-undergoing-prostate-cancer-treatment

Data Demonstrate Safety of Sculptable Hyaluronic Acid ...

Researchers in that study noted a 100% success rate for Barrigel rectal spacer placement, with no use of saline dissection and no adverse events reported. Mean ...