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

Trial Summary

What is the purpose of this trial?

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 Criteria

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

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

Treatment Details

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.

Participant Groups

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+