Using Barrigel to protect the rectum during prostate cancer radiation therapy

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

This study is testing if Barrigel can help protect the rectum during radiation therapy for men with prostate cancer to reduce side effects.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 84 (estimated)
• Ages: 18 Years and up
• Sex: Male
• Sponsor: Palette Life Sciences, Inc. (Industry-sponsored)
• Drugs / interventions: radiation
• Locations: 5 sites (Boston, Massachusetts and 4 other locations)
• Trial ID: NCT06496256 on ClinicalTrials.gov

What this trial studies

This trial evaluates the safety and effectiveness of Barrigel, a biodegradable material, which is injected to create a space between the rectum and the prostate bed during radiation therapy for prostate cancer. By positioning the anterior rectal wall away from the prostate, the study aims to reduce the radiation dose delivered to the rectum, potentially minimizing side effects. The trial is a prospective, randomized, controlled, single-masked multicenter study involving men who have undergone radical prostatectomy and are receiving definitive external beam radiation therapy for prostate cancer recurrence.

Who should consider this trial

Good fit: Ideal candidates are men aged 18 and older who have undergone a successful bilateral nerve-sparing radical prostatectomy and are planning to receive radiation therapy for prostate cancer recurrence.

Not a fit: Patients with known allergies to hyaluronic acid or those who have had prior local prostate cancer therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce radiation exposure to the rectum, potentially lowering the risk of side effects for patients undergoing treatment for prostate cancer.

How similar studies have performed: While the use of biodegradable materials in radiation therapy is an emerging field, this specific application of Barrigel has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

1. Age ≥ 18 years
2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
3. Prostatectomy surgeon notes specifying successful bilateral nerve Sparing procedure
4. Documentation of an intra or interfascial radical prostatectomy
5. Confirmed diagnosis of adenocarcinoma of the prostate treated primarily with radical prostatectomy with pN0 or pNX pathologic stage
6. No radiographic evidence of local, regional, or distant metastatic disease via PSMA PET or Axumin fluciclovine F18 scan
7. Prostate specific antigen (PSA) 0.1 ng/mL or higher
8. Intent to receive definitive radiation therapy to the prostate bed
9. Written informed consent for study participation prior to study enrollment

Exclusion Criteria:

1. Known allergy to hyaluronic acid
2. Pathologic T4 disease
3. Prior local prostate cancer therapy including cryotherapy or brachytherapy.
4. Prior post-prostatectomy or pelvic radiation therapy
5. Planned elective pelvic lymph node radiation therapy
6. Prior anorectal surgery (e.g. low anterior resection, abdominoperineal resection, absence of a rectum)
7. Inflammatory bowel disease requiring treatment with steroids (e.g. Crohn's disease, ulcerative colitis)
8. Active connective tissue disorder including lupus or scleroderma
9. Any urogenital abnormality that could limit the ability to access the Barrigel injection site
10. White blood cell count \<4000/uL or \>12,000/uL.
11. Hemoglobin \<10 g/dL (transfusion or other intervention to achieve this is acceptable).
12. Active bleeding disorder or clinically significant coagulopathy defined as PTT \>35 seconds or INR \>1.4 or platelet count \<100,000/mm3.
13. Serum AST/ALT \>2.5 times the institutional upper limit of normal
14. Creatinine \>2.0 mg/dL
15. Bilirubin \>2.0 mg/dL
16. History of chronic renal failure.
17. History of uncontrolled diabetes (e.g. symptomatic hyperglycemia that is not controlled with medical management; fasting blood glucose \>300 mg/dL).
18. History of acquired immunodeficiency syndrome (AIDS). Patients with controlled HIV infection (CD4+ T-cell counts ≥ 350 cells/µL) and no history of AIDS-defining opportunistic infections may be included.
19. Contraindication to having an MRI or PSMA/PET scan (e.g. non-MRI compatible device).
20. Presence of bilateral hip implants, although unilateral hip implant may be permissible if the implant is MRI compatible and does not produce artifact that interferes with any requirements of the study protocol
21. Subject unable or unwilling to comply with study requirements
22. Any condition that in the investigator's opinion would prevent administration or completion of study therapy

Where this trial is running

Boston, Massachusetts and 4 other locations

• Dana Farber Cancer Institute — Boston, Massachusetts, United States (Recruiting)
• Summit Health — Clifton, New Jersey, United States (Recruiting)
• Urology Austin — Austin, Texas, United States (Recruiting)
• Houston Metro Urology — Houston, Texas, United States (Active_not_recruiting)
• GenesisCare Ringwood — Melbourne, Victoria, Australia (Recruiting)

Study contacts

• Study coordinator: Joseph Onokwai, MD, MPH, PhD

Conditions Prostate Cancer