Barrigel® PPRT (Post-Prostatectomy Radiation Therapy) Trial (NCT06496256)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (9 items) and avoid the listed exclusions (23 items).
Location: Dana Farber Cancer Institute — Boston, Massachusetts
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Known allergy to hyaluronic acid
- Pathologic T4 disease
- Prior local prostate cancer therapy including cryotherapy or brachytherapy.
- Prior post-prostatectomy or pelvic radiation therapy
- Planned elective pelvic lymph node radiation therapy
- Prior anorectal surgery (e.g. low anterior resection, abdominoperineal resection, absence of a rectum)
- Inflammatory bowel disease requiring treatment with steroids (e.g. Crohn's disease, ulcerative colitis)
- Active connective tissue disorder including lupus or scleroderma
- Any urogenital abnormality that could limit the ability to access the Barrigel injection site
- White blood cell count \<4000/uL or \>12,000/uL.
- Hemoglobin \<10 g/dL (transfusion or other intervention to achieve this is acceptable).
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (5 Sites)
- Dana Farber Cancer Institute — Boston, Massachusetts
- Summit Health — Clifton, New Jersey
- Urology Austin — Austin, Texas
- Houston Metro Urology — Houston, Texas
- GenesisCare Ringwood — Melbourne, Victoria
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.