RecruitingProstate Cancer

Barrigel® PPRT (Post-Prostatectomy Radiation Therapy) Trial

Eligible age

18+ yrs

Accepts

Men

Locations

10 states

Healthy volunteers

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About this study

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.

Sponsor: Palette Life Sciences, Inc.

You may qualify if…

✓ 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

You may not qualify if…

✕ 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