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Recruiting Not applicable

Barrigel® PPRT (Post-Prostatectomy Radiation Therapy) Trial

NCT06496256 · tracked via the Priya Life Science Australia tracker
Sponsor
Palette Life Sciences, Inc
Phase
Not applicable
Started
2024-10-31
Last updated
2026-09-28

Condition(s) studied

Prostate Cancer

Investigational drug(s) / intervention(s)

BarrigelTransrectal Ultrasound

Barrigel: Barrigel is an absorbable gel based on Non-Animal Stabilized Hyaluronic Acid (NASHA™) that is injected into the peri-rectal space

Transrectal Ultrasound: All subjects will have a transrectal ultrasound (TRUS) conducted. In the control subjects this will act as a sham procedure. For the investigational subjects, the TRUS will be used to visualize the placement of the needle

Study summary

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

Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Reduction in volume of rectum receiving radiation dose — 3 months
    Investigational subjects only: Achievement of a ≥ 25% change in reduction in the volume of rectum receiving 90% of the prescription dose in 70% of the subjects.

Trial sites (13)

FacilityCityRegionStatus
Arizona Clinical Trial Chandler Arizona Active Not Recruiting
Sansum Clinic-Sutter Health Santa Barbara California Active Not Recruiting
Baptist Health South Florida Inc Boca Raton Florida Recruiting
Augusta University Research Institute Augusta Georgia Recruiting
Dana Farber Cancer Institute Boston Massachusetts Recruiting
Summit Health Clifton New Jersey Recruiting
University Hospitals Cleveland Medical Center Cleveland Ohio Recruiting
Thomas Jefferson Health Sidney Kimmel Cancer Center Philadelphia Pennsylvania Active Not Recruiting
Urology Austin Austin Texas Recruiting
Houston Metro Urology Houston Texas Withdrawn
Virginia Urology Center Richmond Virginia Recruiting
St. Vincent Hospital Fitzroy Victoria Not Yet Recruiting
GenesisCare Ringwood Melbourne Victoria Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06496256 on ClinicalTrials.gov ↗ ← All trials in Australia