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Barrigel® PPRT (Post-Prostatectomy Radiation Therapy) Trial

RecruitingNAAges 18 Years - anyMalePalette Life Sciences, Inc.
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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
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What it tests

  • Barrigel
  • Transrectal Ultrasound
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Where

13 sites
Arizona Clinical Trial
Chandler, United States
Sansum Clinic-Sutter Health
Santa Barbara, United States
Baptist Health South Florida Inc
Boca Raton, United States
Augusta University Research Institute
Augusta, United States
Dana Farber Cancer Institute
Boston, United States
Summit Health
Clifton, United States
University Hospitals Cleveland Medical Center
Cleveland, United States
Thomas Jefferson Health Sidney Kimmel Cancer Center
Philadelphia, United States

…and 5 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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