Barrigel® PPRT (Post-Prostatectomy Radiation Therapy) Trial

Launched by PALETTE LIFE SCIENCES, INC. · Jul 3, 2024

Keywords

ClinConnect Summary

The Barrigel® PPRT Trial is a study looking at a new treatment approach for men who have had surgery for prostate cancer. The goal of this trial is to see if Barrigel, a gel that creates space between the rectum and the prostate area, can help reduce the amount of radiation that the rectum receives during radiation therapy. This could help lower the risk of side effects from radiation treatment, making it easier for patients to tolerate their care.

To participate in this trial, you need to be at least 18 years old and have had a specific type of prostate surgery called a radical prostatectomy, which means the prostate has been fully removed. You also need to have certain health conditions and not have any severe problems like active bleeding disorders or uncontrolled diabetes. If you join the trial, you will receive the Barrigel injection before your radiation therapy, and you’ll be monitored throughout the process. It’s important to know that the trial is not yet recruiting participants, so you will need to wait until it officially begins.

Gender

MALE

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