Recruiting
Not applicable
Barrigel® PPRT (Post-Prostatectomy Radiation Therapy) Trial
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
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)
| Facility | City | Region | Status |
| 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 |
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