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Barrigel® PPRT (Post-Prostatectomy Radiation Therapy) Trial
NCT06496256 · Palette Life Sciences, Inc.
In plain English
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Official title
Randomized Trial of Barrigel® to Increase Distance Between the Rectum and Prostate Bed to Decrease Rectal Dose in Patients Receiving Moderately Hypofractionated Radiation Therapy Who Have Had Recurrence of Prostate Cancer After Prostatectomy
About this study
Barrigel is composed of biodegradable material and maintains space for the entire course of prostate or prostate bed radiotherapy and is intended to be absorbed by the patient's body over time.
To evaluate the safety and effectiveness of Barrigel to reduce the radiation dose delivered to the anterior rectum by creating a space when injected between the rectum and the prostate bed in men receiving definitive external beam radiation therapy (intensity-modulated radiation therapy) for recurrence of prostate cancer after radical prostatectomy.
A prospective, randomized, controlled, single-masked multicenter study.
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
Study design
Enrollment target: 84 participants
Allocation: randomized
Masking: single
Age groups: adult, older_adult
Timeline
Starts: 2024-10-31
Estimated completion: 2027-12-31
Last updated: 2025-05-29
Interventions
Device: BarrigelDevice: Transrectal Ultrasound
Primary outcomes
- • Reduction in volume of rectum receiving radiation dose (3 months)
Sponsor
Palette Life Sciences, Inc. · industry
With: Teleflex
Contacts & investigators
ContactJoseph Onokwai, MD, MPH, PhD · contact · v-jonokwai@palettelifesciences.com · 7738864397
ContactCliff Kline · contact · cliff.kline@teleflex.com · 8054569653
All locations (5)
Dana Farber Cancer InstituteRecruiting
Boston, Massachusetts, United States
Summit HealthRecruiting
Clifton, New Jersey, United States
Urology AustinRecruiting
Austin, Texas, United States
Houston Metro UrologyActive Not Recruiting
Houston, Texas, United States
GenesisCare RingwoodRecruiting
Melbourne, Victoria, Australia