Barrigel® PPRT (Post-Prostatectomy Radiation Therapy) Trial
NCT ID: NCT06496256
Last Updated: 2025-05-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
84 participants
INTERVENTIONAL
2024-10-31
2027-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Treatment Arms
Subjects will be injected Barrigel between the rectum and prostate bed using transrectal ultrasound for guidance.
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
Control Arm
Subjects randomized to the control group will not receive Barrigel but will have a Transrectal ultrasound probe inserted to simulate that aspect of the injection of Barrigel.
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
MALE
No
Sponsors
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Teleflex
INDUSTRY
Palette Life Sciences, Inc.
INDUSTRY
Responsible Party
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Locations
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Dana Farber Cancer Institute
Boston, Massachusetts, United States
Summit Health
Clifton, New Jersey, United States
Urology Austin
Austin, Texas, United States
Houston Metro Urology
Houston, Texas, United States
GenesisCare Ringwood
Melbourne, Victoria, Australia
Countries
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Central Contacts
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Facility Contacts
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Martin King, MD
Role: primary
Role: backup
Other Identifiers
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0423-0001
Identifier Type: -
Identifier Source: org_study_id
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