Barrigel® PPRT (Post-Prostatectomy Radiation Therapy) Trial

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

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Device: Barrigel; Device: Transrectal Ultrasound

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 84
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Joseph Onokwai, MD, MPH, PhD; Phone Number: 7738864397; Email: v-jonokwai@palettelifesciences.com
• Study Contact Backup: Name: Cliff Kline; Phone Number: 8054569653; Email: cliff.kline@teleflex.com

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia, 3002
      • Recruiting
      • GenesisCare Ringwood
      • Contact: Michelle Starman; Phone Number: +388703388; Email: michelle.starmans@genesiscare.com
      • Principal Investigator: Prof Michael Chao, MD
• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Dana Farber Cancer Institute
      • Contact: Martin King, MD
      • Contact: Email: Martin_King@DFCI.HARVARD.EDU
      • Principal Investigator: Martin King, MD
  • New Jersey
    • Clifton, New Jersey, United States, 07013
      • Recruiting
      • Summit Health
      • Contact: Kelly Ritter; Phone Number: 903-361-0748; Email: KRitter@summithealth.com
      • Contact: Jocelyn Remuska; Email: jremuszka@summithealth.com
      • Principal Investigator: Dr. Glen Gejerman, MD
  • Texas
    • Austin, Texas, United States, 78745
      • Recruiting
      • Urology Austin
      • Principal Investigator: Brian Mazzarella, MD
      • Contact: Jennifer Penshorn, RN; Phone Number: 512-737-9840; Email: jennifer.penshorn@urologyaustin.com
      • Contact: Rebecca Rodriquez; Email: rebecca.rodriguez@urologyaustin.com
    • Houston, Texas, United States, 77027
      • Active, not recruiting
      • Houston Metro Urology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Arms; Subjects will be injected Barrigel between the rectum and prostate bed using transrectal ultrasound for guidance.	Device: Barrigel; Barrigel is an absorbable gel based on Non-Animal Stabilized Hyaluronic Acid (NASHA™) that is injected into the peri-rectal space; Device: 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
Sham Comparator: 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.	Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in volume of rectum receiving radiation dose	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.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Grade 2 Toxicities	Test whether the use of the Barrigel spacer does not increase the incidence of acute grade 2+ GI toxicity within the first 3 months, which will be assessed using the proportion of subjects who have one or more incidences of acute grade 2+ GI toxicity within the first 3 months.	3 Months
Expanded Prostate Cancer Index Composite (EPIC) bowel QOL	Evaluate the change in Expanded Prostate Cancer Index Composite (EPIC) Bowel Assessment composite score (from baseline within 3 months after completion of radiation therapy. The EPIC is graded on a 12 point scale, with a higher score indicating a higher outcome.	3 months
Expanded Prostate Cancer Index Composite (EPIC) Urinary QOL	Evaluate the change in Expanded Prostate Cancer Index Composite (EPIC) Urinary Assessment composite score from baseline within 3 months after completion of radiation therapy. The EPIC is graded on a 12 point scale, with a higher score indicating a higher outcome.	3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	All adverse events	3 months

Collaborators and Investigators

• Sponsor: Palette Life Sciences, Inc.
• Collaborators: Teleflex

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: July 3, 2024
• First Submitted That Met QC Criteria: July 3, 2024
• First Posted (Actual): July 11, 2024

Study Record Updates

• Last Update Posted (Actual): May 29, 2025
• Last Update Submitted That Met QC Criteria: May 22, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 0423-0001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be submitted to FDA as part of a 510(k). Study data will be shared with other researchers for analysis and reporting after FDA clearance, including protocol, SAP, CSR, and raw data.
• IPD Sharing Time Frame: Within three months of the FDA decision.
• IPD Sharing Access Criteria: Qualified researchers with the intent to publish their results.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes