Barrigel® PPRT (Post-Prostatectomy Radiation Therapy) Trial

NCT06496256 | Recruiting FDA Device

• 1 other identifier: 0423-0001
• Study Type: interventional
• Target: 84
• Locations: 2 countries
• Sites: 5

Brief 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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Grade 2 Toxicities

  3 Months

• Expanded Prostate Cancer Index Composite (EPIC) bowel QOL

  3 months

• Expanded Prostate Cancer Index Composite (EPIC) Urinary QOL

  3 months

Other Outcomes (1)

• Adverse Events

  3 months

Study Arms (2)

Treatment Arms

EXPERIMENTAL

Subjects will be injected Barrigel between the rectum and prostate bed using transrectal ultrasound for guidance.

Device: Barrigel; Device: Transrectal Ultrasound

Control Arm

SHAM COMPARATOR

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

Interventions

Barrigel DEVICE

Barrigel is an absorbable gel based on Non-Animal Stabilized Hyaluronic Acid (NASHA™) that is injected into the peri-rectal space

Treatment Arms

Transrectal Ultrasound DEVICE

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; Treatment Arms

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Prostatectomy surgeon notes specifying successful bilateral nerve Sparing procedure
• Documentation of an intra or interfascial radical prostatectomy
• Confirmed diagnosis of adenocarcinoma of the prostate treated primarily with radical prostatectomy with pN0 or pNX pathologic stage
• No radiographic evidence of local, regional, or distant metastatic disease via PSMA PET or Axumin fluciclovine F18 scan
• Prostate specific antigen (PSA) 0.1 ng/mL or higher
• Intent to receive definitive radiation therapy to the prostate bed
• Written informed consent for study participation prior to study enrollment

You may not qualify if:

• Known allergy to hyaluronic acid
• Pathologic T4 disease
• Prior local prostate cancer therapy including cryotherapy or brachytherapy.
• Prior post-prostatectomy or pelvic radiation therapy
• Planned elective pelvic lymph node radiation therapy
• Prior anorectal surgery (e.g. low anterior resection, abdominoperineal resection, absence of a rectum)
• Inflammatory bowel disease requiring treatment with steroids (e.g. Crohn's disease, ulcerative colitis)
• Active connective tissue disorder including lupus or scleroderma
• Any urogenital abnormality that could limit the ability to access the Barrigel injection site
• White blood cell count \<4000/uL or \>12,000/uL.
• Hemoglobin \<10 g/dL (transfusion or other intervention to achieve this is acceptable).
• Active bleeding disorder or clinically significant coagulopathy defined as PTT \>35 seconds or INR \>1.4 or platelet count \<100,000/mm3.
• Serum AST/ALT \>2.5 times the institutional upper limit of normal
• Creatinine \>2.0 mg/dL
• Bilirubin \>2.0 mg/dL

Sponsors & Collaborators

• Palette Life Sciences, Inc.: lead
• Teleflex: collaborator

Study Sites (5)

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

Summit Health

Clifton, New Jersey, 07013, United States

RECRUITING

Urology Austin

Austin, Texas, 78745, United States

RECRUITING

Houston Metro Urology

Houston, Texas, 77027, United States

ACTIVE NOT RECRUITING

GenesisCare Ringwood

Melbourne, Victoria, 3002, Australia

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Ultrasound, High-Intensity Focused, Transrectal

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

High-Intensity Focused Ultrasound Ablation; Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Ablation Techniques; Surgical Procedures, Operative; Prostatectomy; Urologic Surgical Procedures, Male; Urologic Surgical Procedures; Urogenital Surgical Procedures

Central Study Contacts

Joseph Onokwai, MD, MPH, PhD

CONTACT

7738864397; v-jonokwai@palettelifesciences.com

Cliff Kline

CONTACT

8054569653; cliff.kline@teleflex.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: All subjects who sign a consent and meet inclusion and exclusion criteria will be randomized to the treatment or the control arm.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, randomized, controlled, single-blinded multicenter study

Study Record Dates

• First Submitted: July 3, 2024
• First Posted: July 11, 2024
• Study Start: October 31, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: Within three months of the FDA decision.
• Access Criteria: Qualified researchers with the intent to publish their results.

Locations

AU (1); US (4)