Actively Recruiting

Phase Not Applicable
Age: 18Years +
MALE
NCT06496256

Barrigel® PPRT (Post-Prostatectomy Radiation Therapy) Trial

Led by Palette Life Sciences, Inc. · Updated on 2025-05-29

84

Participants Needed

5

Research Sites

165 weeks

Total Duration

On this page

Sponsors

P

Palette Life Sciences, Inc.

Lead Sponsor

T

Teleflex

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Barrigel® PPRT (Post-Prostatectomy Radiation Therapy) Trial

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 65 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
Not Eligible

You will not qualify if you...

  • 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
  • History of chronic renal failure
  • History of uncontrolled diabetes (e.g. symptomatic hyperglycemia that is not controlled with medical management; fasting blood glucose >300 mg/dL)
  • History of acquired immunodeficiency syndrome (AIDS). Patients with controlled HIV infection (CD4+ T-cell counts 65 350 cells/�b5L) and no history of AIDS-defining opportunistic infections may be included
  • Contraindication to having an MRI or PSMA/PET scan (e.g. non-MRI compatible device)
  • 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
  • Subject unable or unwilling to comply with study requirements
  • Any condition that in the investigator's opinion would prevent administration or completion of study therapy

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 5 locations

1

Dana Farber Cancer Institute

Boston, Massachusetts, United States, 02215

Actively Recruiting

2

Summit Health

Clifton, New Jersey, United States, 07013

Actively Recruiting

3

Urology Austin

Austin, Texas, United States, 78745

Actively Recruiting

4

Houston Metro Urology

Houston, Texas, United States, 77027

Active, Not Recruiting

5

GenesisCare Ringwood

Melbourne, Victoria, Australia, 3002

Actively Recruiting

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Research Team

J

Joseph Onokwai, MD, MPH, PhD

CONTACT

C

Cliff Kline

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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Barrigel® PPRT (Post-Prostatectomy Radiation Therapy) Trial | DecenTrialz