NCT06496256 · Palette Life Sciences, Inc.
Barrigel® PPRT (Post-Prostatectomy Radiation Therapy) Trial
What this study 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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 ≥ 350 cells/µL) 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
Where
- Boston, Massachusetts
- Clifton, New Jersey
- Austin, Texas
- Houston, Texas
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 29, 2025 · Source of record for eligibility and locations