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New treatment option for Prostate Cancer
Official title Barrigel® PPRT (Post-Prostatectomy Radiation Therapy) Trial
ClinicalTrials.gov ID: NCT06496256
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join 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
You likely can't join 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)
See the full eligibility 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
- 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 \ 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
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
- Clifton, New Jersey, United States
- Austin, Texas, United States
- Houston, Texas, United States
- Melbourne, Victoria, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States; Clifton, New Jersey, United States; Austin, Texas, United States; Houston, Texas, United States; Melbourne, Victoria, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.