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Barrigel® PPRT (Post-Prostatectomy Radiation Therapy) Trial

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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.

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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if 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
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    Eligibility

    Age eligible for study : 18 and older

    Healthy volunteers accepted : No

    Gender eligible for study: Male

    Things to know

    Study dates

    Study start: 2024-08-05

    Primary completion: 2027-12-01

    Study completion finish: 2027-12-31

    study type

    Study type

    PREVENTION

    phase

    Phase

      NA

    trial

    Trial ID

    NCT06496256

    Intervention or treatment

    DEVICE: Barrigel

    DEVICE: Transrectal Ultrasound

    Conditions

    • Prostate Cancer

    Find a site

    Closest Location:

    GenesisCare Ringwood

    Research sites nearby

    Select from list below to view details:

    • GenesisCare Ringwood

      Melbourne, Victoria, Australia

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    Study Plan

    This section provides details of the study plan, including how the study is designed and what the study is measuring.

    How is the study designed?

    Participant Group/ArmIntervention/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
    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

    Primary Outcome MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    Reduction in volume of rectum receiving radiation doseInvestigational 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

    Secondary Outcome MeasureSecondary Outcome DescriptionSecondary Outcome Time Frame
    Grade 2 ToxicitiesTest 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 QOLEvaluate the change in Expanded Prostate Cancer Index Composite (EPIC) Bowel Assessment composite score (from baseline within 3 months after completion of radiation therapy3 months
    Expanded Prostate Cancer Index Composite (EPIC) Urinary QOLEvaluate the change in Expanded Prostate Cancer Index Composite (EPIC) Urinary Assessment composite score from baseline within 3 months after completion of radiation therapy3 months

    Frequently Asked Questions

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    References

    Clinical Trials Gov: Barrigel® PPRT (Post-Prostatectomy Radiation Therapy) Trial

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