Barrigel® PPRT (Post-Prostatectomy Radiation Therapy) Trial

Official title

Randomized Trial of Barrigel® to Increase Distance Between the Rectum and Prostate Bed to Decrease Rectal Dose in Patients Receiving Moderately Hypofractionated Radiation Therapy Who Have Had Recurrence of Prostate Cancer After Prostatectomy

Overview

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.

Detailed description

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.

Interventions

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

Primary outcome measures

• Reduction in volume of rectum receiving radiation dose [Time frame: 3 months]

Secondary outcome measures (3)

• Grade 2 Toxicities [Time frame: 3 Months]
• Expanded Prostate Cancer Index Composite (EPIC) bowel QOL [Time frame: 3 months]
• Expanded Prostate Cancer Index Composite (EPIC) Urinary QOL [Time frame: 3 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Prevention

Study locations

United States · 4 centers

• Dana Farber Cancer Institute — Boston
• Summit Health — Clifton
• Urology Austin — Austin
• Houston Metro Urology — Houston

Australia · 1 center

• GenesisCare Ringwood — Melbourne

Identifiers

NCT: NCT06496256 · 0423-0001

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗