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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

PREVENTION

Phase

Trial ID

NCT06496256

Intervention or treatment

DEVICE: Barrigel

DEVICE: Transrectal Ultrasound

Conditions

• Prostate Cancer

Condition: Prostate Cancer
DEVICE: Barrigel and other drugs
Melbourne, Victoria, Australia
Sponsor: Palette Life Sciences, Inc.

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

GenesisCare Ringwood

Research sites nearby

Select from list below to view details:

GenesisCare Ringwood
Melbourne, Victoria, Australia

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/Arm	Intervention/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 Measure	Primary Outcome Description	Primary Outcome Time Frame
Reduction in volume of rectum receiving radiation dose	Investigational 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 Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Grade 2 Toxicities	Test 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 QOL	Evaluate the change in Expanded Prostate Cancer Index Composite (EPIC) Bowel Assessment composite score (from baseline within 3 months after completion of radiation therapy	3 months
Expanded Prostate Cancer Index Composite (EPIC) Urinary QOL	Evaluate the change in Expanded Prostate Cancer Index Composite (EPIC) Urinary Assessment composite score from baseline within 3 months after completion of radiation therapy	3 months

Frequently Asked Questions

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You may be eligible to participate in this trial based on your search.Apply for study

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References

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