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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06496256




Registration number
NCT06496256
Ethics application status
Date submitted
3/07/2024
Date registered
11/07/2024

Titles & IDs
Public title
Barrigel® PPRT (Post-Prostatectomy Radiation Therapy) Trial
Scientific 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
Secondary ID [1] 0 0
0423-0001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Barrigel
Treatment: Devices - Transrectal Ultrasound

Experimental: Treatment Arms - Subjects will be injected Barrigel between the rectum and prostate bed using transrectal ultrasound for guidance.

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.


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

Treatment: Devices: 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
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Reduction in volume of rectum receiving radiation dose
Timepoint [1] 0 0
3 months
Secondary outcome [1] 0 0
Grade 2 Toxicities
Timepoint [1] 0 0
3 Months
Secondary outcome [2] 0 0
Expanded Prostate Cancer Index Composite (EPIC) bowel QOL
Timepoint [2] 0 0
3 months
Secondary outcome [3] 0 0
Expanded Prostate Cancer Index Composite (EPIC) Urinary QOL
Timepoint [3] 0 0
3 months

Eligibility
Key inclusion criteria
1. Age = 18 years
2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
3. Prostatectomy surgeon notes specifying successful bilateral nerve Sparing procedure
4. Documentation of an intra or interfascial radical prostatectomy
5. Confirmed diagnosis of adenocarcinoma of the prostate treated primarily with radical prostatectomy with pN0 or pNX pathologic stage
6. No radiographic evidence of local, regional, or distant metastatic disease via PSMA PET or Axumin fluciclovine F18 scan
7. Prostate specific antigen (PSA) 0.1 ng/mL or higher
8. Intent to receive definitive radiation therapy to the prostate bed
9. Written informed consent for study participation prior to study enrollment
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
1. Known allergy to hyaluronic acid
2. Pathologic T4 disease
3. Prior local prostate cancer therapy including cryotherapy or brachytherapy.
4. Prior post-prostatectomy or pelvic radiation therapy
5. Planned elective pelvic lymph node radiation therapy
6. Prior anorectal surgery (e.g. low anterior resection, abdominoperineal resection, absence of a rectum)
7. Inflammatory bowel disease requiring treatment with steroids (e.g. Crohn's disease, ulcerative colitis)
8. Active connective tissue disorder including lupus or scleroderma
9. Any urogenital abnormality that could limit the ability to access the Barrigel injection site
10. White blood cell count <4000/uL or >12,000/uL.
11. Hemoglobin <10 g/dL (transfusion or other intervention to achieve this is acceptable).
12. Active bleeding disorder or clinically significant coagulopathy defined as PTT >35 seconds or INR >1.4 or platelet count <100,000/mm3.
13. Serum AST/ALT >2.5 times the institutional upper limit of normal
14. Creatinine >2.0 mg/dL
15. Bilirubin >2.0 mg/dL
16. History of chronic renal failure.
17. History of uncontrolled diabetes (e.g. symptomatic hyperglycemia that is not controlled with medical management; fasting blood glucose >300 mg/dL).
18. 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.
19. Contraindication to having an MRI or PSMA/PET scan (e.g. non-MRI compatible device).
20. 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
21. Subject unable or unwilling to comply with study requirements
22. Any condition that in the investigator's opinion would prevent administration or completion of study therapy

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
5/08/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2027
Actual
Sample size
Target
84
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
GenesisCare Ringwood - Melbourne
Recruitment postcode(s) [1] 0 0
3002 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Palette Life Sciences, Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Teleflex
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Joseph Onokwai, MD, MPH, PhD
Address 0 0
Country 0 0
Phone 0 0
7738864397
Fax 0 0
Email 0 0
v-jonokwai@palettelifesciences.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
Data will be submitted to FDA. Study data may be shared with other researchers for analysis after FDA clearance.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06496256