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Trial Title:
Barrigel® PPRT (Post-Prostatectomy Radiation Therapy) Trial
NCT ID:
NCT06496256
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Prospective, randomized, controlled, single-blinded multicenter study
Primary purpose:
Prevention
Masking:
Single (Participant)
Masking description:
All subjects who sign a consent and meet inclusion and exclusion criteria will be
randomized to the treatment or the control arm.
Intervention:
Intervention type:
Device
Intervention name:
Barrigel
Description:
Barrigel is an absorbable gel based on Non-Animal Stabilized Hyaluronic Acid (NASHA™)
that is injected into the peri-rectal space
Arm group label:
Treatment Arms
Intervention type:
Device
Intervention name:
Transrectal Ultrasound
Description:
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
Arm group label:
Control Arm
Arm group label:
Treatment Arms
Summary:
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.
Criteria for eligibility:
Criteria:
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
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
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
GenesisCare Ringwood
Address:
City:
Melbourne
Zip:
3002
Country:
Australia
Start date:
August 5, 2024
Completion date:
December 31, 2027
Lead sponsor:
Agency:
Palette Life Sciences, Inc.
Agency class:
Industry
Collaborator:
Agency:
Teleflex
Agency class:
Industry
Source:
Palette Life Sciences, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06496256