Prostate Cancer
Conditions
Brief 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.
Interventions
DEVICEBarrigel
Barrigel is an absorbable gel based on Non-Animal Stabilized Hyaluronic Acid (NASHA™) that is injected into the peri-rectal space
DEVICETransrectal 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
Sponsors
Teleflex
Palette Life Sciences, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
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 model description
Prospective, randomized, controlled, single-blinded multicenter study
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in volume of rectum receiving radiation dose | 3 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Grade 2 Toxicities | 3 Months | 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. |
| Expanded Prostate Cancer Index Composite (EPIC) bowel QOL | 3 months | Evaluate the change in Expanded Prostate Cancer Index Composite (EPIC) Bowel Assessment composite score (from baseline within 3 months after completion of radiation therapy. The EPIC is graded on a 12 point scale, with a higher score indicating a higher outcome. |
| Expanded Prostate Cancer Index Composite (EPIC) Urinary QOL | 3 months | Evaluate the change in Expanded Prostate Cancer Index Composite (EPIC) Urinary Assessment composite score from baseline within 3 months after completion of radiation therapy. The EPIC is graded on a 12 point scale, with a higher score indicating a higher outcome. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | 3 months | All adverse events |
Countries
Australia, United States
Contacts
Primary ContactJoseph Onokwai, MD, MPH, PhD
Backup ContactCliff Kline
Outcome results
None listed