Prostate Cancer
Conditions
Brief summary
This prospective, 2-arm clinical trial aims to evaluate the use of rectal spacers in patients with localized prostate cancer scheduled for Proton Beam Therapy (PBT). Up to 50 subjects will be enrolled in this study. Study visits will include screening, spacer placement, treatment planning, end-of-treatment assessment, and follow-up visits at 1, 3, and 6 months.
Interventions
DEVICESpaceOAR Vue
Peri-rectal hydrogel spacer consists of a layer of polyethylene-glycol gel (SpaceOAR vue) in order to outdistance the prostate from anterior rectal wall
DEVICEBioProtect Balloon Implant System
The balloon spacer is a biodegradable balloon made of poly (L-Lactide-co-caprolactone) which is a co-polymer of Poly Lactide acid and epsilon Caprolactone (BioProtect Balloon Implant System, BioProtect Ltd) inflated with saline, providing around 18 mm space height , and can be deflated and repositioned if needed, both laterally and along the distal /proximal planes, for optimal uniformity of spacing.
Sponsors
Princeton ProCure management, LLC.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subjects greater than 18 years old with prostate cancer 2. Subjects must have histologically confirmed adenocarcinoma of the prostate with biopsy taken within 12 months and must be planned to undergo proton beam therapy with rectal spacer 3. Subjects must have clinical stage T1-T3 with no posterior extra capsular extension of the prostate cancer 4. PSA less than or equal to 20 ng/mL 5. Gleason Score less than or equal to 7 6. Capacity to comprehend and readiness to sign a written informed consent form
Exclusion criteria
1. Planned Pelvic lymph node radiotherapy. 2. Metastatic disease. 3. Prior local prostate cancer therapy 4. Active Inflammatory bowel disease requiring treatment with steroids. 5. Prior radical prostatectomy. 6. Active urinary tract infection. 7. Acute or chronic inflammation or infection of the prostate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Perirectal distance | 2-4 months | Perirectal distance evaluated by measurement of the prostate-rectum separation as measured on treatment planning CT simulation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Spacer stability over time | 2-4 months | Evaluated by spacer's height (mm) measurements taken at the last radiation treatment day. |
| Mean rectal dose | 2-4 months | Spacers effect on the exposure of the rectum to radiation (rV 70) |
Countries
United States
Contacts
Primary ContactEdward Soffen, MD
Backup ContactHeba Darwish
Outcome results
None listed