Rectal Spacers Use in Prostate Cancer Radiation Therapy
Conditions
Prostate CancerSummary
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.
Locations
1 location Found with status Recruiting
Eligibility Criteria
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.
Study Plan
SpaceOAR Vue
DEVICE:
SpaceOAR VueDescription:
Peri-rectal hydrogel spacer consists of a layer of polyethylene-glycol gel (SpaceOAR vue) in order to outdistance the prostate from anterior rectal wall
BioProtect Balloon Implant System
DEVICE:
BioProtect Balloon Implant SystemDescription:
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.
Outcome Measures
Primary Outcome Measures
Perirectal distance
Secondary Outcome Measures
Spacer stability over time
Mean rectal dose
Timeline
Last Updated
September 19, 2024Start Date
September 19, 2024Today
January 16, 2025Completion Date ( Estimated )
December 1, 2025
Sponsors of this trial
Lead Sponsor
Princeton ProCure management, LLC.