RecruitingInterventional

Use of Rectal Spacers for Proton Beam Radiation Therapy for Localized Prostate Cancer: Prospective Clinical Study

NCT ID: NCT06594887Sponsor: Princeton ProCure management, LLC.Last updated: 2024-09-19

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.

Arms & 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.

Outcome measures

Primary

Perirectal distance
Perirectal distance evaluated by measurement of the prostate-rectum separation as measured on treatment planning CT simulation.
Time frame: 2-4 months

Secondary

Spacer stability over time
Time frame: 2-4 months
Mean rectal dose
Time frame: 2-4 months

Eligibility criteria

Sex: MaleAge: 18 Years and olderHealthy 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.

Study locations (1)

Procure Proton Therapy Center

Somerset, New Jersey, 08873

Recruiting

Heba Darwish · Contact

heba.darwish@procure.com