Rectal Spacers Use in Prostate Cancer Radiation Therapy

Part of paid clinical trials in Somerset, New Jersey.

Sponsor
Princeton ProCure management, LLC.
Study ID
NCT06594887
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SpaceOAR Vue — DEVICE
    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
    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.

Study Details

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.

Key Dates

Start date
Sep 6, 2024
Status verified
Aug 2024
Primary completion
Sep 30, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
50 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: SpaceOAR Vue
  • Experimental: BioProtect Balloon Implant System

Primary Outcome Measure

Perirectal distance [ Time Frame: 2-4 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Procure Proton Therapy CenterSomersetNew Jersey08873
Heba Darwish
[email protected]

Find similar trials in Somerset, NJ

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Procure Proton Therapy Center· Somerset, NJ

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