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Rectal Spacers Use in Prostate Cancer Radiation Therapy

NCT06594887 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-09-19

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

SpaceOAR 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

DEVICE

BioProtect 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 & Collaborators

  • Princeton ProCure management, LLC.

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-06
Primary Completion
2025-09-30
Completion
2025-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06594887 on ClinicalTrials.gov