Rectal Spacers Use in Prostate Cancer Radiation Therapy

Not Applicable

Recruiting

• Conditions: Prostate Cancer
• Interventions: Device: SpaceOAR Vue; Device: BioProtect Balloon Implant System

• Registration Number: NCT06594887
• Lead Sponsor: Princeton ProCure management, LLC.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-26
• Study Start: 2024-09-06
• Study First Submitted QC: 2024-09-10
• Last Update Submitted: 2024-09-10
• Study First Posted: 2024-09-13
• Last Update Posted: 2024-09-13
• Primary Completion: 2025-09
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SpaceOAR Vue	SpaceOAR Vue	-
BioProtect Balloon Implant System	BioProtect Balloon Implant System	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Procure Proton Therapy Center; 🇺🇸 Somerset, New Jersey, United States