Rectal Spacers in Prostate Cancer Patients Undergoing Radiation Therapy

Not Applicable

Active, not recruiting

• Conditions: Prostate Cancer
• Interventions: Device: BioProtect Balloon Implant™ System

• Registration Number: NCT06599476
• Lead Sponsor: Advanced Radiation Centers of New York

Brief Summary

This is a prospective clinical study involving up to 150 subjects with localized prostate cancer who are scheduled for radiation treatment with rectal spacer placement.

The goal of this clinical trial is to assess the safety and efficacy of perirectal spacers in patients undergoing radiation therapy for the treatment of localized prostate cancer.

Study visits:

* Screening

* Spacer placement

* Treatment planning simulation

* End of the radiation treatment

* 1,3,and 6-months FU visits.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-21
• Status Verified: 2024-08
• Study First Submitted: 2024-08-26
• Study First Submitted QC: 2024-09-13
• Study First Posted: 2024-09-19
• Last Update Submitted: 2025-05-19
• Last Update Posted: 2025-05-22
• Primary Completion: 2025-08
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 150

Inclusion Criteria

1. Patients with prostate cancer ≥ 18 years of age.

2. Patients are in one of the following risk groups:

   • T1-T3 prostate cancer with no posterior extra capsular extension
   • Gleason score ≤ 7

3. Planned for radiation treatment with rectal spacer.

4. Ability to understand and the willingness to sign a written informed consent form.

Exclusion Criteria

1. Metastatic disease.
2. Previously treated localized adenocarcinoma of the prostate.
3. Active Inflammatory bowel disease requiring treatment with steroids.
4. Prior total prostatectomy.
5. Current urinary tract infection.
6. Acute or chronic prostatitis.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BioProtect Balloon Implant System	BioProtect Balloon Implant™ System	The Bio Protect Balloon Implant System (BioProtectLtd.,TzurYigal,Israel) is an Food and Drug Administration approved rectal spacer that consists of a solid biodegradable balloon-shaped material composed of poly L-Lactide-co-caprolactone

Primary Outcome Measures

Name	Time	Method
Dosimetry	6 months	Dose-volume histogram (DVH) including the percent of the rectal volume receiving 70 Gy

Trial Locations

Locations (1)

Advanced Radiation Centers of New York; 🇺🇸 New Hyde Park, New York, United States