Rectal Spacers in Prostate Cancer Patients Undergoing Radiation Therapy

NCT ID: NCT06599476

Last Updated: 2025-05-22

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-21
• Study Completion Date: 2025-12-31

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

BioProtect Balloon Implant™ System

Intervention Type: DEVICE

The BioProtect Balloon Implant System is intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer, and by creating this space, to reduce the radiation dose delivered to the anterior rectum. The balloon is inserted into the perirectal space and inflated to its pre-defined size. The Balloon is made of biodegradable materials that maintain the space for the entire course of prostate radiation treatment and are absorbed by the patient's body over time

Interventions

BioProtect Balloon Implant™ System

The BioProtect Balloon Implant System is intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer, and by creating this space, to reduce the radiation dose delivered to the anterior rectum. The balloon is inserted into the perirectal space and inflated to its pre-defined size. The Balloon is made of biodegradable materials that maintain the space for the entire course of prostate radiation treatment and are absorbed by the patient's body over time

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Advanced Radiation Centers of New York

OTHER

Sponsor Role: lead

Responsible Party

Shawn Zimberg, MD

Dr Shawn Zimberg, Radiation Oncology Medical Director, Radiation Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Advanced Radiation Centers of New York

New Hyde Park, New York, United States

Countries

United States

Other Identifiers

1372621

Identifier Type: -

Identifier Source: org_study_id