Rectal Spacers in Prostate Cancer Patients Undergoing Radiation Therapy

Advanced Radiation Centers of New York

Status: Active, not recruiting

Conditions: Prostate Cancer

Treatments: Device: BioProtect Balloon Implant™ System

Study type: Interventional

Funder types: Other

Identifiers

NCT06599476

1372621

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 1 patient group

BioProtect Balloon Implant System

Experimental group

Description:

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

Treatment:

Device: BioProtect Balloon Implant™ System