Rectal Spacers in Prostate Cancer Patients Undergoing Radiation Therapy

Use of Rectal Spacers in Prostate Cancer Patients Undergoing Radiation Therapy: a Prospective Clinical Study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06599476

Enrollment

150

Registered

2024-09-19

Start date

2024-05-21

Completion date

2027-12-01

Last updated

2026-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

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, 6, 12, 18 and 24-months FU visits.

Interventions

DEVICEBioProtect 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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Dosimetry	6 months	Dose-volume histogram (DVH) including the percent of the rectal volume receiving 70 Gy

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 26, 2026