Rectal Spacers in Prostate Cancer Patients Undergoing Radiation Therapy

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

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.

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.