Rectal Spacers in Prostate Cancer Patients Undergoing Radiation Therapy

Running, not enrolling · Not applicable

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT06599476

Run by

Advanced Radiation Centers of New York

People needed

150

Starts

2024-05-21

Expected to finish

2027-12-01

Last updated by the study team

2026-06-25

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Patients with prostate cancer ≥ 18 years of age.
• Patients are in one of the following risk groups:
• T1-T3 prostate cancer with no posterior extra capsular extension
• Gleason score ≤ 7
• Planned for radiation treatment with rectal spacer.
• Ability to understand and the willingness to sign a written informed consent form.

You may not qualify if…

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

Where it is running

• Advanced Radiation Centers of New York — New Hyde Park, New York, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.