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NCT06599476Active, not recruiting

Rectal Spacers in Prostate Cancer Patients Undergoing Radiation Therapy

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

Source: ClinicalTrials.gov · Last updated 25 Jun 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
150 (estimated)
First submitted
26 Aug 2024
Start date
21 May 2024
Primary completion date
Sept 2027
Lead sponsor
Advanced Radiation Centers of New York
NCT number
NCT06599476

What you commit to

  • Study type: Interventional
  • Planned participants: 150
  • From 21 May 2024 to the primary completion date, Sept 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previously treated localized adenocarcinoma of the prostate.
  • Active Inflammatory bowel disease requiring treatment with steroids.
  • Prior total prostatectomy.

Other illness

  • Metastatic disease.
  • Current urinary tract infection.

Other

  • Acute or chronic prostatitis.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Advanced Radiation Centers of New York
Coordinator of this site? Confirm its status
New Hyde ParkUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.