NCT06594887Active, not recruiting
Rectal Spacers Use in Prostate Cancer Radiation Therapy
Use of Rectal Spacers for Proton Beam Radiation Therapy for Localized Prostate Cancer: Prospective Clinical Study
Source: ClinicalTrials.gov · Last updated 21 Sept 2026
Brief summary (registry, in English)
This prospective, 2-arm clinical trial aims to evaluate the use of rectal spacers in patients with localized prostate cancer scheduled for Proton Beam Therapy (PBT). Up to 50 subjects will be enrolled in this study. Study visits will include screening, spacer placement, treatment planning, end-of-treatment assessment, and follow-up visits at 1, 3, and 6 months.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 26 Aug 2024
- Start date
- 6 Sept 2024
- Primary completion date
- Dec 2026
- Lead sponsor
- Princeton ProCure management, LLC.
- Diseases
- Prostate cancer
- NCT number
- NCT06594887
What you commit to
- Study type: Interventional
- Planned participants: 50
- From 6 Sept 2024 to the primary completion date, Dec 2026
- 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
- Planned Pelvic lymph node radiotherapy.
- Prior local prostate cancer therapy
- Active Inflammatory bowel disease requiring treatment with steroids.
- Prior radical prostatectomy.
Other illness
- Metastatic disease.
- Active urinary tract infection.
- Acute or chronic inflammation or infection of the prostate.
Who the study is looking for
- Subjects greater than 18 years old with prostate cancer
- Subjects must have histologically confirmed adenocarcinoma of the prostate with biopsy taken within 12 months and must be planned to undergo proton beam therapy with rectal spacer
- Subjects must have clinical stage T1-T3 with no posterior extra capsular extension of the prostate cancer
- PSA less than or equal to 20 ng/mL
- Gleason Score less than or equal to 7
- Capacity to comprehend and readiness to sign a written informed consent form
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| ProCure Proton Therapy Center Coordinator of this site? Confirm its status | Somerset | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.