Rectal Spacers in Prostate Cancer Patients Undergoing Radiation Therapy
- Conditions
- Prostate Cancer
- Registration Number
- NCT06599476
- Lead Sponsor
- Advanced Radiation Centers of New York
- 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,and 6-months FU visits.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Male
- Target Recruitment
- 150
-
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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Dosimetry 6 months Dose-volume histogram (DVH) including the percent of the rectal volume receiving 70 Gy
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Advanced Radiation Centers of New York
🇺🇸New Hyde Park, New York, United States
Advanced Radiation Centers of New York🇺🇸New Hyde Park, New York, United States