Status:
ACTIVE_NOT_RECRUITING
Rectal Spacers in Prostate Cancer Patients Undergoing Radiation Therapy
Lead Sponsor:
Advanced Radiation Centers of New York
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
NA
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 tria...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
May 21 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06599476
Start Date
May 21 2024
End Date
December 1 2025
Last Update
May 22 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Advanced Radiation Centers of New York
New Hyde Park, New York, United States, 11042