Status:
RECRUITING
Rectal Spacers Use in Prostate Cancer Radiation Therapy
Lead Sponsor:
Princeton ProCure management, LLC.
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
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...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- 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
- Exclusion Criteria
- Planned Pelvic lymph node radiotherapy.
- Metastatic disease.
- Prior local prostate cancer therapy
- Active Inflammatory bowel disease requiring treatment with steroids.
- Prior radical prostatectomy.
- Active urinary tract infection.
- Acute or chronic inflammation or infection of the prostate.
Exclusion
Key Trial Info
Start Date :
September 6 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06594887
Start Date
September 6 2024
End Date
December 1 2025
Last Update
September 19 2024
Active Locations (1)
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1
Procure Proton Therapy Center
Somerset, New Jersey, United States, 08873