Actively Recruiting
Rectal Spacers Use in Prostate Cancer Radiation Therapy
Led by Princeton ProCure management, LLC. · Updated on 2024-09-19
50
Participants Needed
1
Research Sites
64 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Rectal Spacers Use in Prostate Cancer Radiation Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
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.
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
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Trial Site Locations
Total: 1 location
1
Procure Proton Therapy Center
Somerset, New Jersey, United States, 08873
Actively Recruiting
Research Team
E
Edward Soffen, MD
CONTACT
H
Heba Darwish
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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