Actively Recruiting
High-dose Brachytherapy Boost With Stereostatic Body Radiation Therapy to Intermediate or Higher Risk Prostate Cancer
Led by University of Nebraska · Updated on 2025-11-05
53
Participants Needed
1
Research Sites
213 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The objective of this phase I/II trial is to prospectively evaluate the toxicity and therapeutic efficacy of Stereostatic Body Radiation Therapy (SBRT) to prostate and pelvic lymph nodes in combination with high-dose-rate (HDR) brachytherapy to the prostate in patients with localized unfavorable-intermediate risk or higher disease.
CONDITIONS
Official Title
High-dose Brachytherapy Boost With Stereostatic Body Radiation Therapy to Intermediate or Higher Risk Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed diagnosis of local unfavorable intermediate or higher risk prostate cancer as defined by NCCN criteria
- No prior definitive treatment or intervention for prostate cancer
- Estimated life expectancy greater than 10 years
- Negative imaging evaluation for lymph node and distant metastatic disease (abdominopelvic CT, prostate MRI, PSMA PET)
- Negative evaluation for bone metastatic disease (bone scan or PSMA PET)
- At least 15% risk of nodal involvement based on MSKCC pre-prostatectomy nomogram
- Karnofsky performance status score of 80 or higher within 30 days before enrollment
- Age 19 years or older
- Clinically suitable candidate for HDR brachytherapy
- Ability to provide informed consent specific to this study
You will not qualify if you...
- American Urological Association Urinary Symptom Score (AUA score) of 15 or higher
- Prostate volume greater than 75 cc or large relative to pelvic arch width preventing proper applicator placement
- Psychological, familial, sociological, or geographical factors interfering with study compliance
- Contraindications to radiation therapy such as inflammatory bowel disease, connective tissue disorders, or genetic conditions increasing radiation sensitivity
- Medical conditions deemed unsafe by the investigator
- Prior invasive malignancy other than prostate cancer unless disease-free for at least 1 year
- History of rectal surgeries
- Major surgery, open biopsy, or significant injury within 30 days before enrollment
- History of Urolift procedure
- Contraindications to general anesthesia
- Preexisting rectal fistula
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Actively Recruiting
Research Team
H
Heather D Mittelstedt, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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