Actively Recruiting
Two-fraction HDR Monotherapy for Localized Prostate Cancer
Led by University of California, San Francisco · Updated on 2025-04-29
17
Participants Needed
1
Research Sites
233 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a single center single arm prospective pilot study investigating the safety of high dose rate (HDR) brachytherapy as monotherapy delivered in 2 fractions 3 hours apart. HDR monotherapy has been established as safe and effective in this context, however previous studies have delivered 2 fractions on separate days, or at least 6 hours apart. Clinically, this regimen, if shown to be safe and effective in future studies, has the potential to reduce operative resources and logistical stresses on brachytherapy departments.
CONDITIONS
Official Title
Two-fraction HDR Monotherapy for Localized Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed prostate adenocarcinoma diagnosis
- Low to intermediate risk prostate cancer based on National Comprehensive Cancer Network criteria
- No prior treatment for prostate cancer or prior androgen deprivation therapy
- Age 18 years or older
- ECOG performance status less than 2 (Karnofsky greater than 60%)
- Eligible for HDR brachytherapy monotherapy as determined by radiation oncologist
- Ability to understand and sign informed consent
- HIV-infected individuals on effective therapy with undetectable viral load within 6 months
- Chronic hepatitis B infection with undetectable viral load on suppressive therapy if needed
- History of hepatitis C treated and cured or currently on treatment with undetectable viral load
- Prior or concurrent malignancy that does not interfere with safety or efficacy assessment
You will not qualify if you...
- Any prior treatment for prostate cancer
- Any prior androgen deprivation therapy
- Currently receiving other investigational agents
- Abnormal pre-brachytherapy assessment raising safety concerns
- Contraindications to general anesthesia
- Contraindications to radiotherapy
- Prior cryosurgery or cryotherapy to the prostate
- Prior transurethral resection of the prostate within the last 6 months
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of California, San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
Research Team
J
Jamese Johnson
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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