Two-fraction HDR Monotherapy for Localized Prostate Cancer
Eligible age
18+ yrs
Accepts
Men
Locations
1 state
Healthy volunteers
No
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About this study
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.
Sponsor: University of California, San Francisco
You may qualify if…
- ✓ 1. Participants must have histologically or cytologically confirmed diagnosis of prostate adenocarcinoma.
- ✓ 2. National Comprehensive Cancer Network favorable intermediate risk stratification, defined as one or more intermediate risk factors such as cT2b - cT2c category, grade group 1 or 2, or PSA 10-20 ng/mL, and less than 50% of biopsy cores positive for carcinoma (i.e. for this trial, we will only include systematic biopsy cores, not targeted biopsy cores).
- ✓ 3. Age \>=18 years.
- ✓ 4. Eastern Cooperative Oncology Group (ECOG) performance status \<2 (Karnofsky \>60%).
- ✓ 5. Eligible to undergo High dose rate (HDR) brachytherapy as monotherapy as determined by the treating radiation oncologist.
- ✓ 6. Ability to understand and the willingness to sign a written informed consent document.
- ✓ 7. Human immunodeficiency virus (HIV)-infected individuals on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
- ✓ 8. For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
You may not qualify if…
- ✕ 1. Any prior treatment for prostate cancer.
- ✕ 2. Prior history of pelvic malignancy.
- ✕ 3. Any prior androgen deprivation therapy.
- ✕ 4. Is currently receiving any other investigational agents.
- ✕ 5. Abnormal pre-brachytherapy assessment raising concern for undergoing HDR brachytherapy procedure.
- ✕ 6. Contraindications to general anesthesia.
- ✕ 7. Contraindications to radiotherapy.
- ✕ 8. Prior history of pelvic radiotherapy.
Where it's recruiting
San Francisco
Source: ClinicalTrials.gov · NCT05665738 · last updated 2026-09-17