Two-fraction HDR Monotherapy for Localized Prostate Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorUniversity of California, San Francisco
About this trial
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.
Eligibility criteria
Qualifiers
Participants must have histologically or cytologically confirmed diagnosis of prostate adenocarcinoma.
National Comprehensive Cancer Network low to intermediate risk stratification.
No prior treatment for prostate cancer and no prior androgen deprivation therapy.
Age >=18 years.
Disqualifiers
Any prior treatment for prostate cancer.
Any prior androgen deprivation therapy.
Is currently receiving any other investigational agents.
Abnormal pre-brachytherapy assessment raising concern for undergoing HDR brachytherapy procedure.
Trial design
Treatments tested in this trial
- High Dose Rate Monotherapy
Treatment groups
17 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov