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.
Two-fraction High Dose Rate Brachytherapy as Monotherapy Delivered Three Hours Apart in Localized Prostate Cancer: A Pilot Study
PRIMARY OBJECTIVES: I. To determine the safety of HDR monotherapy 13.5 Gy x 2 fractions delivered 3 hours apart in patients with low and intermediate risk prostate cancer. SECONDARY OBJECTIVES: I. To describe the prostate specific antigen (PSA) kinetics associated with HDR brachytherapy monotherapy 13.5 Gy x 2 fractions delivered 3 hours apart for low and intermediate risk prostate cancer. II. To describe international prostate symptom score (IPSS) changes from baseline after treatment. OUTLINE: Treatment will be administered on an outpatient basis. All treatment will be delivered over a single day. Participants will be followed for 2 years after last treatment or removal from study, or until death, whichever occurs first.