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Brief Title: Two-fraction HDR Monotherapy for Localized Prostate Cancer
Official Title: Two-fraction High Dose Rate Brachytherapy as Monotherapy Delivered Three Hours Apart in Localized Prostate Cancer: A Pilot Study
Study ID: NCT05665738
Brief Summary: 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.
Detailed Description: 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. OUTLINE: Treatment will be administered on an outpatient basis. All treatment will be delivered over a single day. Participants will be followed for 6 months after last treatment or removal from study, or until death, whichever occurs first. Additional Follow up will be as per usual guidelines for prostate cancer, every 3 months following treatment with PSA for the first year, then every 4 months after year 2, and every 6 months after year 3 until 5 years of follow up are completed.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
University of California, San Francisco, San Francisco, California, United States
Name: I-Chow Hsu, MD
Affiliation: University of California, San Francisco
Role: PRINCIPAL_INVESTIGATOR