A Phase 2 Study of Bicalutamide Plus Finasteride in Men with MRI Detectable Prostate Nodules Undergoing Active Surveillance
Determine if a 3-month course of combination bicalutamide plus finasteride will lead to a negative re-biopsy of MRI-detectable significant prostate nodules in active surveillance patients at Johns Hopkins with low-risk prostate cancer, as determined by an MRI/transrectal ultrasound (TRUS) fusion guided biopsy.
Men equal to / greater than 18 years of age with very low-risk prostate cancer (i.e., T1c stage, PSA density less than 0.15 ng/mL, PSA less than 10 ng/mL, Gleason equal to 6, equal to 2 cores involved and equal to 50% cancer in any given core) enrolled on active surveillance and with an MRI detectable significant prostate nodule. Not allowed: prior local therapy to treat prostate cancer (e.g., radical prostatectomy, radiation therapy, brachytherapy); prior use of bicalutamide or finasteride within the past year; hormonal therapy, et al treatments; abnormal liver, kidney, or cardiac function.
Study Design: This is an open label, single site, single arm Phase II study to evaluate the combination of bicalutamide plus finasteride in men with MRI detectable significant prostate nodules followed on active surveillance. Treatment Plan: Eligible patients will receive a 3-month (90-day) course of bicalutamide 50 mg by mouth daily and finasteride 5 mg by mouth daily. These doses were selected given that they are the current Food and Drug Administration approved single-agent doses.
11/26/2014 04:10 AM