Trial Information

A Randomized Trial of External Beam Radiotherapy Versus Cryoablation in Patients With Clinically Localized Prostate Cancer

Men with newly diagnosed localized prostate cancer were randomly assigned to cryoablation or
external beam radiotherapy (median dose 68 Gy). All patients received neoadjuvant
antiandrogen therapy. The primary endpoint was disease progression at 36 months based on a
trifecta definition of failure: (a) radiological evidence of metastatic disease or b)
initiation of further antineoplastic therapy or c) biochemical failure). Two definitions of
biochemical failure were used: 1) rising PSA with a final value >1.0 ng/mL and 2) rise above
PSA nadir + 2 ng/mL. Secondary endpoints were overall survival, disease-specific survival,
and positive prostate biopsy at 36 months.