Spots Global Cancer Trial Database for A Randomized Trial of External Beam Radiotherapy Versus Cryoablation in Patients With Localized Prostate Cancer
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Trial Identification
Brief Title: A Randomized Trial of External Beam Radiotherapy Versus Cryoablation in Patients With Localized Prostate Cancer
Official Title: A Randomized Trial of External Beam Radiotherapy Versus Cryoablation in Patients With Clinically Localized Prostate Cancer
Study ID: NCT00489060
Conditions
Interventions
Study Description
Brief Summary: A trial to determine if cryoablation is as effective as radiation in the treatment of men with localized prostate cancer.
Detailed Description: 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.
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
Tom Baker Cancer Center, Calgary, Alberta, Canada
Contact Details
Name: Bryan Donnelly, MD
Affiliation: Tom Baker Cancer Center
Role: PRINCIPAL_INVESTIGATOR
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