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

Phase 3

Completed

• Conditions: Prostate Cancer

• Registration Number: NCT00489060
• Lead Sponsor: University of Calgary

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.

Study Timeline

• Study Start: 1997-12
• Study Completion: 2007-04
• Study First Submitted: 2007-06-20
• Study First Submitted QC: 2007-06-20
• Study First Posted: 2007-06-21
• Status Verified: 2008-07
• Last Update Submitted: 2008-07-16
• Last Update Posted: 2008-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 244

Inclusion Criteria

• Clinically localized prostate cancer
• PSA < 20ng/ml
• Negative bone scan

Exclusion Criteria

• Previous TURP
• Previous hormone therapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
No evidence of disease progression (NEDP) at 36 months	36 months

Secondary Outcome Measures

Name	Time	Method
Prostate biopsy status	36 months post treatment

Trial Locations

Locations (1)

Tom Baker Cancer Center; 🇨🇦 Calgary, Alberta, Canada