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Randomized trial comparing cryoablation and external beam radiotherapy for T2C-T3B prostate cancer

Abstract

The objective was to evaluate the relative efficacy of cryoablation (CRYO) versus external beam radiation (EBRT) for clinically locally advanced prostate cancer in a randomized clinical trial. Patients with histologically proven, clinically staged as T2C, T3A or T3B disease were randomized with 6 months of perioperative hormone therapy to one of the two procedures. Owing largely to a shift in practice to longer term adjuvant hormonal therapy and higher doses of radiation for T3 disease, only 64 out of the planned 150 patients were accrued. Twenty-one of 33 (64%) in the CRYO group and 14 of 31 (45%) in the EBRT-treated group who had met the ASTRO definition of failure were also classified as treatment failure. The mean biochemical disease-free survival (bDFS) was 41 months for the EBRT group compared to 28 months for the CRYO group. The 4-year bDFS for EBRT and CRYO groups were 47 and 13%, respectively. Disease-specific survival (DSS) and overall survival (OS) for both groups were very similar. Serious complications were uncommon in either group. EBRT patients exhibited gastrointestinal (GI) adverse effects more frequently. Taking into account the relative deficiency in numbers and the original trial design, this prospective randomized trial indicated that the results of CRYO were less favorable compared to those of EBRT, and was suboptimal primary therapy in locally advanced prostate cancer.

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Acknowledgements

This work is supported by a research Grant from AstraZeneca, Canada.

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Correspondence to J L Chin.

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The subject matter of this manuscript has been presented, in part or in whole, at (1) Canadian Urological Association Annual Meeting, June 2005; (2) Northeastern Section of American Urological Association Annual Meeting, November 2005; (3) American Urological Association Meeting, May 2006; (4) Canadian Association of Radiation Oncology Annual Meeting 2005.

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Chin, J., Ng, CK., Touma, N. et al. Randomized trial comparing cryoablation and external beam radiotherapy for T2C-T3B prostate cancer. Prostate Cancer Prostatic Dis 11, 40–45 (2008). https://doi.org/10.1038/sj.pcan.4500988

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