Salvage ablative therapy in prostate cancer: International multidisciplinary consensus on trial design.

INTRODUCTION - Salvage ablative therapy (SAT) has been developed as a form of localized treatment for localized recurrence of prostate cancers following radiation therapy. To better address the utility of SAT, prospective clinical trials must address the aspects of accepted standards in the initial evaluation, treatment, follow-up, and outcomes in the oncology community. We undertook this study to achieve consensus on uniform standardized trial design for SAT trials.

METHODS - A literature search was performed and an international multidisciplinary group of experts was identified. A questionnaire was constructed and sent out to 71 participants in 3 consecutive rounds according to the Delphi method. The project was concluded with a face-to-face meeting in which the results were reviewed and conclusions were formulated.

RESULTS - Patients with recurrent disease after radiation therapy were considered candidates for a SAT trial using any ablation scenario performed with cryotherapy or high-intensity focused ultrasound. It is feasible to compare different sources of energy or to compare with historical data on salvage radical prostatectomy outcomes. The primary objective should be to assess the efficacy of the treatment for negative biopsy rate at 12 months. Secondary objectives should include safety parameters and quality-of-life assessment. Exclusion criteria should include evidence of local or distant metastases. The optimal biopsy strategy is image-guided targeted biopsies. Follow-up includes multiparametric magnetic resonance imaging, prostate-specific antigen level, and quality of life for at least 5 years.

CONCLUSIONS - A multidisciplinary board from international experts reached consensus on trial design for SAT in prostate cancer and provides a standard for designing a feasible SAT trial.

Urol Oncol. 2015 Jul 28. pii: S1078-1439(15)00324-5. doi: 10.1016/j.urolonc.2015.06.015. [Epub ahead of print]

van den Bos W1, Muller BG2, de Bruin DM2, de Castro Abreu AL3, Chaussy C4, Coleman JA5, Finelli A6, Gill IS7, Gross ME7, Jenniskens SF8, Kahmann F9, Laguna-Pes MP2, Rastinehad AR10, Simmons LA11, Sulser T12, Villers A13, Ward JF14, de la Rosette JJ2.

1 Department of Urology, AMC University Hospital, Amsterdam, the Netherlands.
2 Department of Urology, AMC University Hospital, Amsterdam, the Netherlands.
3 Department of Urology, University of Southern California, Los Angeles, CA.
4 Department of Urology, University of Regensburg, Regensburg, Germany.
5 Department of Surgery, Memorial Sloan-Kettering Cancer Center, New York, NY.
6 Departmant of Surgical Oncology, Princess Margaret Hospital, Toronto, Ontario, Canada.
7 Department of Urology, Keck School of Medicine, Los Angeles, CA.
8 Department of Radiology, Radboud University Nijmegen Medical Center, Nijmegen, the Netherlands.
9 Praxis Henkel & Kahmann, Berlin, Germany.
10 Department of Urology, Hofstra North Shore-Lij, Hofstra University, Hempstead, NY.
11 Department of Urology, University College London, London, UK.
12 Department of Urology, University Hospital Zurich, Zurich, Switzerland.
13 Department of Urology, Lille University Medical Center, Lille, France.
14 Department of Urology, The University of Texas MD Anderson Cancer Center, Houston, TX.