Background: Salvage therapeutic options for biochemical failure after primary radiation-based therapy include radical prostatectomy, cryoablation, high-intensity focused ultrasound (HIFU), brachytherapy (for post-EBRT patients) and androgen deprivation therapy (ADT).
ADT and salvage prostate cryoablation (SPC) are two commonly considered treatment options for RRPC. However, there is an urgent need for high-quality clinical studies to support evidence-based decisions on treatment choice. Our study aims to determine the feasibility of randomising men with RRPC for treatment with ADT and SPC.
Methods: The randomised controlled trial (CROP) was developed, which incorporated protocols to assess parameters relating to cryotherapy procedures and provide training workshops for optimising patient recruitment. Analysis of data from the recruitment phase and patient questionnaires was performed.
Results: Over a period of 18 months, 39 patients were screened for eligibility. Overall 28 patients were offered entry into the trial, but only 7 agreed to randomisation. The majority reason for declining entry into the trial was an unwillingness to be randomised into the study. 'Having the chance of getting cryotherapy' was the major reason for accepting the trial. Despite difficulty in retrieving cryotherapy temperature parameters from prior cases, 9 of 11 cryotherapy centres progressed through the Cryotherapists Qualification Process (CQP) and were approved for recruiting into the CROP study.
Conclusions: Conveying equipoise between the two study arms for a salvage therapy was challenging. The use of delayed androgen therapy may have been seen as an inferior option. Future cohort studies into available salvage options (including prostate cryotherapy) for RRPC may be more acceptable to patients than randomisation within an RCT.
Written by:
Salji M, Jones R, Paul J, Birrell F, Dixon-Hughes J, Hutchison C, Johansen TE, Greene D, Parr N, Leung HY. Are you the author?
Department of Urology, NHS Greater Glasgow and Clyde, Glasgow, UK; Institute of Cancer Sciences, University of Glasgow, Glasgow, UK; Cancer Research UK Glasgow Centre, NHS Greater Glasgow and Clyde, Glasgow, UK; CRUK Clinical Trials Unit, University of Glasgow, Glasgow, UK; CRUK Clinical Trials Unit, University of Glasgow, Glasgow, UK; Department of Urology, NHS Greater Glasgow and Clyde, Glasgow, UK; Department of Urology, Oslo University Hospital, Oslo, Norway; Sunderland Royal Hospital, City Hospitals Sunderland, Sunderland, UK; Wirral University Teaching Hospital NHS Foundation Trust, Wirral, UK; Department of Urology, NHS Greater Glasgow and Clyde, Glasgow, UK; Institute of Cancer Sciences, University of Glasgow, Glasgow, UK; Sunderland Royal Hospital, City Hospitals Sunderland, Sunderland, UK; Beatson Institute, Glasgow, UK.
Reference: Br J Cancer. 2014 Jun 19. Epub ahead of print.
doi: 10.1038/bjc.2014.316
PubMed Abstract
PMID: 24946001
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