title: Feasibility study of a randomised controlled trial to compare (deferred) androgen deprivation therapy and cryotherapy in men with localised radiation-recurrent prostate cancer.
abstract: 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.
authors.affiliation: 1] Department of Urology, NHS Greater Glasgow and Clyde, Glasgow, UK [2] Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.
authors.forename: M
authors.initials: M
authors.lastname: Salji
authors.affiliation: 1] Institute of Cancer Sciences, University of Glasgow, Glasgow, UK [2] Cancer Research UK Glasgow Centre, NHS Greater Glasgow and Clyde, Glasgow, UK [3] CRUK Clinical Trials Unit, University of Glasgow, Glasgow, UK.
authors.forename: R
authors.initials: R
authors.lastname: Jones
authors.affiliation: 1] Cancer Research UK Glasgow Centre, NHS Greater Glasgow and Clyde, Glasgow, UK [2] CRUK Clinical Trials Unit, University of Glasgow, Glasgow, UK.
authors.forename: J
authors.initials: J
authors.lastname: Paul
authors.affiliation: Department of Urology, NHS Greater Glasgow and Clyde, Glasgow, UK.
authors.forename: F
authors.initials: F
authors.lastname: Birrell
authors.affiliation: 1] Cancer Research UK Glasgow Centre, NHS Greater Glasgow and Clyde, Glasgow, UK [2] CRUK Clinical Trials Unit, University of Glasgow, Glasgow, UK.
authors.forename: J
authors.initials: J
authors.lastname: Dixon-Hughes
authors.affiliation: 1] Cancer Research UK Glasgow Centre, NHS Greater Glasgow and Clyde, Glasgow, UK [2] CRUK Clinical Trials Unit, University of Glasgow, Glasgow, UK.
authors.forename: C
authors.initials: C
authors.lastname: Hutchison
authors.affiliation: Department of Urology, Oslo University Hospital, Oslo, Norway.
authors.forename: T E B
authors.initials: TE
authors.lastname: Johansen
authors.affiliation: Sunderland Royal Hospital, City Hospitals Sunderland, Sunderland, UK.
authors.forename: D
authors.initials: D
authors.lastname: Greene
authors.affiliation: Wirral University Teaching Hospital NHS Foundation Trust, Wirral, UK.
authors.forename: N
authors.initials: N
authors.lastname: Parr
authors.affiliation: 1] Department of Urology, NHS Greater Glasgow and Clyde, Glasgow, UK [2] Institute of Cancer Sciences, University of Glasgow, Glasgow, UK [3] Sunderland Royal Hospital, City Hospitals Sunderland, Sunderland, UK [4] Beatson Institute, Glasgow, UK.
authors.forename: H Y
authors.initials: HY
authors.lastname: Leung
mesh_terms: D000726:Androgen Antagonists / Q000627:therapeutic use; D003452:Cryosurgery; D005240:Feasibility Studies; D006801:Humans; D008297:Male; D015337:Multicenter Studies as Topic; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy* / Q000601:surgery; D010342:Patient Acceptance of Health Care; D011471:Prostatic Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy / Q000601:surgery; D016032:Randomized Controlled Trials as Topic; D016879:Salvage Therapy
chemical_list: D000726:Androgen Antagonists