title: Achieving the 'bifecta' using salvage cryotherapy for locally recurrent prostate cancer: analysis of the Cryo On-Line Data (COLD) registry data.
abstract: Study Type - Outcomes (cohort). Level of Evidence 2b. What's known on the subject? and What does the study add? The cancer-specific outcomes of salvage cryotherapy for locally recurrent prostate cancer have been well established within contemporary scientific literature. However, very little is known about the outcomes of salvage cryotherapy encompassing health-related quality of life considerations such as continence after treatment. We think the present study is quite novel, as it proposes a new therapeutic endpoint to evaluate the efficacy and outcomes of salvage therapies for locally recurrent prostate cancer, which we have termed the 'bifecta'. In addition, we report that in a large multicentre data registry, such as the COLD Registry, the therapeutic 'bifecta' can be achieved in most patients.
  
  
  OBJECTIVE
  • To evaluate the contemporary outcomes of salvage cryotherapy for locally recurrent prostate cancer using the Cryo On-Line Data (COLD) Registry. • We also evaluate the outcomes of salvage cryotherapy in achieving the therapeutic 'bifecta' consisting of: (i) achieving a post-cryotherapy nadir serum PSA level of <0.6 ng/mL and (ii) no urinary incontinence.
  
  
  METHODS
  • A prospectively, centrally collected secure online database has been developed of patients undergoing salvage cryoablation for locally recurrent prostate cancer. Of the patients undergoing salvage cryotherapy (in the absence of neoadjuvant hormonal ablative therapy) included within the COLD Registry, complete medical records pertaining to continence status and serial PSA measurements after treatment were available in 183 patients.
  
  
  RESULTS
  • The therapeutic 'bifecta' was achieved in 133 of these patients (72.7%). • Of the patients achieving the 'bifecta', the mean (sd) age at presentation was 71.5 (6.6) years. • Most patients (91%) had a baseline pre-salvage total serum PSA level of <10 ng/mL and a pre-treatment biopsy Gleason score of <8 (85%). • The mean duration of follow-up of patients achieving the 'bifecta' was 36.5 months.
  
  
  CONCLUSIONS
  • The therapeutic 'bifecta', a new surrogate benchmark for salvage therapies, can be achieved in most patients undergoing salvage cryotherapy. • Therefore, salvage cryotherapy is a reasonable treatment choice for locally recurrent prostate cancer in appropriately selected patients.
authors: Department of Genitourinary Oncology, H. Lee Moffitt Cancer Center, Tampa, FL 33612, USA. philippe.spiess@moffi tt.org
authors: Philippe E
authors: PE
authors: Spiess
authors: Robert W
authors: RW
authors: Given
authors: J Stephen
authors: JS
authors: Jones
mesh_terms: D000368:Aged; D017679:Cryotherapy / Q000379:methods*; D006801:Humans; D008297:Male; D060787:Neoplasm Grading; D009364:Neoplasm Recurrence, Local / Q000097:blood / Q000628:therapy*; D011446:Prospective Studies; D017430:Prostate-Specific Antigen / Q000378:metabolism; D011471:Prostatic Neoplasms / Q000097:blood / Q000473:pathology / Q000628:therapy*; D012042:Registries; D016879:Salvage Therapy / Q000379:methods*; D016896:Treatment Outcome
chemical_list: D017430:Prostate-Specific Antigen