Taimur T Shah1, Max Peters2, David Eldred-Evans3, Saiful Miah4, Tet Yap5, Nicholas A Faure-Walker5, Feargus Hosking-Jervis3, Benjamin Thomas6, Tim Dudderidge7, Richard G Hindley8, Stuart McCracken9, Damian Greene10, Raj Nigam11, Massimo Valerio12, Suks Minhas13, Mathias Winkler14, Manit Arya15, Hashim U Ahmed14. 1. Division of Surgery, Department of Surgery and Cancer, Faculty of Medicine, Imperial College London, London, UK; Department of Urology, Charing Cross Hospital, Imperial College Healthcare NHS Trust, London, UK; Division of Surgery and Interventional Sciences, University College London, London, UK. Electronic address: t.shah@imperial.ac.uk. 2. Department of Radiotherapy, University Medical Centre, Utrecht, The Netherlands. 3. Division of Surgery, Department of Surgery and Cancer, Faculty of Medicine, Imperial College London, London, UK. 4. Division of Surgery, Department of Surgery and Cancer, Faculty of Medicine, Imperial College London, London, UK; Department of Urology, Charing Cross Hospital, Imperial College Healthcare NHS Trust, London, UK; Division of Surgery and Interventional Sciences, University College London, London, UK. 5. Department of Urology, Guy's Hospital, Great Maze Pond, London, UK. 6. Division of Surgery and Interventional Sciences, University College London, London, UK. 7. Department of Urology, University Hospital Southampton NHS Trust, Southampton, UK. 8. Department of Urology, Basingstoke and North Hampshire Hospital, Hampshire Hospitals NHS Foundation Trust, Basingstoke, UK. 9. Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, UK. 10. Department of Urology, Sunderland Royal Hospital, Sunderland, UK. 11. Department of Urology, Royal Surrey County Hospital NHS Trust, UK. 12. Department of Urology, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland. 13. Department of Urology, Charing Cross Hospital, Imperial College Healthcare NHS Trust, London, UK. 14. Division of Surgery, Department of Surgery and Cancer, Faculty of Medicine, Imperial College London, London, UK; Department of Urology, Charing Cross Hospital, Imperial College Healthcare NHS Trust, London, UK. 15. Division of Surgery, Department of Surgery and Cancer, Faculty of Medicine, Imperial College London, London, UK; Department of Urology, Charing Cross Hospital, Imperial College Healthcare NHS Trust, London, UK; Division of Surgery and Interventional Sciences, University College London, London, UK; Department of Urology, The Princess Alexandra Hospital NHS Trust, Harlow, UK.
Abstract
BACKGROUND: Focal cryotherapy can be used to treat patients with clinically significant nonmetastatic prostate cancer to reduce side effects. OBJECTIVE: Early-medium-term cancer control and functional outcomes. DESIGN, SETTING, AND PARTICIPANTS: A prospective registry-based case series of 122 consecutive patients undergoing focal cryotherapy between October 1, 2013, and November 30, 2016, in five UK centres. Median follow-up was 27.8mo [interquartile range (IQR) 19.5-36.7]. A total of 35 patients (28.7%) had National Comprehensive Cancer Network (NCCN) high risk and 87 (71.3%) had intermediate risk disease. Risk and zonal stratification included multiparametric magnetic resonance imaging (mpMRI) with targeted and systematic biopsies, or transperineal mapping biopsies. INTERVENTION: Focal cryoablation of MR-visible tumours. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Follow-up involved prostate-specific antigen (PSA) monitoring, mpMRI, and for-cause biopsies. Primary outcome was failure-free survival (FFS), defined as transition to radical, whole-gland, or systemic therapy, or metastases/death. Secondary outcomes included adverse events and functional outcomes. RESULTS AND LIMITATIONS: A total of 80 (65.6%) had anterior ablation, 23 (19.7%) combined posterior and anterior ablation, and two (1.6%) posterior ablation alone (SeedNet or Visual-ICE, BTG plc). Median age was 68.7yr (IQR 64.9-73.8) and preoperative PSA 10.8ng/ml (IQR 7.8-15.6). Overall FFS at 3yr was 90.5% [95% confidence interval (CI) 84.2-97.3]. When stratified for the NCCN risk group, 3-yr outcomes were 84.7% (95% CI 71.4-100) in high risk and 93.3% (95% CI 86.8-100) in intermediate risk. At last follow-up, incontinence defined as any pad use was 0/69 (0%) and erectile dysfunction (defined as erections insufficient for penetration) was 5/31 (16.1%). Limitations include lack of long-term outcomes. CONCLUSIONS: Focal cryotherapy primarily for anterior intermediate and high-risk prostate cancer results in good rates of cancer control and low rates of treatment-related side effects. PATIENT SUMMARY: In this multicentre study of 122 patients undergoing focal cryotherapy for medium- to high-risk prostate cancer, at 3yr, no patient died from their cancer whilst failure-free survival, was approximately 90%. None of the patients needed pads for managing urine leakage, although 16% had erection problems.
BACKGROUND: Focal cryotherapy can be used to treat patients with clinically significant nonmetastatic prostate cancer to reduce side effects. OBJECTIVE: Early-medium-term cancer control and functional outcomes. DESIGN, SETTING, AND PARTICIPANTS: A prospective registry-based case series of 122 consecutive patients undergoing focal cryotherapy between October 1, 2013, and November 30, 2016, in five UK centres. Median follow-up was 27.8mo [interquartile range (IQR) 19.5-36.7]. A total of 35 patients (28.7%) had National Comprehensive Cancer Network (NCCN) high risk and 87 (71.3%) had intermediate risk disease. Risk and zonal stratification included multiparametric magnetic resonance imaging (mpMRI) with targeted and systematic biopsies, or transperineal mapping biopsies. INTERVENTION: Focal cryoablation of MR-visible tumours. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Follow-up involved prostate-specific antigen (PSA) monitoring, mpMRI, and for-cause biopsies. Primary outcome was failure-free survival (FFS), defined as transition to radical, whole-gland, or systemic therapy, or metastases/death. Secondary outcomes included adverse events and functional outcomes. RESULTS AND LIMITATIONS: A total of 80 (65.6%) had anterior ablation, 23 (19.7%) combined posterior and anterior ablation, and two (1.6%) posterior ablation alone (SeedNet or Visual-ICE, BTGplc). Median age was 68.7yr (IQR 64.9-73.8) and preoperative PSA 10.8ng/ml (IQR 7.8-15.6). Overall FFS at 3yr was 90.5% [95% confidence interval (CI) 84.2-97.3]. When stratified for the NCCN risk group, 3-yr outcomes were 84.7% (95% CI 71.4-100) in high risk and 93.3% (95% CI 86.8-100) in intermediate risk. At last follow-up, incontinence defined as any pad use was 0/69 (0%) and erectile dysfunction (defined as erections insufficient for penetration) was 5/31 (16.1%). Limitations include lack of long-term outcomes. CONCLUSIONS: Focal cryotherapy primarily for anterior intermediate and high-risk prostate cancer results in good rates of cancer control and low rates of treatment-related side effects. PATIENT SUMMARY: In this multicentre study of 122 patients undergoing focal cryotherapy for medium- to high-risk prostate cancer, at 3yr, no patientdied from their cancer whilst failure-free survival, was approximately 90%. None of the patients needed pads for managing urine leakage, although 16% had erection problems.
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