Peter Albers1, Thomas Wiegel2, Heinz Schmidberger3, Roswitha Bussar-Maatz4, Martin Härter5, Glen Kristiansen6, Peter Martus7, Christoph Meisner7, Stefan Wellek8, Klaus Grozinger9, Peter Renner10, Martin Burmester11, Fried Schneider12, Michael Stöckle13. 1. Department of Urology, University Hospital Düsseldorf, Düsseldorf, Germany. peter.albers@med.uni-duesseldorf.de. 2. Department of Radiotherapy and Radiation Oncology, University Hospital Ulm, Ulm, Germany. 3. Department of Radiotherapy and Radiation Oncology, University Hospital Mainz, Mainz, Germany. 4. PREFERE Project Management, German Cancer Society, Berlin, Germany. 5. Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany. 6. Institute of Pathology, University Hospital Bonn, Bonn, Germany. 7. Department of Biometry, University Hospital Tübingen, Tübingen, Germany. 8. Institute of Medical Biostatistics, Epidemiology and Informatics, University Medical Center, Johannes Gutenberg University Mainz, Mainz, Germany. 9. Department of Urology, Klinikum Leverkusen, Leverkusen, Germany. 10. Department of Urology, Urologisches Zentrum, Lübeck, Germany. 11. Department of Urology, Vincenz Krankenhaus, Hannover, Germany. 12. Department of Urology, Klinikum Lippe, Detmold, Germany. 13. Department of Urology, University Hospital Homburg/Saar, Homburg, Germany.
Abstract
PURPOSE: Active surveillance (AS) strategies for patients with low- and early intermediate-risk prostate cancer are still not consistently defined. Within a controlled randomized trial, active surveillance was compared to other treatment options for patients with prostate cancer. Aim of this analysis was to report on termination rates of patients treated with AS including different grade groups. METHODS: A randomized trial comparing radical prostatectomy, active surveillance, external beam radiotherapy and brachytherapy was performed from 2013 to 2016 and included 345 patients with low- and early intermediate-risk prostate cancer (ISUP grade groups 1 and 2). The trial was prematurely stopped due to slow accrual. A total of 130 patients were treated with active surveillance. Among them, 42 patients were diagnosed with intermediate-risk PCA. Reference pathology and AS quality control were performed throughout. RESULTS: After a median follow-up time of 18.8 months, 73 out of the 130 patients (56%) terminated active surveillance. Of these, 56 (77%) patients were histologically reclassified at the time of rebiopsy, including 35% and 60% of the grade group 1 and 2 patients, respectively. No patients who underwent radical prostatectomy at the time of reclassification had radical prostatectomy specimens ≥ grade group 3. CONCLUSION: In this prospectively analyzed subcohort of patients with AS and conventional staging within a randomized trial, the 2-year histological reclassification rates were higher than those previously reported. Active surveillance may not be based on conventional staging alone, and patients with grade group 2 cancers may be recommended for active surveillance in carefully controlled trials only.
RCT Entities:
PURPOSE: Active surveillance (AS) strategies for patients with low- and early intermediate-risk prostate cancer are still not consistently defined. Within a controlled randomized trial, active surveillance was compared to other treatment options for patients with prostate cancer. Aim of this analysis was to report on termination rates of patients treated with AS including different grade groups. METHODS: A randomized trial comparing radical prostatectomy, active surveillance, external beam radiotherapy and brachytherapy was performed from 2013 to 2016 and included 345 patients with low- and early intermediate-risk prostate cancer (ISUP grade groups 1 and 2). The trial was prematurely stopped due to slow accrual. A total of 130 patients were treated with active surveillance. Among them, 42 patients were diagnosed with intermediate-risk PCA. Reference pathology and AS quality control were performed throughout. RESULTS: After a median follow-up time of 18.8 months, 73 out of the 130 patients (56%) terminated active surveillance. Of these, 56 (77%) patients were histologically reclassified at the time of rebiopsy, including 35% and 60% of the grade group 1 and 2 patients, respectively. No patients who underwent radical prostatectomy at the time of reclassification had radical prostatectomy specimens ≥ grade group 3. CONCLUSION: In this prospectively analyzed subcohort of patients with AS and conventional staging within a randomized trial, the 2-year histological reclassification rates were higher than those previously reported. Active surveillance may not be based on conventional staging alone, and patients with grade group 2 cancers may be recommended for active surveillance in carefully controlled trials only.
Entities:
Keywords:
Active surveillance; Clinical trial; Prostate cancer; Reclassification
Authors: David E Neal; Chris Metcalfe; Jenny L Donovan; J Athene Lane; Michael Davis; Grace J Young; Susan J Dutton; Eleanor I Walsh; Richard M Martin; Tim J Peters; Emma L Turner; Malcolm Mason; Richard Bryant; Prasad Bollina; James Catto; Alan Doherty; David Gillatt; Vincent Gnanapragasam; Peter Holding; Owen Hughes; Roger Kockelbergh; Howard Kynaston; Jon Oxley; Alan Paul; Edgar Paez; Derek J Rosario; Edward Rowe; John Staffurth; Doug G Altman; Freddie C Hamdy Journal: Eur Urol Date: 2019-11-24 Impact factor: 20.096
Authors: Thomas Wiegel; Peter Albers; Detlef Bartkowiak; Roswitha Bussar-Maatz; Martin Härter; Glen Kristiansen; Peter Martus; Stefan Wellek; Heinz Schmidberger; Klaus Grozinger; Peter Renner; Fried Schneider; Martin Burmester; Michael Stöckle Journal: J Cancer Res Clin Oncol Date: 2021-04 Impact factor: 4.553