Our aim was to evaluate the effect of addition of radical prostatectomy (RP) to best systemic therapy (BST) on cancer-specific mortality (CSM) in patients with oligometastatic prostate cancer (omPC).
This randomised controlled trial included patients with omPC with a low metastatic burden (1-5 bone metastases with/without nodal involvement) on conventional or PET imaging. Patients were randomised to receive either RP with pelvic lymph-node dissection plus BST (RP + BST) or BST alone. The primary endpoint was CSM. Secondary endpoints included clinical progression and overall survival (OS). Study accrual was stopped early because of a change in medical practice. Statistical analyses included cumulative incidence plots, Gray's test, competing-risks regression, Kaplan-Meier estimates, and log-rank tests.
Between May 2015 and December 2018, 132 patients were randomised. The median age was 67 yr (interquartile range 63-71) and median prostate-specific antigen was 20 ng/ml (interquartile range 10-39). The 5-yr CSM cumulative incidence was 13% for RP + BST and 23% for BST alone (p = 0.037), with a hazard ratio of 0.39 (95% confidence interval 0.16-0.98; p = 0.045). The 5-yr cumulative incidence of clinical progression including CSM was 59% for RP + BST and 60% for BST alone. The 5-yr OS rate was 81% for RP + BST and 74% for BST alone. Clavien-Dindo grade ≥III surgery-related complications occurred in nine of 66 (14%) patients in the RP + BST arm. Limitations include early discontinuation of study accrual and the lack of statistical significance for the OS benefit.
While this trial has substantial limitations, the results support addition of RP as local therapy to BST in omPC. This trial is registered on ClinicalTrials.gov as NCT02454543.
European urology. 2025 Oct 03 [Epub ahead of print]
Markus Graefen, Fabian Falkenbach, Tobias Maurer, Lars Budäus, Derya Tilki, Pierre I Karakiewicz, Markus Aly, Peter Wiklund, Klaus Brasso, Andreas Røder, Mads H Poulsen, Martin Schostak, Christiane Görtzen, Anke Renter, Gunhild von Amsberg, Alexander Haese, Hans Heinzer, Georg Salomon, Thomas Steuber, Burkhard Beyer
Martini-Klinik Prostate Cancer Center, University Medical Center Hamburg-Eppendorf, Hamburg, Germany., Martini-Klinik Prostate Cancer Center, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; Cancer Prognostics and Health Outcomes Unit, Division of Urology, University of Montréal Health Center, Montréal, Canada. Electronic address: ., Martini-Klinik Prostate Cancer Center, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; Department of Urology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany., Martini-Klinik Prostate Cancer Center, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; Department of Urology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; Department of Urology, Koc University Hospital, Istanbul, Turkey., Cancer Prognostics and Health Outcomes Unit, Division of Urology, University of Montréal Health Center, Montréal, Canada., Department of Pelvic Cancer, Karolinska University Hospital, Stockholm, Sweden., Copenhagen Prostate Cancer Center, Department of Urology, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark., Department of Urology, Esbjerg and Grindsted Hospital, University of Southern Denmark, Esbjerg, Denmark., Department of Urology, Uro-oncology, Robot-assisted and Focal Therapy, Magdeburg University Hospital, Magdeburg Otto-von-Guericke University, Magdeburg, Germany; LOGICURO, Berlin, Germany., Martini-Klinik Prostate Cancer Center, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; University Cancer Center Hamburg, University Hospital Hamburg-Eppendorf, Hamburg, Germany., Klinik Wildetal, Urologisches Kompetenzzentrum für die Rehabilitation, Bad Wildungen, Germany.