PEACE V – Salvage Treatment of OligoRecurrent nodal prostate cancer Metastases (STORM): a study protocol for a randomized controlled phase II trial

BMC Cancer - Tập 20 Số 1 - 2020
Aurélie De Bruycker1, An Spiessens1, Piet Dirix2, Nikolaos Koutsouvelis3, Isabelle Semac3, Nick Liefhooghe4, A. Gómez-Iturriaga5, Wouter Everaerts6, François-Xavier Otte7, Alexandros Papachristofilou8, Marta Scorsetti9, Mohamed Shelan10, Shankar Siva11, Filip Ameye12, Matthias Gückenberger13, Reino Heikkilä14, Paul Martin Putora10, A. Zapatero15, A. Conde16, Felipe Couñago17, F. Vanhoutte1, Els Goetghebeur18, Dries Reynders18, Thomas Zilli3, Piet Ost1
1Department of Radiation Oncology and Experimental Cancer Research, Ghent University Hospital, Ghent, Belgium
2Department of Radiation oncology, Iridium Cancer Network, GZ Antwerp, Antwerp, Belgium
3Department of Radiation Oncology, Geneva University Hospital, Geneva, Switzerland
4Department of Radiation Oncology, AZ Groeninge, Kortrijk, Belgium
5Cruces University Hospital, BioCruces Health Research Institute, Barakaldo, Spain
6Department of Development and Regeneration, KU Leuven, Leuven, Belgium
7Department of Radiation oncology, Jules Bordet Institute and Hôpital Erasme, University Clinics of Brussels, Université Libre de Bruxelles, Brussels, Belgium
8Clinic of Radiotherapy & Radiation Oncology, University Hospital Basel, Basel, Switzerland
9Humanitas Clinical and Research Hospital, IRCSS, Radiotherapy and Radiosurgery Department, Rozzano, Milan, Italy
10Department of Radiation Oncology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland
11Epworth Healthcare, University of Melbourne, Melbourne, Australia
12Department of Urology, AZ Maria-Middelares Ghent, Ghent, Belgium
13Department of Radiation Oncology, University Hospital Zürich, University of Zurich, Zürich, Switzerland
14Department of Oncology, Oslo University Hospital, Oslo, Norway
15University Hospital La Princesa, Madrid, Spain
16Department of Radiation Oncology, Hospital Universitari i Politècnic la Fe, Valencia, Spain
17Department of Radiation oncology, University Hospital of Quirón, Madrid, Spain
18Department of Applied Mathematics, Computer Science and Statistics, Ghent University, Ghent, Belgium

Tóm tắt

Abstract Background Pelvic nodal recurrences are being increasingly diagnosed with the introduction of new molecular imaging techniques, like choline and PSMA PET-CT, in the restaging of recurrent prostate cancer (PCa). At this moment, there are no specific treatment recommendations for patients with limited nodal recurrences and different locoregional treatment approaches are currently being used, mostly by means of metastasis-directed therapies (MDT): salvage lymph node dissection (sLND) or stereotactic body radiotherapy (SBRT). Since the majority of patients treated with MDT relapse within 2 years in adjacent lymph node regions, with an estimated median time to progression of 12–18 months, combining MDT with whole pelvic radiotherapy (WPRT) may improve oncological outcomes in these patients. The aim of this prospective multicentre randomized controlled phase II trial is to assess the impact of the addition of WPRT to MDT and short-term androgen deprivation therapy (ADT) on metastasis-free survival (MFS) in the setting of oligorecurrent pelvic nodal recurrence. Methods & design Patients diagnosed with PET-detected pelvic nodal oligorecurrence (≤5 nodes) following radical local treatment for PCa, will be randomized in a 1:1 ratio between arm A: MDT and 6 months of ADT, or arm B: WPRT added to MDT and 6 months of ADT. Patients will be stratified by type of PET-tracer (choline, FACBC or PSMA) and by type of MDT (sLND or SBRT). The primary endpoint is MFS and the secondary endpoints include clinical and biochemical progression-free survival (PFS), prostate cancer specific survival, quality of life (QoL), toxicity and time to castration-resistant prostate cancer (CRPC) and to palliative ADT. Estimated study completion: December 31, 2023. Discussion This is the first prospective multicentre randomized phase II trial assessing the potential of combined WPRT and MDT as compared to MDT alone on MFS for patients with nodal oligorecurrent PCa. Trial registration ClinicalTrials.gov Identifier: NCT03569241, registered June 14, 2018, ; Identifier on Swiss National Clinical Trials Portal (SNCTP): SNCTP000002947, registered June 14, 2018.

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