PEACE V - Salvage Treatment of OligoRecurrent nodal prostate cancer Metastases (STORM): a study protocol for a randomized controlled phase II trial.
- De Bruycker A Department of Radiation oncology and experimental cancer research, Ghent University Hospital, Ghent, Belgium.
- Spiessens A Department of Radiation oncology and experimental cancer research, Ghent University Hospital, Ghent, Belgium.
- Dirix P Department of Radiation oncology, Iridium Cancer Network, GZ Antwerp, Antwerp, Belgium.
- Koutsouvelis N Department of Radiation oncology, Geneva University Hospital, Geneva, Switzerland.
- Semac I Department of Radiation oncology, Geneva University Hospital, Geneva, Switzerland.
- Liefhooghe N Department of Radiation oncology, AZ Groeninge, Kortrijk, Belgium.
- Gomez-Iturriaga A Cruces University Hospital (Biocruces Health Research Institute), Barakaldo, Spain.
- Everaerts W Department of Development and Regeneration, KU Leuven, Leuven, Belgium.
- Otte F Department of Radiation oncology, Jules Bordet Institute and Hôpital Erasme, University Clinics of Brussels, Université Libre de Bruxelles, Brussels, Belgium.
- Papachristofilou A Clinic of Radiotherapy & Radiation Oncology, University Hospital Basel, Basel, Switzerland.
- Scorsetti M Humanitas Clinical and Research Hospital, IRCSS, Radiotherapy and Radiosurgery Department, Rozzano, Milan, Italy.
- Shelan M Department of Radiation oncology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.
- Siva S Epworth Healthcare, University of Melbourne, Melbourne, Australia.
- Ameye F Department of Urology, AZ Maria-Middelares Ghent, Ghent, Belgium.
- Guckenberger M Department of Radiation Oncology, University Hospital Zürich, University of Zurich, Zürich, Switzerland.
- Heikkilä R Department of Oncology, Oslo University Hospital, Oslo, Norway.
- Putora PM Department of Radiation oncology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.
- Zapatero A University Hospital La Princesa, Madrid, Spain.
- Conde-Moreno A Department of Radiation oncology, Hospital Universitari i Politècnic la Fe, Valencia, Spain.
- Couñago F Department of Radiation oncology, University Hospital of Quirón, Madrid, Spain.
- Vanhoutte F Department of Radiation oncology and experimental cancer research, Ghent University Hospital, Ghent, Belgium.
- Goetghebeur E Department of Applied Mathematics, Computer Science and Statistics, Ghent University, Ghent, Belgium.
- Reynders D Department of Applied Mathematics, Computer Science and Statistics, Ghent University, Ghent, Belgium.
- Zilli T Department of Radiation oncology, Geneva University Hospital, Geneva, Switzerland. Thomas.Zilli@hcuge.ch.
- Ost P Department of Radiation oncology and experimental cancer research, Ghent University Hospital, Ghent, Belgium. piet.ost@ugent.be.
- 2020-05-14
Published in:
- BMC cancer. - 2020
Androgen deprivation therapy
Metastasis-directed therapy
Oligometastases
Oligorecurrence
Prostate cancer
Quality of life
Salvage lymph node dissection
Stereotactic body radiotherapy
Survival
Whole pelvic radiotherapy
English
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.
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.
- Language
-
- English
- Open access status
- gold
- Identifiers
-
- DOI 10.1186/s12885-020-06911-4
- PMID 32398040
- Persistent URL
- https://folia.unifr.ch/global/documents/45319
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