Abstract
BackgroundPelvic 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 & designPatients 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.DiscussionThis 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 registrationClinicalTrials.gov Identifier: NCT03569241, registered June 14, 2018, ;Identifier on Swiss National Clinical Trials Portal (SNCTP): SNCTP000002947, registered June 14, 2018.
Highlights
Pelvic nodal recurrences are being increasingly diagnosed with the introduction of new molecular imaging techniques, like choline and PSMA PET-Computed tomography (CT), in the restaging of recurrent prostate cancer (PCa)
Bruycker et al BMC Cancer (2020) 20:406 (Continued from previous page). This is the first prospective multicentre randomized phase II trial assessing the potential of combined whole pelvic radiotherapy (WPRT) and metastasis-directed therapies (MDT) as compared to MDT alone on metastasis-free survival (MFS) for patients with nodal oligorecurrent PCa
The entity regional nodal oligorecurrent PCa is not mentioned in the treatment guidelines but is an emerging clinical situation since the introduction of new molecular imaging techniques, such as choline and more recently PSMA PET-CT, in the restaging of recurrent PCa [2,3,4]
Summary
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. MDT, whether or not in combination with temporary androgen deprivation therapy (ADT), has the potential to reduce the subsequent risk of progression or even to cure limited regional nodal recurrence [5], and hereby postponing or even preempting the need for lifelong palliative ADT and its associated toxicity [9]
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