ESTRO 2022

Session Item

Sunday

May 08

16:55 - 17:55

Room D3

Oligometastatic disease

Co-Chair: , Austria;

Chair: Jonas Willmann, Switzerland

Session Type: Proffered Papers

Track: Clinical

Journey:

17:35 - 17:45

PEACE V – STORM randomized phase II trial for oligorecurrent nodal prostate cancer: acute toxicity

, Switzerland

Presentation Number: OC-0603

Abstract

Abstract Title:

PEACE V – STORM randomized phase II trial for oligorecurrent nodal prostate cancer: acute toxicity

Authors:

Thomas Zilli¹, Shankar Siva², Reino Heikkilä³, Piet Dirix⁴, Nick Liefhooghe⁵, François-Xavier Otte⁶, Alfonso Gomez-Iturriaga⁷, Wouter Everaerts⁸, Mohamed Shelan⁹, Antonio Conde-Moreno¹⁰, Fernando López Campos¹¹, Alexandros Papachristofilou¹², Matthias Guckenberger¹³, Marta Scorsetti¹⁴, Almudena Zapatero¹⁵, Ana-Elena Villafranca Iturre¹⁶, Clara Eito¹⁷, Felipe Couñago¹⁸, Paolo Muto¹⁹, Lien Van De Voorde²⁰, Valérie Fonteyne²¹, Daniel Moon²², Kristian Thon³, Carole Mercier⁴, Vérane Achard¹, Karin Stellamans²³, Els Goetghebeur²⁴, Dries Reynders²⁴, Piet Ost²⁵

¹Geneva University Hospital, University of Geneva, Radiation Oncology, Geneva, Switzerland; ²Epworth Healthcare and Sir Peter MacCallum, University of Melbourne, Department of Oncology, Melbourne, Australia; ³Oslo University Hospital, Radiation Oncology, Oslo, Norway; ⁴Iridium netwerk, GZA Ziekenhuizen, Radiation Oncology, Antwerp, Belgium; ⁵AZ Groeninge, Kortrijk, Radiation Oncology, Kortrijk, Belgium; ⁶Jules Bordet Institute, Radiation Oncology, Brussels, Belgium; ⁷Hospital Universitario Cruces, Radiation oncology, Barakaldo, Spain; ⁸University Hospitals Leuven, Urology, Leuven, Belgium; ⁹Inselspital, Bern University Hospital, University of Bern, Radiation Oncology, Bern, Switzerland; ¹⁰Hospital Universitari i Politècnic la Fe, Radiation Oncology, Valencia, Spain; ¹¹Hospital Universitario Ramón y Cajal, Radiation Oncology, Madrid, Spain; ¹²University Hospital Basel, Radiation Oncology, Basel, Switzerland; ¹³University Hospital Zurich, University of Zurich, Radiation Oncology, Zürich, Switzerland; ¹⁴Humanitas University, Pieve Emanuele (Milan) -IRCCS Humanitas Research Hospital, Radiotherapy and Radiosurgery Department, Rozzano, Italy; ¹⁵University Hospital La Princesa, Radiation Oncology, Madrid, Spain; ¹⁶Complejo Hospitalario de Navarra, Radiation Oncology, Navarra, Spain; ¹⁷Instituto Oncólogico Clinica Universitaria IMQ, Radiation Oncology, Bilbao, Spain; ¹⁸University Hospital Quironsalud, Universidad Europea de Madrid, Radiation Oncology, Madrid, Spain; ¹⁹Napoli Istituto Nazionale Tumori IRCCS Fondazione Pascale, Radiation Oncology, Napoli, Italy; ²⁰AZ St-Lucas Ghent, Radiation Oncology, Ghent, Belgium; ²¹Department of Human Structure and Repair, Ghent University, Radiation Oncology, Ghent, Belgium; ²²University of Melbourne, (Royal Melbourne clinical school), Urology, Melbourne, Australia; ²³AZ Groeninge, Radiation Oncology, Kortrijk, Belgium; ²⁴Ghent University, Department of Applied Mathematics, Computer Science and Statistics, Ghent, Belgium; ²⁵Department of Human structure and repair, Ghent University, Radiation Oncology, Ghent, Belgium

Show Affiliations

Purpose or Objective

Pelvic nodal recurrences are being increasingly diagnosed in prostate cancer (PCa) patients with the introduction of new molecular imaging techniques, like choline and PSMA PET-CT. At this moment, there are no specific treatment recommendations for patients with limited nodal recurrences and different locoregional treatment approaches are currently being used. The aim of this prospective multicentre randomized controlled phase II trial is to compare metastasis directed therapy (MDT) with elective nodal pelvic radiotherapy (ENRT).

Material and Methods

STORM is an international, phase II, open-label, randomised, superiority trial. Patients diagnosed with PET-detected pelvic nodal oligorecurrence (≤5 nodes) following radical local treatment for PCa, were randomized in a 1:1 ratio between arm A: MDT and 6 months of androgen deprivation therapy (ADT), or arm B: ENRT (25x1.8Gy) with MDT and 6 months of ADT. Patients were stratified by type of PET-tracer (choline or PSMA) and by type of MDT (surgery or radiotherapy). In case of radiotherapy, SBRT (3x10Gy) was used for arm A, with a simultaneous integrated boost (25x2.6Gy) in arm B. The primary endpoint is metastasis-free survival and here we report the secondary endpoint acute toxicity, defined as worst grade 2 or more CTCAEv4.0 gastrointestinal (GI) or genitourinary (GU) toxicity, exceeding baseline, up to 3 months after radiotherapy. The chi-square test was used to compare toxicity between treatment arms. This study is registered on ClinicalTrials.gov Identifier: NCT03569241

Results

Between June, 2018 and April 2021, 196 patients were randomly assigned to MDT or ENRT. 96 of 98 allocated to MDT and 93 of 98 patients allocated to ENRT received at least one fraction of the allocated treatment. Initial treatment at diagnosis was radical prostatectomy in 166 patients (88%) with lymph node dissection in 96 patients (49%). At time of nodal recurrence, the median PSA was 0.97 ng/ml (interquartile range 0.45-2.3). The PET-tracer was choline in 32 (17%) patients and PSMA in 157 (83%) patients. Patients were diagnosed with a single node, 2 nodes or 3-5 nodes in 110 (58%), 49 (26%), 28 (15%) patients (missing information for 2 patients). Surgery was the MDT type of choice in only 11 patients (6%). GI and GU toxicity at baseline, month 1 and month 3 are displayed in figure 1. Worst acute GI toxicity proportions were as follows: grade 2 or higher events in 1 (1%) in the MDT group versus 3 (3%) in the ENRT group (p=0.13). Worst acute GU toxicity proportions were as follows: grade 2 or higher events in 8 (8%) in the MDT group versus 13 (13%) in the ENRT group (p=0.54). Two patients developed a grade 3 event (diarrhoea and urinary incontinence with pre-existing grade 2) in the ENRT arm.

Conclusion

Although ENRT treats a more extensive part of the pelvis as compared to MDT, ENRT does not seem to result in a clinically meaningful increase in acute GI or GU toxicity.