PEARLS: A multicenter phase II/III trial of extended field radiotherapy for androgen-sensitive prostate cancer patients with PSMA‐avid pelvic and para-aortic lymph nodes at presentation.

Medientyp: E-Artikel

Titel: PEARLS: A multicenter phase II/III trial of extended field radiotherapy for androgen-sensitive prostate cancer patients with PSMA‐avid pelvic and para-aortic lymph nodes at presentation

Beteiligte: Murray, Julia; Cruickshank, Clare; Bird, Thomas; Bell, Philip; Braun, John; Chuter, Dave; Davda, Reena; Ferreira, Miguel Reis; Griffin, Clare; Hujairi, Nabil; Melcher, Alan; Miles, Elizabeth; Naismith, Olivia; Rekowski, Jan; Staffurth, John; Syndikus, Isabel; Tree, Alison; Wilkins, Anna; Hall, Emma

Erschienen: American Society of Clinical Oncology (ASCO), 2022

Sprache: Englisch

DOI: 10.1200/jco.2022.40.6_suppl.tps199

ISSN: 0732-183X; 1527-7755

Schlagwörter: Cancer Research ; Oncology

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Beschreibung: TPS199 Background: Optimal management for lymph node (LN) positive prostate cancer has not yet been determined. With the emerging role of PSMA-PET/CT in diagnostic staging, identification of this disease status is increasing. The superior border for prostate nodal radiotherapy is variable across different centres. PEARLS (CRUK/19/016) aims to show that extending the radiotherapy field to cover the para-aortic LN (up to L1/L2 vertebral interspace) can improve outcomes for prostate cancer patients with PSMA-avid pelvic LN at presentation. The trial is registered: ISRCTN36344989. Methods: PEARLS is a multi‐stage randomised controlled trial. Men with histologically confirmed prostate cancer with PSMA‐avid nodal disease within the pelvis +/‐ para‐aortic region receiving androgen deprivation therapy +/‐ androgen receptor targeted therapy or docetaxel chemotherapy are eligible. Two cohorts defined by extent of LN disease determined by PSMA‐PET/CT will be recruited: cohort A (pelvic LN at or below the L4/L5 vertebral interspace) and cohort B (para-aortic LN below L1/L2 vertebral interspace). Patients are randomly allocated (1:1) to standard field (dependent on cohort) intensity modulated radiotherapy (IMRT) (control) or extended-field IMRT (experimental) in 20 fractions over 4 weeks. In the control group, cohort A will receive 60Gy to the prostate and 44Gy to the pelvis with an integrated boost of 51Gy to PSMA-avid LN and cohort B will receive 60Gy to the prostate only. In the experimental group, participants in both cohorts will receive 60Gy to the prostate and 44Gy to the pelvis and para‐aortic region with an integrated boost of 51Gy to involved LN. In phase II, the primary endpoint is lower gastrointestinal RTOG grade 2+ toxicity at week 18 from start of radiotherapy. Assuming acceptable toxicity in the first 75 participants receiving extended-field IMRT, the study will move to phase III where the primary endpoint is metastasis‐free survival. The trial aims to recruit 714 patients with pelvic LN to detect a hazard ratio of 0.62 in favour of extended-field IMRT and a further 179 patients with para‐aortic LN disease. The trial was launched in the UK on 25 June 2021. Phase II will be conducted in 20 NHS Trusts across the UK. Clinical trial information: ISRCTN36344989.

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