Journal article

UpFrontPSMA: a randomized phase 2 study of sequential Lu-177-PSMA-617 and docetaxel vs docetaxel in metastatic hormone-naive prostate cancer (clinical trial protocol)

Nattakorn Dhiantravan, Louise Emmett, Anthony M Joshua, David A Pattison, Roslyn J Francis, Scott Williams, Shahneen Sandhu, Ian D Davis, Ian Vela, Nitika Neha, Mathias Bressel, Declan G Murphy, Michael S Hofman, Arun A Azad

BJU INTERNATIONAL | WILEY | Published : 2021

Abstract

OBJECTIVE: To assess the activity and safety of sequential lutetium-177 (177 Lu)-PSMA-617 and docetaxel vs docetaxel on a background of androgen deprivation therapy (ADT) in men with de novo metastatic hormone-naïve prostate cancer (mHNPC). PATIENTS AND METHODS: UpFrontPSMA (NCT04343885) is an open-label, randomized, multicentre, phase 2 trial, recruiting 140 patients at 12 Australian centres. Key eligibility criteria include: prostate cancer with a histological diagnosis within 12 weeks of screening commencement; prostate-specific antigen (PSA) >10 ng/mL at diagnosis; ≤4 weeks on ADT; evidence of metastatic disease on computed tomography (CT) and/or bone scan; high-volume prostate-specific ..

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Grants

Awarded by NHMRC Practitioner Fellowship


Funding Acknowledgements

We thank Annette Van Der Heyden, programme manager at the Prostate Cancer Theranostics and Imaging Centre of Excellence (ProsTIC), and Mark Scalzo, lead nuclear medicine technologist at ProsTIC. We also thank ARTnet for contributing to radiopharmaceutical and PET camera quality control accreditation. Dr Nattakorn Dhiantravan is a recipient of the 2020 RACP Arnott Research Entry Scholarship in Cancer Research. Prof. Michael Hofman receives support from Prostate Cancer Foundation (PCF) as director of ProsTIC; this is supported by CANICA AS, Oslo, Norway. Prof. Ian D. Davis is supported by an NHMRC Practitioner Fellowship (APP1102604).This clinical trial is funded by a Prostate Cancer Research Alliance grant from the Movember Foundation, the Australian Government Medical Research Future Fund, and a US Department of Defence Impact Award-Clinical Trials to the Peter MacCallum Cancer Centre. Endocyte/Advanced Accelerator Applications (AAA), the radioligand business of Novartis, manufacturer of PSMA-617, are providing supply and financial support. 177Lu is being purchased from the Australian Nuclear Science and Technology Organisation (ANSTO).