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The Lancet

Oncology

Lu]Lu-PSMA-617 versus cabazitaxel in metastatic castration-resistant prostate cancer (TheraP): secondary outcomes of a randomised, open-label, phase 2 trial.

Last Revised:
PMID: 38043558
PII: S1470-2045(23)00529-6
PII: S1470-2045(23)00529-6

Summary

The study involved a clinical trial investigating the effectiveness of F]FDG PET-CT on prostate cancer patients. The trial, which is registered with ClinicalTrials.gov (NCT03392428) and is now complete, implemented a treatment cycle every 3 weeks with a maximum of ten cycles. The overall survival was evaluated by intention-to-treat and restricted mean survival time (RMST) was used to account for non-proportional hazards, with a 36-month restriction time corresponding to median follow-up. Out of 61 patients with available follow-up, RMST was 11·0 months (95% CI 9·0 to 13·1). The trial was funded by several organizations including the Australian and New Zealand Urogenital and Prostate Cancer Trials Group, Prostate Cancer Foundation of Australia, Endocyte (a Novartis company), and others.

Key Takeaways

  • The clinical trial involved a treatment cycle every 3 weeks for prostate cancer patients using F]FDG PET-CT.
  • The overall survival was analysed using the intention-to-treat method and RMST, with a 36-month restriction time.
  • Out of 61 patients with follow-up data, the RMST was found to be 11·0 months.

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Authors

Michael S Hofman, Louise Emmett, Shahneen Sandhu, Amir Iravani, James P Buteau, Anthony M Joshua, Jeffrey C Goh, David A Pattison, Thean Hsiang Tan, Ian D Kirkwood, Siobhan Ng, Roslyn J Francis, Craig Gedye, Natalie K Rutherford, Andrew Weickhardt, Andrew M Scott, Sze-Ting Lee, Edmond M Kwan, Arun A Azad, Shakher Ramdave, Andrew D Redfern, William Macdonald, Alex Guminski, Edward Hsiao, Wei Chua, Peter Lin, Alison Yan Zhang, Martin R Stockler, Scott G Williams, Andrew J Martin, Ian D Davis,

Full Abstract

  • BACKGROUND: F]FDG) PET-CT.
  • METHODS: every 3 weeks, maximum of ten cycles). Overall survival was analysed by intention-to-treat and summarised as restricted mean survival time (RMST) to account for non-proportional hazards, with a 36-month restriction time corresponding to median follow-up. This trial is registered with ClinicalTrials.gov, NCT03392428, and is complete.
  • FINDINGS: F]FDG PET. In the 61 of these men with follow-up available, RMST was 11·0 months (95% CI 9·0 to 13·1).
  • INTERPRETATION: F]FDG-discordant disease.
  • FUNDING: Australian and New Zealand Urogenital and Prostate Cancer Trials Group, Prostate Cancer Foundation of Australia, Endocyte (a Novartis company), Australian Nuclear Science and Technology Organization, Movember, It's a Bloke Thing, CAN4CANCER, and The Distinguished Gentleman's Ride.

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