PSMA PET/CT guided intensification of therapy in patients at risk of advanced prostate cancer (PATRON): a pragmatic phase III randomized controlled trial

Cynthia Ménard, Sympascho Young, Katherine Zukotynski, Robert J Hamilton, François Bénard, Steven Yip, Christopher McCabe, Fred Saad, Michael Brundage, Roy Nitulescu, Glenn Bauman, Cynthia Ménard, Sympascho Young, Katherine Zukotynski, Robert J Hamilton, François Bénard, Steven Yip, Christopher McCabe, Fred Saad, Michael Brundage, Roy Nitulescu, Glenn Bauman

Abstract

Background: Positron emission tomography targeting the prostate specific membrane antigen (PSMA PET/CT) has demonstrated unparalleled performance as a staging examination for prostate cancer resulting in substantial changes in management. However, the impact of altered management on patient outcomes is largely unknown. This study aims to assess the impact of intensified radiotherapy or surgery guided by PSMA PET/CT in patients at risk of advanced prostate cancer.

Methods: This pan-Canadian phase III randomized controlled trial will enroll 776 men with either untreated high risk prostate cancer (CAPRA score 6-10 or stage cN1) or biochemically recurrent prostate cancer post radical prostatectomy (PSA > 0.1 ng/mL). Patients will be randomized 1:1 to either receive conventional imaging or conventional plus PSMA PET imaging, with intensification of radiotherapy or surgery to newly identified disease sites. The primary endpoint is failure free survival at 5 years. Secondary endpoints include rates of adverse events, time to next-line therapy, as well as impact on health-related quality of life and cost effectiveness as measured by incremental cost per Quality Adjusted Life Years gained.

Discussion: This study will help create level 1 evidence needed to demonstrate whether or not intensification of radiotherapy or surgery based on PSMA PET findings improves outcomes of patients at risk of advanced prostate cancer in a manner that is cost-effective.

Trial registration: This trial was prospectively registered in ClinicalTrials.gov as NCT04557501 on September 21, 2020.

Keywords: Cost-effectiveness analysis; Failure free survival; Overall survival; PSMA PET; Phase III clinical trial; Prostate cancer; Radiotherapy; Superiority.

Conflict of interest statement

KZ is a consultant for: Invicro, General Electric, Jubilant DraxImage and the Centre for Probe Development and Commercialization.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
General study schema. (CI = conventional imaging)
Fig. 2
Fig. 2
Schema for intensification of therapy by PSMA PET findings (CI = conventional imaging)

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