He starts by reviewing prior prostate cancer screening strategies, including PSA testing alone from the ERSPC trial, MRI with targeted biopsy alone from the UK, and PSA and MRI with targeted biopsy in the Goteborg 2 study. The PROSCREEN study builds on these prior studies by utilizing PSA, 4Kscore, and MRI.
The PROSCREEN study is a population-based randomized screen trial initiated in 2018. The accrual goal was 60,784 men from Finland. It allowed for a flexible screening interval – if baseline PSA < 1.5, men were invited back after 6 years. If between 1.5-3.0, screening interval 4 years. If PSA >3.0 (screen-positive), re-screened after 2 years.
Their expected performance of the screening tests, specifically to reduce the number of patients requiring biopsy and ultimately diagnosed with prostate cancer, is shown below:
They ultimately hoped to reduced biopsies by about 55%. In men, who were diagnosed with prostate cancer, they expected <50% to have GG1 prostate cancer and more than 33% to have GG3+ prostate cancer.
While recruitment started in 2018, there were some delays due to COVID 19. So far they’ve obtained consent in approximately 5400 men. MRI has been performed in over 300 men while biopsy is performed in over 100. Compliance appears to be greater than 98%.
They have no preliminary results to present today. Their next steps are as follow:
- Evaluation of first-round results, including cancer detection and overdiagnosis
- Case-control Analysis of novel prostate cancer markers based on first-round cases and controls
- vfollow up for cancer incidence and mortality, specifically missed cancers in the screening arm and comparison of incidence by arm.
- vMain endpoint is mortality for prostate cancer initially at 10 years with the final analysis of 15 years. This is naturally expected to take some time. Over 500 prostate cancer specific deaths are expected.
Presented by: Anssi P. Auvinen, MD, PhD, University of Tampere, Tampere, Finland
Written by: Thenappan (Thenu) Chandrasekar, MD – Urologic Oncologist, Assistant Professor of Urology, Sidney Kimmel Cancer Center, Thomas Jefferson University, @tchandra_uromd on Twitter during the 2021 European Association of Urology, EAU 2021- Virtual Meeting, July 8-12, 2021.