PROPHET is a prospective study in order to clarify a diagnostic impact of laboratory-based and prostate volume-adjusted [-2]proPSA-related indices on prostate cancer and a clinically significant prostate cancer in the PSA below 10 ng/mL.

Between April 2015 and March 2017, 421 men aged 50 to 79 in the PSA range above age-specific cut-offs and below 10 ng/mL were registered in the PROPHET. Diagnostic impacts of various clinical laboratory-based free PSA-related and [-2]proPSA-related indices on any grade and high Gleason grade group prostate cancer were investigated.

Out of 363 eligible participants, 179, 141 and 80 were diagnosed with any grade prostate cancer, Gleason grade group 2-5 and 3-5 prostate cancer, respectively. The AUC-ROC distinguishing non-prostate cancer vs prostate cancer, non-prostate cancer + low Gleason Grade Group and low volume vs remaining prostate cancer with higher Gleason Grade group or higher volume for phi were significantly superior to PSA and free/total PSA. The false positive rate at 90% sensitivity in all investigated [-2]proPSA-related indices were superior to those in PSA and free/total PSA in any grouping comparisons in terms of Gleason grade group and positive biopsy cores. phi would avoid unnecessary biopsy in 35 to 42% of men without prostate cancer and/or those with less aggressive prostate cancer.

Laboratory-based [-2]proPSA-related indices were significantly superior in detecting clinically significant prostate cancer compared to free/total PSA and those would avoid up to 42% of prostate biopsy in men without aggressive cancer in the setting for maintaining 90% sensitivity.

The Journal of urology. 2019 Aug 20 [Epub ahead of print]

Kazuto Ito, Akira Yokomizo, Shoji Tokunaga, Gaku Arai, Mikio Sugimoto, Koichiro Akakura, Hisashi Hasumi, Hideki Sakai, Akiko Ouraji, Ryo Oki, Eiji Kashiwagi, Yoshitomo Kobori, Hiromi Hirama, Hiroki Kitoh, Hiroji Uemura, Tomoaki Hakariya, Kazuhiro Suzuki, members of PROPHET

Department of Urology, Gunma University Graduate School of Medicine., Department of Urology, Graduate School of Medical Sciences, Kyushu University., Medical Information Center, Kyushu University Hospital., Department of Urology, Dokkyo Medical University Saitama Medical Center., Department of Urology, Kagawa University Faculty of Medicine., Department of Urology, JCHO Tokyo Shinjuku Medical Center., Department of Urology, Yokohama City University., Department of Urology, Nagasaki University Graduate School of Biomedical Sciences., Clinical Research Support Center Kyushu., Institute for Preventive Medicine, Kurosawa Hospital, Gunma, Japan.