Ugo Giovanni Falagario1, Ivan Jambor2, Anna Lantz3, Otto Ettala4, Armando Stabile5, Pekka Taimen6, Hannu J Aronen7, Juha Knaapila4, Ileana Montoya Perez7, Giorgio Gandaglia5, Nicola Fossati5, Alberto Martini8, Vito Cucchiara5, Wolfgang Picker9, Erik Haug10, Parita Ratnani11, Kenneth Haines12, Sara Lewis13, Nair Sujit11, Oscar Selvaggio14, Francesca Sanguedolce15, Luca Macarini16, Luigi Cormio17, Tobias Nordström18, Ash Tewari11, Alberto Briganti5, Peter J Boström4, Giuseppe Carrieri14. 1. Department of Urology and Organ Transplantation, University of Foggia, Foggia, Italy; Department of Urology, Icahn School of Medicine at Mount Sinai, New York, NY, USA. Electronic address: ugofalagario@gmail.com. 2. Department of Radiology, Icahn School of Medicine at Mount Sinai, New York, NY, USA; Department of Radiology, University of Turku, Turku, Finland; Medical Imaging Centre of Southwest Finland, Turku University Hospital, Turku, Finland. 3. Department of Urology, Icahn School of Medicine at Mount Sinai, New York, NY, USA; Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden; Department of Urology, Karolinska University Hospital, Solna, Sweden. 4. Department of Urology, University of Turku and Turku University Hospital, Turku, Finland. 5. Department of Oncology/Unit of Urology, Urological Research Institute, IRCCS Ospedale San Raffaele, Milan, Italy. 6. Institute of Biomedicine, University of Turku, Turku, Finland; Department of Pathology, Turku University Hospital, Turku, Finland. 7. Department of Radiology, University of Turku, Turku, Finland; Medical Imaging Centre of Southwest Finland, Turku University Hospital, Turku, Finland. 8. Department of Urology, Icahn School of Medicine at Mount Sinai, New York, NY, USA; Department of Oncology/Unit of Urology, Urological Research Institute, IRCCS Ospedale San Raffaele, Milan, Italy. 9. Department of Radiology, Aleris Cancer Center, Oslo, Norway. 10. Section of Urology, Vestfold Hospital Trust, Tønsberg, Norway. 11. Department of Urology, Icahn School of Medicine at Mount Sinai, New York, NY, USA. 12. Department of Pathology, Icahn School of Medicine at Mount Sinai, New York, NY, USA. 13. Department of Radiology, Icahn School of Medicine at Mount Sinai, New York, NY, USA. 14. Department of Urology and Organ Transplantation, University of Foggia, Foggia, Italy. 15. Department of Pathology, University of Foggia, Foggia, Italy. 16. Department of Radiology, University of Foggia, Foggia, Italy. 17. Department of Urology and Organ Transplantation, University of Foggia, Foggia, Italy; Department of Urology, Bonomo Teaching Hospital, Andria, Italy. 18. Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden; Department of Urology, Karolinska University Hospital, Solna, Sweden.
Abstract
BACKGROUND: Previous studies suggested that prostate-specific antigen (PSA) density (PSAd) combined with magnetic resonance imaging (MRI) may help avoid unnecessary prostate biopsy (PB) with a limited risk of missing clinically significant prostate cancer (csPCa; Gleason grade group [GGG] >1). OBJECTIVE: To define optimal diagnostic strategies based on the combined use of PSAd and MRI in patients at risk of prostate cancer (PCa). DESIGN, SETTING, AND PARTICIPANTS: A retrospective analysis of the international multicenter Prostate MRI Outcome Database (PROMOD), including 2512 men having undergone PSAd and prostate MRI before PB between 2013 and 2019, was performed. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Rates of avoided PB, missed GGG 1, and csPCa according to 10 strategies based on PSAd values and MRI reporting scores (Prostate Imaging Reporting and Data System [PI-RADS]/Likert/IMPROD biparametric prostate MRI Likert). Decision curve analysis (DCA) was used to statistically compare the net benefit of each strategy. Combined systematic and targeted biopsies were used for reference. RESULTS AND LIMITATIONS: According to DCA, the best strategy in biopsy-naive patients was #7 (PI-RADS/Likert 4-5 or PI-RADS/Likert 3 if PSAd >0.2), which avoided 41.2% PBs while missed 44% of GGG 1 and 10.9% of csPCa cases. From a clinical standpoint, however, strategies with a lower risk of missing csPCa included #10 (PI-RADS/Likert 4-5 or PI-RADS 3 if PSAd >0.10 or PSAd >0.2), which avoided 27% PBs while missing 24.4% GGG 1 and 4% csPCa cases, or #5 (PI-RADS/Likert 3-5 or PSAd>0.15), which avoided 14.7% PBs while missing 9.3% GGG 1 and 1.7% csPCa cases. Similar results were found in patients with a previous negative biopsy. This study is limited by its retrospective nature, and no central review of MRI and histopathological findings. CONCLUSIONS: Combined PSAd and MRI findings allows individualization of the decision to perform PB on the basis of the risk of missing PCa that both patients and clinicians are ready to accept to avoid this procedure. PATIENT SUMMARY: We compared several biopsy strategies based on a combination of prostate magnetic resonance imaging findings and prostate-specific antigen density, providing a readily available tool for each center and practicing urologist to counsel patients about their individual risk of significant prostate cancer.
BACKGROUND: Previous studies suggested that prostate-specific antigen (PSA) density (PSAd) combined with magnetic resonance imaging (MRI) may help avoid unnecessary prostate biopsy (PB) with a limited risk of missing clinically significant prostate cancer (csPCa; Gleason grade group [GGG] >1). OBJECTIVE: To define optimal diagnostic strategies based on the combined use of PSAd and MRI in patients at risk of prostate cancer (PCa). DESIGN, SETTING, AND PARTICIPANTS: A retrospective analysis of the international multicenter Prostate MRI Outcome Database (PROMOD), including 2512 men having undergone PSAd and prostate MRI before PB between 2013 and 2019, was performed. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Rates of avoided PB, missed GGG 1, and csPCa according to 10 strategies based on PSAd values and MRI reporting scores (Prostate Imaging Reporting and Data System [PI-RADS]/Likert/IMPROD biparametric prostate MRI Likert). Decision curve analysis (DCA) was used to statistically compare the net benefit of each strategy. Combined systematic and targeted biopsies were used for reference. RESULTS AND LIMITATIONS: According to DCA, the best strategy in biopsy-naive patients was #7 (PI-RADS/Likert 4-5 or PI-RADS/Likert 3 if PSAd >0.2), which avoided 41.2% PBs while missed 44% of GGG 1 and 10.9% of csPCa cases. From a clinical standpoint, however, strategies with a lower risk of missing csPCa included #10 (PI-RADS/Likert 4-5 or PI-RADS 3 if PSAd >0.10 or PSAd >0.2), which avoided 27% PBs while missing 24.4% GGG 1 and 4% csPCa cases, or #5 (PI-RADS/Likert 3-5 or PSAd>0.15), which avoided 14.7% PBs while missing 9.3% GGG 1 and 1.7% csPCa cases. Similar results were found in patients with a previous negative biopsy. This study is limited by its retrospective nature, and no central review of MRI and histopathological findings. CONCLUSIONS: Combined PSAd and MRI findings allows individualization of the decision to perform PB on the basis of the risk of missing PCa that both patients and clinicians are ready to accept to avoid this procedure. PATIENT SUMMARY: We compared several biopsy strategies based on a combination of prostate magnetic resonance imaging findings and prostate-specific antigen density, providing a readily available tool for each center and practicing urologist to counsel patients about their individual risk of significant prostate cancer.
Authors: Sneha Parekh; Parita Ratnani; Ugo Falagario; Dara Lundon; Deepshikha Kewlani; Jordan Nasri; Zach Dovey; Dimitrios Stroumbakis; Daniel Ranti; Ralph Grauer; Stanislaw Sobotka; Adriana Pedraza; Vinayak Wagaskar; Lajja Mistry; Ivan Jambor; Anna Lantz; Otto Ettala; Armando Stabile; Pekka Taimen; Hannu J Aronen; Juha Knaapila; Ileana Montoya Perez; Giorgio Gandaglia; Alberto Martini; Wolfgang Picker; Erik Haug; Luigi Cormio; Tobias Nordström; Alberto Briganti; Peter J Boström; Giuseppe Carrieri; Kenneth Haines; Michael A Gorin; Peter Wiklund; Mani Menon; Ash Tewari Journal: Eur Urol Open Sci Date: 2022-05-20
Authors: Ugo Giovanni Falagario; Giovanni Silecchia; Salvatore Mariano Bruno; Michele Di Nauta; Mario Auciello; Francesca Sanguedolce; Paola Milillo; Luca Macarini; Oscar Selvaggio; Giuseppe Carrieri; Luigi Cormio Journal: Front Oncol Date: 2021-01-08 Impact factor: 6.244
Authors: Ugo Giovanni Falagario; Gian Maria Busetto; Giuseppe Stefano Netti; Francesca Sanguedolce; Oscar Selvaggio; Barbara Infante; Elena Ranieri; Giovanni Stallone; Giuseppe Carrieri; Luigi Cormio Journal: Cancers (Basel) Date: 2021-03-31 Impact factor: 6.639