Novel biparametric MRI and targeted biopsy improves risk stratification in men with a clinical suspicion of prostate cancer (IMPROD Trial).
To evaluate the role of a 3T biparametric magnetic resonance imaging (bpMRI), T2-weighted imaging, and three separate diffusion-weighted imaging acquisitions combined with targeted biopsy (TB) for improving risk stratification of men with elevated prostate-specific antigen (PSA).



Between March 2013 and February 2015, 175 men with a clinical suspicion of prostate cancer (PCa) were offered bpMRI (NCT01864135) based on a suspicion of PCa (two repeated PSA measurements in the range 2.5-20.0 ng/ml and/or abnormal digital rectal examination). Men with an equivocal to high suspicion of PCa had two TBs of the dominant lesion using cognitive ultrasound guidance, followed by systematic biopsy (SB). Men with a low to very low suspicion had only SB. In total, 161 (161/175, 92%) prospectively enrolled men completed the trial and were included in the final analyses. The primary endpoint of the trial was the cancer detection rate (CDR) of TB and SB. Clinically significant cancer (SPCa) was defined as Gleason score ≥3 + 4.



TB compared with SB had higher CDR for SPCa (45%, 72/161 vs. 39%, 63/161, respectively; P > 0.05) and a lower CDR for Gleason score 3 + 3 (8%, 15/161 vs. 16%, 30/161; P < 0.05). Restricting biopsy to men with equivocal to highly suspicious bpMRI findings would have resulted in a 24% (38/161) reduction in the number of men undergoing biopsy, while missing 4 (2%) with SPCa. All anonymized datasets, including bpMRI reports and follow up information, are freely available on the trial server.



Prebiopsy bpMRI and TB in men with a clinical suspicion of PCa improved risk stratification.



1 Technical Efficacy: Stage 5 J. Magn. Reson. Imaging 2017;46:1089-1095.
Department of Diagnostic Radiology, University of Turku, Turku, Finland.|Medical Imaging Centre of Southwest Finland, Turku University Hospital, Turku, Finland.
Ivan
I
Jambor
Department of Urology, Turku University Hospital, Turku, Finland.
Peter J
PJ
Boström
Department of Pathology, University of Turku and Turku University Hospital, Turku, Finland.
Pekka
P
Taimen
Department of Urology, Turku University Hospital, Turku, Finland.
Kari
K
Syvänen
Department of Urology, Turku University Hospital, Turku, Finland.
Esa
E
Kähkönen
Department of Pathology, University of Turku and Turku University Hospital, Turku, Finland.
Markku
M
Kallajoki
Department of Diagnostic Radiology, University of Turku, Turku, Finland.|Medical Imaging Centre of Southwest Finland, Turku University Hospital, Turku, Finland.|Department of Information Technology, University of Turku, Turku, Finland.
Ileana Montoya
IM
Perez
Department of Biostatistics, University of Turku, Turku, Finland.
Tommi
T
Kauko
Department of Biostatistics, University of Turku, Turku, Finland.
Jaakko
J
Matomäki
Department of Biostatistics, University of Turku, Turku, Finland.
Otto
O
Ettala
Department of Diagnostic Radiology, University of Turku, Turku, Finland.|Medical Imaging Centre of Southwest Finland, Turku University Hospital, Turku, Finland.|Department of Information Technology, University of Turku, Turku, Finland.
Harri
H
Merisaari
Department of Diagnostic Radiology, University of Turku, Turku, Finland.|Medical Imaging Centre of Southwest Finland, Turku University Hospital, Turku, Finland.
Aida
A
Kiviniemi
Department of Diagnostic Radiology, University of Turku, Turku, Finland.|Medical Imaging Centre of Southwest Finland, Turku University Hospital, Turku, Finland.
Peter B
PB
Dean
Department of Diagnostic Radiology, University of Turku, Turku, Finland.|Medical Imaging Centre of Southwest Finland, Turku University Hospital, Turku, Finland.
Hannu J
HJ
Aronen
D006801:Humans; D061705:Image-Guided Biopsy; D008279:Magnetic Resonance Imaging / Q000379:methods*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011467:Prostate / Q000000981:diagnostic imaging; D011471:Prostatic Neoplasms / Q000000981:diagnostic imaging* / Q000473:pathology*; D015203:Reproducibility of Results; D018570:Risk Assessment
PSA; biparametric MRI; diffusion weighted imaging; prostate cancer