This study is to investigate, in a larger cohort of consecutive men, the proportion of abnormal MRI prostate in different phi ranges, and the cancer detected in Chinese men with abnormal MRI. This study aims to evaluate whether MRI prostate can be omitted in men with lower suspicion of prostate cancer.
This is a prospective cohort study recruiting consecutive men with elevated blood test PSA 4-10 ng/mL, normal prostate on digital rectal examination, and result for blood Prostate Health Index (phi) known. A multi-parametric MRI prostate with contrast will be performed in all subjects. MRI prostate will be reported according to PI-RADS (Prostate Imaging-Reporting and Data Systems) v2.1 recommendations\[10\] and scored from 1 to 5. A PI-RADS score of 3-5 is considered abnormal. The proportion of abnormal MRI in different phi ranges (primary outcome) will be compared. The subjects will be offered a prostate biopsy according to usual clinical indications in our hospital: In men with phi \>35 (higher risk of significant prostate cancer), prostate biopsy (systematic biopsy, plus MRI-guided if abnormal MRI) will be offered. In men with phi \< 35 (lower risk of prostate cancer), prostate biopsy (systematic plus MRI-guided) will be offered only if MRI is abnormal.
Study Type
OBSERVATIONAL
Enrollment
159
Prince of Wales Hospital, Chinese University of Hong Kong
Hong Kong, Hong Kong
In men with higher risk of significant prostate cancer, proportion of men with abnormal MRI at different Prostate Health Index (phi) ranges
In men with higher risk (phi\>35) of significant prostate cancer), proportion of men with abnormal MRI.
Time frame: Baseline (only one-time point)
In men with lower risk of significant prostate cancer, proportion of men with abnormal MRI at different Prostate Health Index (phi) ranges
In men with lower risk (phi\<35) of significant prostate cancer), proportion of men with abnormal MRI.
Time frame: Baseline (only one-time point)
Sensitivity of various phi cutoffs to predict PI-RADS score ≥3 in MRI prostate
Assessed by phi values and PI-RADS score in MRI prostate
Time frame: Baseline (only one-time point)
Sensitivity of various phi cutoffs to predict PI-RADS score ≥4 in MRI prostate
Assessed by phi values and PI-RADS score in MRI prostate
Time frame: Baseline (only one-time point)
Proportion of low risk group diagnosis of clinically significant prostate cancer with abnormal MRI
Diagnosis of clinically significant prostate cancer (Gleason 3+4 or above) in men with abnormal MRI and phi \<35
Time frame: Baseline (only one-time point)
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