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Simple Summary: The study provides a predictive model by using clinical factors in selecting men who may benefit from the addition of systematic biopsies with an image fusion targeted approach. The approach is likely to improve the detection of csPCa and avoid unnecessary detection of indolent prostate cancers. The study was aimed to develop a predictive model to identify patients who may benefit from performing systematic random biopsies (SB) in addition to targeted biopsies (TB) in men suspected of having prostate cancer. A total of 198 patients with positive pre-biopsy MRI findings and who had undergone both TB and SB were prospectively recruited into this study. The primary outcome was detection rates of clinically significant prostate cancer (csPCa) in SB and TB approaches. The secondary outcome was net clinical benefits of SB in addition to TB. A logistic regression model and nomogram construction were used to perform a multivariate analysis. The detection rate of csPCa using SB was 51.0% (101/198) compared to a rate of 56.1% (111/198) for TB, using a patient-based biopsy approach. The detection rate of csPCa was higher using a combined biopsy (64.6%; 128/198) in comparison to TB (56.1%; 111/198) alone. This was statistically significant (p < 0.001). Age, PSA density and PIRADS score significantly predicted the detection of csPCa by SB in addition to TB. A nomogram based on the model showed good discriminative ability (C-index; 78%). The decision analysis curve confirmed a higher net clinical benefit at an acceptable threshold. [ABSTRACT FROM AUTHOR]

Background: There is growing evidence suggesting that multiparametric magnetic resonance imaging (mpMRI) is a marker for prostate cancer (PCa) aggressiveness and could be used to plan treatment. Improving early detection of clinically significant PCa with pre-biopsy mpMRI would very likely have advantages including optimising the diagnosis and treatment of diseases and diminishing patient anxiety.Methods and Materials: This is a prospective multicentre study of pre-biopsy mpMRI diagnostic test accuracy with subgroup randomisation at a 1:1 ratio with respect to transrectal ultrasound (TRUS) and MRI/US fusion-guided biopsy or TRUS-only biopsy. It is designed as a single-gate study with a single set of inclusion criteria. The total duration of the recruitment phase was 48 months; however, this has now been extended to 66 months. A sample size of 600 participants is required.Discussion: The primary objective is to determine whether mpMRI can improve PCa detection and characterisation. The key secondary objective is to determine whether MRI/US fusion-guided biopsy can reduce the number of false-negative biopsies. Ethical approval was obtained from the East of Scotland Research Ethics Committee 1 (14/ES/1070) on 20 November 2014. The results of this study will be used for publication and presentation in national and international journals and at scientific conferences.Trial Registration: ClinicalTrials.gov, NCT02745496. Retrospectively registered on 20 April 2016. [ABSTRACT FROM AUTHOR]