Evaluation of Proclarix, a prostate cancer risk score, used together with magnetic resonance imaging for the diagnosis of clinically significant prostate cancer.

2020 ◽  
Vol 38 (6_suppl) ◽  
pp. 278-278
Author(s):  
Hayley Pye ◽  
Hashim Ahmed ◽  
Susan Heavey ◽  
Urszula Stopka-Farooqui ◽  
Edward Johnston ◽  
...  
Keyword(s):  
Magnetic Resonance Imaging ◽  
Prostate Cancer ◽  
Magnetic Resonance ◽  
Risk Score ◽  
Prostate Cancer Risk ◽  
Significant Advance ◽  
Resonance Imaging ◽  
Grade Group ◽  
Group 2 ◽  
Clinically Significant

278 Background: The use of multi-parametric magnetic resonance imaging (mpMRI) has been a significant advance in the diagnosis of prostate cancer (PCa) recommended in a number of guidelines. There are considerable resource implications in scanning all men at risk of PCa. Furthermore, a significant number of mpMRIs are reported as indeterminate, leading to unnecessary biopsies. Proclarix is a CE-marked test based on two novel biomarkers, thrombospondin 1 (THBS1) and cathepsin D (CTSD), combined with PSA and age. A software algorithm returns a risk score that can be used as an aid in the identification of clinically significant PCa (any Grade Group 2 or greater). We aimed to assess the potential of Proclarix to identify those men who could safely avoid an upfront mpMRI or those men who could avoid biopsy when the mpMRI was indeterminate. Methods: Proclarix was correlated retrospectively with diagnostic data from 282 men recruited in the INNOVATE study (NCT02689271). INNOVATE involved men undergoing mpMRI followed by targeted and systematic biopsies in those with a suspicious mpMRI. Results: Median age and PSA were 66 (IQR 59-70) and 5.4 (3.8-7.8) ng/mL. 182 (65%) men underwent biopsy and 78 (43%) had GG≥2 PCa. Application of Proclarix in all 282 men undergoing mpMRI resulted in a sensitivity for clinically significant PCa (GG≥2) of 91%, a negative predictive value (NPV) of 92% and 38% specificity. When normalized to the same sensitivity of 91%, %fPSA resulted in both lower NPV (89%) and specificity (28%) when compared to Proclarix. 144 (51%) men had an indeterminate mpMRI of whom 84 (58%) had a biopsy and 13 (15%) had GG≥2 PCa. In these men, Proclarix had an NPV of 100%, at 100% sensitivity and a specificity of 34%. When results were compared using equal sensitivity, PSA density (cut-off 0.05 ng/mL), which is frequently used to inform the need for biopsy, had 10% specificity. Conclusions: The use of Proclarix could potentially allow 38% of men to avoid undergoing an mpMRI. In men with an indeterminate mpMRI, Proclarix could allow one-third to safely avoid biopsies without missing any clinically significant cancer.

Naive patients with suspicious prostate cancer and positive multiparametric magnetic resonance imaging (mp-MRI): is it time for fusion target biopsy alone?

2021 ◽  
pp. 205141582110237
Author(s):  
Enrico Checcucci ◽  
Sabrina De Cillis ◽  
Daniele Amparore ◽  
Diletta Garrou ◽  
Roberta Aimar ◽  
...  
Keyword(s):  
Magnetic Resonance Imaging ◽  
Prostate Cancer ◽  
Magnetic Resonance ◽  
Detection Rate ◽  
Resonance Imaging ◽  
Fusion Biopsy ◽  
Grade Group ◽  
Final Pathology ◽  
Multiparametric Magnetic Resonance Imaging ◽  
Clinically Significant

Objectives: To determine if standard biopsy still has a role in the detection of prostate cancer or clinically significant prostate cancer in biopsy-naive patients with positive multiparametric magnetic resonance imaging. Materials and methods: We extracted, from our prospective maintained fusion biopsy database, patients from March 2014 to December 2018. The detection rate of prostate cancer and clinically significant prostate cancer and complication rate were analysed in a cohort of patients who underwent fusion biopsy alone (group A) or fusion biopsy plus standard biopsy (group B). The International Society of Urological Pathology grade group determined on prostate biopsy with the grade group determined on final pathology among patients who underwent radical prostatectomy were compared. Results: Prostate cancer was found in 249/389 (64.01%) and 215/337 (63.8%) patients in groups A and B, respectively ( P=0.98), while the clinically significant prostate cancer detection rate was 57.8% and 55.1% ( P=0.52). No significant differences in complications were found. No differences in the upgrading rate between biopsy and final pathology finding after radical prostatectomy were recorded. Conclusions: In biopsy-naive patients, with suspected prostate cancer and positive multiparametric magnetic resonance imaging the addition of standard biopsy to fusion biopsy did not increase significantly the detection rate of prostate cancer or clinically significant prostate cancer. Moreover, the rate of upgrading of the cancer grade group between biopsy and final pathology was not affected by the addition of standard biopsy. Level of evidence: Not applicable for this multicentre audit.

One-year experience of government-funded magnetic resonance imaging prior to prostate biopsy: A case for omitting biopsy in men with a negative magnetic resonance imaging

2021 ◽  
pp. 205141582110043
Author(s):  
Hanna J El-Khoury ◽  
Niranjan J Sathianathen ◽  
Yuxin Jiao ◽  
Reza Farzan ◽  
Dennis Gyomber ◽  
...  
Keyword(s):  
Magnetic Resonance Imaging ◽  
Prostate Cancer ◽  
Magnetic Resonance ◽  
Prostate Biopsy ◽  
Multivariable Analysis ◽  
Transrectal Ultrasound ◽  
Resonance Imaging ◽  
Retrospective Case ◽  
Level Of Evidence ◽  
Clinically Significant

Objectives: This study aimed to characterise the accuracy of multiparametric magnetic resonance imaging (mpMRI) as an adjunct to prostate biopsy, and to assess the effect of the new Australian Medicare rebate on practice at a metropolitan public hospital. Patients and methods: We identified patients who underwent transrectal ultrasound (TRUS)-guided prostate biopsy at a single institution over a two-year period. Patients were placed into two groups, depending upon whether their consent was obtained before or after the introduction of the Australian Medicare rebate for mpMRI. We extracted data on mpMRI results and TRUS-guided biopsy histopathology. Descriptive statistics were used to demonstrate baseline patient characteristics as well as MRI and histopathology results. Results: A total of 252 patients were included for analysis, of whom 128 underwent biopsy following the introduction of the Medicare rebate for mpMRI. There was a significant association between Prostate Imaging Reporting and Data System v2 (PI-RADS) classification and the diagnosis of clinically significant prostate cancer ( p<0.01). Only one man with PI-RADS ⩽2 was found to have clinically significant prostate cancer. Four men with a PI-RADS 3 lesion were found to have clinically significant cancer. A PI-RADS 4 or 5 lesion was significantly associated with the diagnosis of clinically significant cancer on multivariable analysis. Conclusion: mpMRI is an important adjunct to biopsy in the diagnosis of clinically significant prostate cancer. Our findings support the safety of omitting/delaying prostate biopsy in men with negative mpMRI. Level of evidence: Level 3 retrospective case-control study.

Magnetic Resonance Imaging–Based Prediction of Prostate Cancer Risk

JAMA Oncology ◽  
2018 ◽  
Vol 4 (11) ◽  
pp. 1624
Author(s):  
Giampaolo Bianchi ◽  
Maria Chiara Sighinolfi ◽  
Bernardo Rocco
Keyword(s):  
Magnetic Resonance Imaging ◽  
Prostate Cancer ◽  
Magnetic Resonance ◽  
Cancer Risk ◽  
Prostate Cancer Risk ◽  
Resonance Imaging
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