Plenary: Next Frontier, Sunday, Afternoon Session
Presentation Authors: Rajiv Jayadevan*, Fuad Elkhoury, Ely Felker, Lorna Kwan, Anthony Sisk, Merdie Delfin, Shyam Natarajan, Leonard Marks, Los Angeles, CA
Introduction: Herein is presented final results of a paired-cohort trial (PAIREDCAP), in which cancer-detection rates (CDR) of software-targeted, cognitive-targeted, and systematic biopsies are compared, with each man serving as his own control. Such data are lacking and may help direct future use of MRI-guided biopsy.
Methods: Subjects were 300 men undergoing first-time prostate biopsy. A powered sample of 248 consecutive men with MRI-visible lesions (PIRADS v2 ≥ 3) underwent all 3 biopsy methods at the same session: first, 12-core systematic biopsy; second, MRI-lesion targeted cognitively; third, MRI-lesion targeted by software fusion. Most lesions were PIRADS Grade 4 or 5 (192/248, 78%); 38% were anterior. A comparison group of 52 men with negative mpMRI underwent systematic biopsy only. The primary endpoint was CDR of clinically significant prostate cancer (csCaP: Gleason ≥ 3+4).
Results:In the paired cohort, CDR was 47% for cognitive targeting, 60% for systematic sampling, and 62% for software targeting. The overall CDR was 70% (178/248) when systematic and targeting methods were combined. 11%-33% of cases would have been missed by using a single biopsy method. CDR was directly related to PIRADS grade (grade 3, 23%; grade 4, 64%; and grade 5, 80% p<0.01). Men with PSA density (PSAD) ≥ 0.15 had a three-fold risk of csCaP as those with PSAD <0.10. Within PIRADS grades and PSAD strata, CDR was similar between biopsy methods. CDR was 15% (8/52) in patients with negative MRI. Among 38 men with a negative MRI and a PSAD <0.15, only 3 (8%) had csCaP. In a post-hoc analysis of tumor locations, a discordance of 36% was found between targeted and systematic biopsies, indicating that different tumors were detected by each method (Table 1).
Conclusions: In men with MRI-visible lesions, the combination of systematic and targeted biopsy maximizes csCaP detection (70% vs 47-62% with either method alone). Data from this paired-cohort trial provide high-level evidence that MRI guidance is of value in men undergoing a first prostate biopsy.
Source of Funding: This work was supported in part by the National Cancer Institute (R01CA195505), UCLA CTSI (UL1TR000124), the Jean Perkins Foundation, the Kent Kresa Family Foundation, and the Steven C. Gordon Family Foundation.