Integration and Diagnostic Accuracy of 3T Nonendorectal coil Prostate Magnetic Resonance Imaging in the Context of Active Surveillance.

OBJECTIVE: To evaluate the integration of 3T nonendorectal coil multiparametric prostate magnetic resonance imaging (mpMRI) at 2 high-volume practices that routinely use mpMRI in the setting of active surveillance. MATERIALS AND METHODS: This was an institutional review board-approved, Health Insurance Portability and Accountability Act-compliant, and dual-institution retrospective cohort study. Subjects undergoing 3T mpMRI without endorectal coil at either study institution over a 13-month period (August 1, 2015-August 31, 2016) were selected based on predefined criteria: clinical T1/T2 Gleason 6 prostate cancer, prostate-specific antigen <15 ng/mL, ≥40 years old, mpMRI within 2 years of prostate biopsy, and Prostate Imaging Reporting and Data System (PI-RADS) v2 score assigned. Subjects surveilled for Gleason ≥3 + 4 prostate cancer were excluded. The primary outcome was detection of Gleason ≥3 + 4 prostate cancer on magnetic resonance-ultrasound fusion biopsy, standard biopsy, or prostatectomy within 6 months following mpMRI. Positive predictive values (PPVs) were calculated. RESULTS: A total of 286 subjects (N = 193 from institution 1, N = 93 from institution 2) met the criteria. Most (87% [90 of 104]) with maximum PI-RADS v2 scores of 1-2 did not receive immediate biopsy or treatment and remained on active surveillance. Incidence and PPVs for PI-RADS v2 scores of ≥3 were the following: PI-RADS 3 (n = 57 [20%], PPV 21% [6 of 29]), PI-RADS 4 (n = 96 [34%], PPV 51% [39 of 77]), and PI-RADS 5 (n = 29 [13%], PPV 71% [20 of 28]). No Gleason ≥4 + 3 prostate cancer was identified for PI-RADS v2 scores of 1-3 (0 of 43 with histology). Following mpMRI and subsequent biopsy, 21% (61 of 286) of subjects were removed from active surveillance and underwent definitive therapy. CONCLUSION: The 3T nonendorectal coil mpMRI has been integrated into the care of patients on active surveillance and effectively stratifies risk of Gleason ≥3 + 4 prostate cancer in this population.

Development of a Nationally Representative Coordinated Registry Network for Prostate Ablation Technologies.

PURPOSE: The accumulation of data through a prospective, multicenter coordinated registry network is a practical way to gather real world evidence on the performance of novel prostate ablation technologies. Urological oncologists, targeted biopsy experts, industry representatives and representatives of the FDA (Food and Drug Administration) convened to discuss the role, feasibility and important data elements of a coordinated registry network to assess new and existing prostate ablation technologies. MATERIALS AND METHODS: A multiround Delphi consensus approach was performed which included the opinion of 15 expert urologists, representatives of the FDA and leadership from high intensity focused ultrasound device manufacturers. Stakeholders provided input in 3 consecutive rounds with conference calls following each round to obtain consensus on remaining items. Participants agreed that these elements initially developed for high intensity focused ultrasound are compatible with other prostate ablation technologies. Coordinated registry network elements were reviewed and supplemented with data elements from the FDA common study metrics. RESULTS: The working group reached consensus on capturing specific patient demographics, treatment details, oncologic outcomes, functional outcomes and complications. Validated health related quality of life questionnaires were selected to capture patient reported outcomes, including the IIEF-5 (International Index of Erectile Function-5), the I-PSS (International Prostate Symptom Score), the EPIC-26 (Expanded Prostate Cancer Index Composite-26) and the MSHQ-EjD (Male Sexual Health Questionnaire for Ejaculatory Dysfunction). Group consensus was to obtain followup multiparametric magnetic resonance imaging and prostate biopsy approximately 12 months after ablation with additional imaging or biopsy performed as clinically indicated. CONCLUSIONS: A national prostate ablation coordinated registry network brings forth vital practice pattern and outcomes data for this emerging treatment paradigm in the United States. Our multiple stakeholder consensus identifies critical elements to evaluate new and existing energy modalities and devices.

Standardizing the definition of adverse pathology for lower risk men undergoing radical prostatectomy.

PURPOSE: Numerous definitions of adverse pathology at radical prostatectomy (RP) have been proposed and implemented for both research and clinical care, and there is tremendous variation in the specific criteria used to define adverse pathology in these settings. Given the current landscape in which magnetic resonance imaging criteria and biomarker cutoffs are validated for disparate adverse pathology definitions, we sought to identify which of these is most closely tied to biochemical recurrence (BCR) after RP. MATERIALS AND METHODS: A total of 2,837 patients who underwent RP at a single institution for localized prostate cancer (PCa) were included. We evaluated the following existing definitions of adverse pathology at RP: (1) Gleason score ≥7, (2) primary Gleason pattern ≥4, (3) Gleason score ≥7 or pathologic stage T3-4, (4) pathologic stage T3-4, (5) primary Gleason pattern ≥4 or pathologic stage T3-4. The primary outcome measure was BCR. Multiple statistical techniques were used to assess BCR prediction. RESULTS: Of the 5 definitions assessed, 1 (primary Gleason pattern ≥4 or pathologic stage T3-4, 540 patients [19% of cohort]) consistently outperformed the other definitions across all statistical measures. Additionally, a total of only 13 (6.6%) and 34 (10.3%) men with very-low-risk and low-risk cancer per National Comprehensive Cancer Network guideline, respectively, met this definition of adverse pathology at the time of RP. CONCLUSIONS: Varying definitions of adverse pathology differ in their prognostic performance. The criteria defined by either primary Gleason pattern ≥4 or pT3-4 disease appears to most accurately predict BCR in this subset of patients with lower risk PCa at the time of diagnosis. Additionally, men with very-low-risk or low-risk PCa per National Comprehensive Cancer Network guidelines are relatively unlikely to have adverse pathology at the time of surgical resection. These data may help inform the use of imaging and molecular markers as well as the intensity of surveillance in men with newly diagnosed PCa.