Comparison of Multiparametric MRI-targeted and Systematic Biopsies for Detection of Cribriform and Intraductal Carcinoma Prostate Cancer.

Background Intraductal carcinoma (IDC) and invasive cribriform (Cr) subtypes of prostate cancer (PCa) are an indication of aggressiveness, but the evidence regarding whether MRI can be used to detect Cr/IDC-pattern PCa is contradictory. Purpose To compare the detection of Cr/IDC-pattern PCa at multiparametric MRI (mpMRI)-targeted biopsy versus systematic biopsy in biopsy-naive men at risk for PCa. Materials and Methods This study was a secondary analysis of a prospective randomized controlled trial that recruited participants with a clinical suspicion of PCa between April 2017 and November 2019 at five centers. Participants were randomized 1:1 to either the MRI arm or the systematic biopsy arm. Targeted biopsy was performed in participants with a Prostate Imaging Reporting and Data System score of at least 3. MRI features were recorded, and biopsy slides and prostatectomy specimens were reviewed for the presence or absence of Cr/IDC histologic patterns. Comparison of Cr/IDC patterns was performed using generalized linear mixed modeling. Results A total of 453 participants were enrolled, with 226 in the systematic biopsy arm (median age, 65 years [IQR, 59-70 years]; 196 biopsies available for assessment) and 227 in the mpMRI-targeted biopsy arm (median age, 67 years [IQR, 60-72 years]; 132 biopsies available for assessment). Identification of Cr/IDC PCa was lower in the systematic biopsy arm compared with the mpMRI arm (31 of 196 biopsies [16%] vs 33 of 132 biopsies [25%]; P = .01). No evidence of a difference in mean cancer core length (CCL) (11.3 mm ± 4.4 vs 9.7 mm ± 4.5; P = .09), apparent diffusion coefficient (685 µm2/sec ± 178 vs 746 µm2/sec ± 245; P = .52), or dynamic contrast-enhanced positivity (27 [82%] vs 37 [90%]; P = .33) for clinically significant PCa (csPCa) was observed between participants with or without Cr/IDC disease in the MRI arm. Cr/IDC-positive histologic patterns overall had a higher mean CCL compared with Cr/IDC-negative csPCa (11.1 mm ± 4.4 vs 9.2 mm ± 4.1; P = .009). Conclusion MRI-targeted biopsy showed increased detection of Cr/IDC histologic patterns compared with systematic biopsy. Clinical trial registration no. NCT02936258 © RSNA, 2024 Supplemental material is available for this article. See also the editorial by Scialpi and Martorana in this issue.

MRI-guided Focused Ultrasound Focal Therapy for Intermediate-Risk Prostate Cancer: Final Results from a 2-year Phase II Clinical Trial.

Background MRI-guided focal therapy (FT) allows for accurate targeting of localized clinically significant prostate cancer (csPCa) while preserving healthy prostate tissue, but the long-term outcomes of this approach require more study. Purpose To assess the 2-year oncological and functional outcomes of men with intermediate-risk prostate cancer (PCa) treated with targeted FT. Materials and Methods In this single-center prospective phase II trial, men with localized unifocal intermediate-risk PCa underwent transrectal MRI-guided focused ultrasound between July 2016 and July 2019. Planned ablation volumes included 10-mm margins when possible. Data regarding adverse events were collected and quality-of-life questionnaires were completed by participants at 6 weeks and at 5, 12, 18, and 24 months after treatment. Multiparametric MRI and targeted and systematic biopsies were performed at 24 months. Ablation volumes were determined by manual contouring of nonperfused volumes on immediate contrast-enhanced images. Generalized estimating equations were used to model trends in quality-of-life measures. Results Treatment was successfully completed in the 44 participants (median age, 67 years; IQR, 62-70 years; 36 patients with grade group [GG] 2; eight patients with GG 3). No major adverse events from treatment were recorded. One participant refused biopsy at 24 months. After 2 years, 39 of 43 participants (91%) had no csPCa at the treatment site and 36 of 43 (84%) had no cancer in the entire gland. No changes in International Index of Erectile Function-15 score or International Prostate Symptom Score were observed during 2-year follow-up (P = .73 and .39, respectively). Conclusion The majority of men treated with MRI-guided focused ultrasound for intermediate risk PCa had negative results for csPCa at biopsy 2 years after treatment. Additionally, there was no significant decline in quality of life per the validated questionnaires. Clinical trial registration no. NCT02968784 © RSNA, 2024 Supplemental material is available for this article. See also the editorial by Woodrum in this issue.

Is MRI ready to replace biopsy during active surveillance?

Active surveillance (AS) is a conservative management option recommended for patients diagnosed with low-risk prostate cancer (PCa) and selected cases with intermediate-risk PCa. The adoption of prostate MRI in the primary diagnostic setting has sparked interest in its application during AS. This review aims to examine the role and performance of multiparametric MRI (mpMRI) across the entire AS pathway, from initial stratification to follow-up, also relative to the utilization of the Prostate Cancer Radiological Estimation of Change in Sequential Evaluation (PRECISE) criteria. Given the high negative predictive value of mpMRI in detecting clinically significant PCa (csPCa), robust evidence supports its use in patient selection and risk stratification at the time of diagnosis or confirmatory biopsy. However, conflicting results have been observed when using MRI in evaluating disease progression during follow-up. Key areas requiring clarification include addressing the clinical significance of MRI-negative csPCa, optimizing MRI quality, determining the role of biparametric MRI (bpMRI) or mpMRI protocols, and integrating artificial intelligence (AI) for improved performance. CLINICAL RELEVANCE STATEMENT: MRI plays an essential role in the selection, stratification, and follow up of patients in active surveillance (AS) for prostate cancer. However, owing to existing limitations, it cannot fully replace biopsies in the context of AS. KEY POINTS: Multiparametric MRI (mpMRI) has become a crucial tool in active surveillance (AS) for prostate cancer (PCa). Conflicting results have been observed regarding multiparametric MRI efficacy in assessing disease progression. Standardizing MRI-guided protocols will be critical in addressing current limitations in active surveillance for prostate cancer.

New Prostate MRI Scoring Systems (PI-QUAL, PRECISE, PI-RR, and PI-FAB): AJR Expert Panel Narrative Review.

Multiparametric MRI (mpMRI), interpreted using PI-RADS, improves the initial detection of clinically significant prostate cancer (PCa). Prostate MR image quality has increasingly recognized relevance to the use of mpMRI for PCa diagnosis. Additionally, mpMRI is increasingly used in scenarios beyond initial detection, including active surveillance and assessment for local recurrence after prostatectomy, radiation therapy, or focal therapy. Acknowledging these evolving demands, specialized prostate MRI scoring systems beyond PI-RADS have emerged, to address distinct scenarios and unmet needs. Examples include Prostate Imaging Quality (PI-QUAL) for assessment of image quality of mpMRI, Prostate Cancer Radiologic Estimation of Change in Sequential Evaluation (PRECISE) recommendations for evaluation of serial mpMRI examinations during active surveillance, Prostate Imaging for Recurrence Reporting System (PI-RR) for assessment for local recurrence after prostatectomy or radiation therapy, and Prostate Imaging after Focal Ablation (PI-FAB) for assessment for local recurrence after focal therapy. These systems' development and early uptake signal a compelling shift towards prostate MRI standardization in different scenarios, and ongoing research will help refine their roles in practice. This AJR Expert Panel Narrative Review critically examines these new prostate MRI scoring systems (PI-QUAL, PRECISE, PI-RR, and PI-FAB), analyzing the available evidence, delineating current limitations, and proposing solutions for improvement.

MRI-guided Minimally Invasive Focal Therapies for Prostate Cancer.

Two cases involving patients diagnosed with localized prostate cancer and treated with MRI-guided focal therapies are presented. Patient selection procedures, techniques, outcomes, challenges, and future directions of MRI-guided focal therapies, as well as their role in the treatment of low- to intermediate-risk localized prostate cancer, are summarized.

The role of [18F]-DCFPyL PET/MRI radiomics for pathological grade group prediction in prostate cancer.

PURPOSE: To evaluate the diagnostic accuracy of [18F]-DCFPyL PET/MRI radiomics for the prediction of pathological grade group in prostate cancer (PCa) in therapy-naïve patients. METHODS: Patients with confirmed or suspected PCa, who underwent [18F]-DCFPyL PET/MRI (n = 105), were included in this retrospective analysis of two prospective clinical trials. Radiomic features were extracted from the segmented volumes following the image biomarker standardization initiative (IBSI) guidelines. Histopathology obtained from systematic and targeted biopsies of the PET/MRI-detected lesions was the reference standard. Histopathology patterns were dichotomized as ISUP GG 1-2 vs. ISUP GG ≥ 3 categories. Different single-modality models were defined for feature extraction, including PET- and MRI-derived radiomic features. The clinical model included age, PSA, and lesions' PROMISE classification. Single models, as well as different combinations of them, were generated to calculate their performances. A cross-validation approach was used to evaluate the internal validity of the models. RESULTS: All radiomic models outperformed the clinical models. The best model for grade group prediction was the combination of PET + ADC + T2w radiomic features, showing sensitivity, specificity, accuracy, and AUC of 0.85, 0.83, 0.84, and 0.85, respectively. The MRI-derived (ADC + T2w) features showed sensitivity, specificity, accuracy, and AUC of 0.88, 0.78, 0.83, and 0.84, respectively. PET-derived features showed 0.83, 0.68, 0.76, and 0.79, respectively. The baseline clinical model showed 0.73, 0.44, 0.60, and 0.58, respectively. The addition of the clinical model to the best radiomic model did not improve the diagnostic performance. The performances of MRI and PET/MRI radiomic models as per the cross-validation scheme yielded an accuracy of 0.80 (AUC = 0.79), whereas clinical models presented an accuracy of 0.60 (AUC = 0.60). CONCLUSION: The combined [18F]-DCFPyL PET/MRI radiomic model was the best-performing model and outperformed the clinical model for pathological grade group prediction, indicating a complementary value of the hybrid PET/MRI model for non-invasive risk stratification of PCa. Further prospective studies are required to confirm the reproducibility and clinical utility of this approach.

PI-RR: The Prostate Imaging for Recurrence Reporting System for MRI Assessment of Local Prostate Cancer Recurrence After Radiation Therapy or Radical Prostatectomy-A Review.

The purpose of this article is to review clinical application of the Prostate Imaging for Recurrence Reporting (PI-RR) system. This system, released in 2021, represents international consensus-based guidelines for the acquisition, interpretation, and reporting of multiparametric MRI performed to detect locally recurrent prostate cancer after radiation therapy or radical prostatectomy. The system reduces variability through use of a standardized and structured reporting approach whereby the overall level of suspicion of recurrence is classified on a 5-point scale. The overall suspicion score is derived from 5-point scales for assessing DWI and dynamic contrast-enhanced (DCE) imaging. Separate scales for both DWI and DCE imaging are provided for evaluation after radiation therapy and after radical prostatectomy. These scales account for the relation between detected abnormalities and the location of the primary tumor on pretreatment imaging. T2-weighted imaging is also assessed on a 5-point scale and is useful for anatomic imaging but does not influence the overall score. Initial retrospective studies have shown promising results with respect to the reproducibility and accuracy of PI-RR in detecting locally recurrent tumor.

Comparison of Micro-US and Multiparametric MRI for Prostate Cancer Detection in Biopsy-Naive Men.

Background Multiparametric MRI has led to increased detection of clinically significant prostate cancer (csPCa). Micro-US is being investigated for csPCa detection. Purpose To compare multiparametric MRI and micro-US in detecting csPCa (grade group ≥2) and to determine the proportion of MRI nodules visible at micro-US for real-time targeted biopsy. Materials and methods This prospective, single-center trial enrolled biopsy-naive men with suspected prostate cancer (PCa) between May 2019 and September 2020. All patients underwent multiparametric MRI followed by micro-US; findings at both were interpreted in a blinded fashion, followed by targeted biopsy and nontargeted systematic biopsy using micro-US. Proportions were compared using the exact McNemar test. The differences in proportions were calculated. Results Ninety-four men (median age, 61 years; IQR, 57-68 years) were included. MRI- and micro-US-targeted biopsy depicted csPCa in 37 (39%) and 33 (35%) of the 94 men, respectively (P = .22); clinically insignificant PCa in 14 (15%) and 15 (16%) (P > .99); and cribriform and/or intraductal PCa in 14 (15%) and 13 (14%) (P > .99). The MRI- plus micro-US-targeted biopsy pathway depicted csPCa in 38 of the 94 (40%) men. The addition of nontargeted systematic biopsy to MRI- plus micro-US-targeted biopsy did not enable identification of any additional men with csPCa but did help identify nine additional men with clinically insignificant PCa (P = .04). Biopsy was avoided in 32 of the 94 men (34%) with MRI and nine of the 94 men (10%) with micro-US (P < .001). Among 93 MRI targets, 62 (67%) were prospectively visible at micro-US. Conclusion MRI and micro-US showed similar rates of prostate cancer detection, but more biopsies were avoided with the MRI pathway than with micro-US, with no benefit of adding nontargeted systematic biopsy to the MRI- plus micro-US-targeted biopsy pathway. Most MRI lesions were prospectively visible at micro-US, allowing real-time targeted biopsy. ClinicalTrials.gov registration no.: NCT03938376 © RSNA, 2022 Online supplemental material is available for this article.

Prostate biopsy in the era of MRI-targeting: towards a judicious use of additional systematic biopsy.

OBJECTIVES: We aimed to develop and compare strategies that help optimize current prostate biopsy practice by identifying patients who may forgo concurrent systematic biopsy (SBx) in favor of MRI-targeted (TBx) alone. METHODS: Retrospective study on 745 patients who underwent combined MRI-TBx plus SBx. Primary outcome was the upgrade to clinically significant prostate cancer (csPCa; grade group ≥ 2) on SBx versus MRI-TBx. Variables (age, previous biopsy status, Prostate Imaging Reporting and Data System (PI-RADS) score, index lesion size/location, number of lesions, PSA, PSA density, prostate volume) associated with the primary outcome were identified by logistic regression and used for biopsy strategies. Clinical utility was assessed by decision curve analysis (DCA). RESULTS: SBx detected 47 (6%) additional men with csPCa. The risk of detecting csPCa uniquely on SBx was significantly lower in men with PI-RADS 5 (versus PI-RADS 3: OR 0.30, p = 0.03; versus PI-RADS 4: OR 0.33, p = 0.01), and previous negative biopsy (versus previous positive biopsy: OR 0.40, p = 0.007), and increased with age (per 10 years: OR 1.64, p = 0.016). No significant association was observed for other variables. DCA identified the following strategies as most useful: (a) avoid SBx in men with PI-RADS 5 and (b) additionally in those with previous negative biopsy, resulting in avoiding SBx in 201 (27%) and 429 (58%), while missing csPCa in 5 (1%) and 15 (2%) patients, respectively. CONCLUSION: Not all men benefit equally from the combination of SBx and MRI-TBx. SBx avoidance in men with PI-RADS 5 and/or previous negative biopsy may reduce the risk of excess biopsies with a low risk of missing csPCa. KEY POINTS: • In men undergoing MRI-targeted biopsy, the risk of detecting clinically significant prostate cancer (csPCa) only on additional systematic biopsy (SBx) decreased in men with PI-RADS 5, previous negative biopsy, and younger age. • Using these variables may help select men who could avoid the risk of excess SBx. • If missing csPCa in 5% was acceptable, forgoing SBx in men with PI-RADS 5 and/or previous negative biopsy enabled the highest net reduction in SBx.

Exploring the value of using patient-oriented MRI reports in clinical practice - a pilot study.

PURPOSE: Standard radiology reports (SRR) are designed to communicate information between doctors. With many patients having instantaneous access to SRRs on patient portals, interpretation without guidance from doctors can cause anxiety and panic. In this pilot study, we designed a patient-centred prostate MRI template report (PACERR) to address some of these challenges and tested whether PACERRs improve patient knowledge and experience. MATERIALS AND METHODS: Patients booked for clinical prostate MRI were randomly assigned to SRR or SRR + PACERR. Questionnaires included multiple-choice that targeted 4 domains (understanding, usefulness, next steps, emotional experience) hypothesized to improve with patient-centred reports and short answer questions, testing knowledge regarding MRI results. Clinical encounters were observed and recorded to explore whether adding PACERR improved communication. Likert scaled-responses and short-answer questions were compared using Mann-Whitney U test and Kruskal-Wallis test. RESULTS: Of the 40 participants, the majority were MRI naïve (70%). Patients receiving a PACERR had higher scores in the categories of patient understanding (mean: 4.17 vs. 3.39, p=0.006), usefulness (mean: 4.58 vs. 3.07, p<0.001), and identifying next steps (mean: 1.89 vs. 3.03, p=0.003) but not emotional experience (mean: 4.18 vs. 3.79, p=0.22). PACERR participants found the layout and design more patient friendly (mean: 4.47 vs. 2.61, p<0.001) and easier to understand (mean: 4.37 vs. 2.38, p<0.001). In the knowledge section, overall, the PACERR arm scored better (87% vs. 56%, p=0.004). CONCLUSION: With the addition of prostate MRI PACERR, participants had better understanding of their results and felt more prepared to involve themselves in discussions with their doctor.

Avoiding Unnecessary Biopsy: MRI-based Risk Models versus a PI-RADS and PSA Density Strategy for Clinically Significant Prostate Cancer.

Background In validation studies, risk models for clinically significant prostate cancer (csPCa; Gleason score ≥3+4) combining multiparametric MRI and clinical factors have demonstrated poor calibration (over- and underprediction) and limited use in avoiding unnecessary prostate biopsies. Purpose MRI-based risk models following local recalibration were compared with a strategy that combined Prostate Imaging Data and Reporting System (PI-RADS; version 2) and prostate-specific antigen density (PSAd) to assess the potential reduction of unnecessary prostate biopsies. Materials and Methods This retrospective study included 385 patients without prostate cancer diagnosis who underwent multipara-metric MRI (PI-RADS category ≥3) and MRI-targeted biopsy between 2015 and 2019. Recalibration and selection of the best-performing MRI model (MRI-European Randomized Study of Screening for Prostate Cancer [ERSPC], van Leeuwen, Radtke, and Mehralivand models) were undertaken in cohort C1 (n = 242; 2015-2017). The impact on biopsy decisions was compared with an alternative strategy (no biopsy for PI-RADS category 3 plus PSAd < 0.1 ng/mL per milliliter) in cohort C2 (n = 143; 2018-2019). Discrimination, calibration, and clinical utility were assessed by using the area under the receiver operating characteristic curve (AUC), calibration plots, and decision curve analysis, respectively. Results The prevalence of csPCa was 38% (93 of 242 patients) and 45% (64 of 143 patients) in cohorts C1 and C2, respectively. Decision curve analysis demonstrated the highest net benefit for the van Leeuwen and Mehralivand models in C1. Used for biopsy decisions in C2, van Leeuwen (AUC, 0.84; 95% CI: 0.77, 0.9) and Mehralivand (AUC, 0.79; 95% CI: 0.72, 0.86) enabled no net benefit at a risk threshold of 10%. Up to a risk threshold of 15%, net benefit remained inferior to the PI-RADS plus PSAd strategy, which avoided biopsy in 63 per 1000 men, without missing csPCa. Without prior recalibration in C1, three of four models (MRIERSPC, Radtke, Mehralivand) were poorly calibrated and not clinically useful in C2. Conclusion The number of unnecessary prostate biopsies in men with positive MRI may be safely reduced by using a prostate-specific antigen density-based strategy. In a risk-averse scenario, this strategy enabled better biopsy decisions compared with MRI-based risk models. ©RSNA, 2021 Online supplemental material is available for this article.

MRI-guided Focused Ultrasound Ablation for Localized Intermediate-Risk Prostate Cancer: Early Results of a Phase II Trial.

Background To reduce adverse effects of whole-gland therapy, participants with localized clinically significant prostate cancer can undergo MRI-guided focal therapy. Purpose To explore safety and early oncologic and functional outcomes of targeted focal high-intensity focused ultrasound performed under MRI-guided focused ultrasound for intermediate-risk clinically significant prostate cancer. Materials and Methods In this prospective phase II trial, between February 2016 and July 2019, men with unifocal clinically significant prostate cancer visible at MRI were treated with transrectal MRI-guided focused ultrasound. The primary end point was the 5-month biopsy (last recorded in December 2019) with continuation to the 24-month follow-up projected to December 2021. Real-time ablation monitoring was performed with MR thermography. Nonperfused volume was measured at treatment completion. Periprocedural complications were recorded. Follow-up included International Prostate Symptom Score (IPSS) and International Index of Erectile Function-15 (IIEF-15) score at 6 weeks and 5 months, and multiparametric MRI and targeted biopsy of the treated area at 5 months. The generalized estimating equation model was used for statistical analysis, and the Holm method was used to adjust P value. Results Treatment was successfully completed in all 44 men, 36 with grade group (GG) 2 and eight with GG 3 disease (median age, 67 years; interquartile range [IQR], 62-70 years). No major treatment-related adverse events occurred. Forty-one of 44 participants (93%; 95% CI: 82, 98) were free of clinically significant prostate cancer (≥6 mm GG 1 disease or any volume ≥GG 2 disease) at the treatment site at 5-month biopsy (median, seven cores). Median IIEF-15 and IPSS scores were similar at baseline and at 5 months (IIEF-15 score at baseline, 61 [IQR, 34-67] and at 5 months, 53 [IQR, 24-65.5], P = .18; IPSS score at baseline, 3.5 [IQR, 1.8-7] and at 5 months, 6 [IQR, 2-7.3], P = .43). Larger ablations (≥15 cm3) compared with smaller ones were associated with a decline in IIEF-15 scores at 6 weeks (adjusted P < .01) and at 5 months (adjusted P = .07). Conclusion Targeted focal therapy of intermediate-risk prostate cancer performed with MRI-guided focused ultrasound ablation was safe and had encouraging early oncologic and functional outcomes. © RSNA, 2021 Online supplemental material is available for this article See also the editorial by Tempany-Afdhal in this issue.

Detection of clinically significant prostate cancer with 18F-DCFPyL PET/multiparametric MR.

PURPOSE: To assess whether 18F-DCFPyL PET/multiparametric (mp)MR contributes to the diagnosis of clinically significant (cs) prostate cancer (PCa) compared to mpMR in patients with suspicion of PCa, or patients being considered for focal ablative therapies (FT). PATIENTS AND METHODS: This ethics review board-approved, prospective study included 55 men with suspicion of PCa and negative systematic biopsies or clinically discordant low-risk PCa (n = 21) or those being considered for FT (n = 34) who received 18F-DCFPyL PET/mpMR. Each modality, PET, mpMR, and PET/MR (using the PROMISE classification), was assessed independently. All suspicious lesions underwent PET/MR-ultrasound fusion biopsies. RESULTS: There were 45/55 patients (81.8%) that had histologically proven PCa and 41/55 (74.5%) were diagnosed with csPCa. Overall, 61/114 lesions (53.5%) identified on any modality were malignant; 49/61 lesions (80.3%) were csPCa. On lesion-level analysis, for detection of csPCa, the sensitivity of PET was higher than that of mpMR and PET/MR (86% vs 67% and 69% [p = 0.027 and 0.041, respectively]), but at a lower specificity (32% vs 85% and 86%, respectively [p < 0.001]). The performance of MR and PET/MR was comparable. For identification of csPCa in PI-RADS ≥ 3 lesions, the AUC (95% CI) for PET, mpMR, and PET/MR was 0.75 (0.65-0.86), 0.69 (0.56-0.82), and 0.78 (0.67-0.89), respectively. The AUC for PET/MR was significantly larger than that of mpMR (p = 0.04). CONCLUSION: PSMA PET detects more csPCa than mpMR, but at low specificity. The performance PET/MR is better than mpMR for detection of csPCa in PI-RADS ≥ 3 lesions. CLINICAL REGISTRATION: NCT03149861.

Research biopsies in patients with gynecologic cancers: patient-reported outcomes, perceptions, and preferences.

BACKGROUND: Despite the growing integration of mandatory biopsies for correlative endpoints within oncology clinical trials, there are sparse data on patient-reported outcomes, perceptions, and preferences. OBJECTIVE: This study aimed to prospectively assess the impact of research biopsies on the quality of life in patients with gynecologic cancer, evaluate patient-reported outcomes, and determine factors associated with patients' willingness to undergo sequential biopsies. STUDY DESIGN: We conducted a prospective study in patients with gynecologic malignancies undergoing research biopsies between 2015 and 2019 at Princess Margaret Cancer Centre (ClinicalTrials.gov Identifier: NCT02334761). Here, we report the results of the paper-based surveys performed before and 1 week after biopsy. Although the questionnaires each assessed the impact of anxiety using a modified version of the Hospital Anxiety and Depression Scale, the postbiopsy questionnaire specifically assessed the likelihood of future biopsies, postbiopsy symptoms, complications, and perceptions. RESULTS: A total of 129 patients were enrolled, of which 91 (70.5%) completed at least 1 questionnaire. These patients had either ovarian (89%; 81 of 91) or endometrial cancer (11%; 10 of 91). Of all biopsies taken, 75% were from the abdomen or pelvis (67 of 89). There was 1 clinician-reported complication, a perihepatic hematoma (1%). Pain during the biopsy and physical discomfort were experienced by 60.3% (41 of 68) and 61.8% (42 of 68), respectively. Embarrassment and loss of dignity were experienced by 13.2% (9 of 68) and 11.8% (8 of 68), respectively. Although the mean Hospital Anxiety and Depression Scale score was in the normal range before and after biopsy, there was a significant decline in the total score after the biopsy (prebiopsy, 5.3 [standard deviation, 4.7] vs postbiopsy, 3.7 [standard deviation, 4.5]; P=.005); 84% of subjects (58 of 69) stated that they would definitely or likely consent to another biopsy. There was no impact on patients' willingness for future biopsies based on Eastern Cooperative Oncology Group status, biopsy site, age, number of cores, and pain during the biopsy; however, subjects who reported feeling physically uncomfortable (odds ratio, 0.14; P=.005), embarrassed (odds ratio, 0.03; P=.004) or experienced loss of dignity (odds ratio, 0.05; P=.01) during the biopsy and those who experienced flu-like symptoms (odds ratio, 0.2; P=.018) or felt feverish (odds ratio, 0.2; P=.035) 1 week after biopsy, were less likely to undergo a sequential biopsy. Similarly, those with higher Hospital Anxiety and Depression Scale scores before biopsy (odds ratio, 0.83; P=.008) and after biopsy (odds ratio, 0.8; P=.003) were less likely to consent for another biopsy. CONCLUSION: Research biopsies were generally well accepted. Most patients (83%) were willing to undergo serial biopsies if necessary. Addressing the potentially modifiable psychosocial aspects of the procedure may improve the experience with research biopsies for patients with gynecologic cancers.

Advanced ultrasound in the diagnosis of prostate cancer.

The diagnosis of prostate cancer (PCa) can be challenging due to the limited performance of current diagnostic tests, including PSA, digital rectal examination and transrectal conventional US. Multiparametric MRI has improved PCa diagnosis and is recommended prior to biopsy; however, mp-MRI does miss a substantial number of PCa. Advanced US modalities include transrectal prostate elastography and contrast-enhanced US, as well as improved B-mode, micro-US and micro-Doppler techniques. These techniques can be combined to define a novel US approach, multiparametric US (mp-US). Mp-US improves PCa diagnosis but is not sufficiently accurate to obviate the utility of mp-MRI. Mp-US using advanced techniques and mp-MRI provide complementary information which will become even more important in the era of focal therapy, where precise identification of PCa location is needed.

MRI Targeted Prostate Biopsy Techniques: AJR Expert Panel Narrative Review.

Prostate cancer is the second most common malignancy in men worldwide. Systematic transrectal prostate biopsy is commonly used to obtain tissue to establish the diagnosis. In recent years, however, more clinically significant cancer and less clinically insignificant cancer have been detected with MRI targeted biopsy (on the basis of an MRI examination performed before consideration of biopsy) than with systematic biopsy. This approach of performing MRI before biopsy has become, or is becoming, a standard of practice in centers throughout the world. This growing use of an MRI-directed pathway is leading to performance of a larger volume of MRI targeted prostate biopsies. The three common MRI targeted biopsy techniques are cognitive biopsy, MRI-ultrasound software fusion biopsy, and MRI in-bore guided biopsy. These techniques for using MRI information at biopsy can be performed via a transrectal or transperineal approach. The purpose of this review is to describe the three MRI targeted biopsy techniques and their advantages and shortcomings. Comparisons among the techniques are summarized on the basis of the available evidence. Studies to date have had heterogeneous results, and the preferred technique remains debated.

Quantitative Prostate MRI Analysis Following Fluvastatin Therapy for Localized Prostate Cancer - A Pilot Study.

PURPOSE: To assess the role of multi-parametric MRI (mpMRI) in assessment of tumor response to fluvastatin administered prior to radical prostatectomy. METHODS: Men with MRI-visible, clinically significant prostate cancer and due to be treated with radical prostatectomy were prospectively enrolled. mpMRI was performed at baseline and following 6-7 week of neoadjuvant oral statin therapy (40 mg fluvastatin, twice daily), prior to prostatectomy. MRI assessment included tumor size, T2 relaxation time, ADC value, K-trans (volume transfer constant), Kep (reflux constant), and Ve (fractional volume) parameters at the 2 time points. Initial prostate needle biopsy cores, prior to starting oral statin therapy, corresponding to site of tumor on radical prostatectomy specimens were selected for analysis. The effect of fluvastatin on tumor proliferation (marker Ki67) and on tumor cell apoptosis (marker cleaved Caspase-3, CC3) were analyzed and correlated with MRI findings. RESULTS: Nine men with paired MRI studies were included in the study. Binary histopathological data was available for 6 of the participants. No significant change in tumor size (P = 0.898), T2 relaxation time (P = 0.213), ADC value (P = 0.455), K-trans (P = 0.613), Kep (P = 0.547) or Ve (P = 0.883) between the time of biopsy and prostatectomy were observed. No significant change in tumor proliferation (%Ki67-positive cells, P = 0.766) was observed by immunohistochemistry analysis. However, there was a significant increase in tumor cell apoptosis (%CC3-positive cells, P = 0.047). CONCLUSION: mpMRI techniques may not be sufficiently sensitive to detect the types (or magnitude) of tumor cell changes observed following 6-7 weeks of fluvastatin therapy for prostate cancer.

Variability of the Positive Predictive Value of PI-RADS for Prostate MRI across 26 Centers: Experience of the Society of Abdominal Radiology Prostate Cancer Disease-focused Panel.

Background Prostate MRI is used widely in clinical care for guiding tissue sampling, active surveillance, and staging. The Prostate Imaging Reporting and Data System (PI-RADS) helps provide a standardized probabilistic approach for identifying clinically significant prostate cancer. Despite widespread use, the variability in performance of prostate MRI across practices remains unknown. Purpose To estimate the positive predictive value (PPV) of PI-RADS for the detection of high-grade prostate cancer across imaging centers. Materials and Methods This retrospective cross-sectional study was compliant with the HIPAA. Twenty-six centers with members in the Society of Abdominal Radiology Prostate Cancer Disease-focused Panel submitted data from men with suspected or biopsy-proven untreated prostate cancer. MRI scans were obtained between January 2015 and April 2018. This was followed with targeted biopsy. Only men with at least one MRI lesion assigned a PI-RADS score of 2-5 were included. Outcome was prostate cancer with Gleason score (GS) greater than or equal to 3+4 (International Society of Urological Pathology grade group ≥2). A mixed-model logistic regression with institution and individuals as random effects was used to estimate overall PPVs. The variability of observed PPV of PI-RADS across imaging centers was described by using the median and interquartile range. Results The authors evaluated 3449 men (mean age, 65 years ± 8 [standard deviation]) with 5082 lesions. Biopsy results showed 1698 cancers with GS greater than or equal to 3+4 (International Society of Urological Pathology grade group ≥2) in 2082 men. Across all centers, the estimated PPV was 35% (95% confidence interval [CI]: 27%, 43%) for a PI-RADS score greater than or equal to 3 and 49% (95% CI: 40%, 58%) for a PI-RADS score greater than or equal to 4. The interquartile ranges of PPV at these same PI-RADS score thresholds were 27%-44% and 27%-48%, respectively. Conclusion The positive predictive value of the Prostate Imaging and Reporting Data System was low and varied widely across centers. © RSNA, 2020 Online supplemental material is available for this article. See also the editorial by Milot in this issue.

Does the Visibility of Grade Group 1 Prostate Cancer on Baseline Multiparametric Magnetic Resonance Imaging Impact Clinical Outcomes?

PURPOSE: We assessed whether the visibility of Grade Group (GG) 1 prostate cancer on baseline multiparametric magnetic resonance imaging affects clinical outcomes. MATERIALS AND METHODS: We evaluated 454 men who underwent multiparametric magnetic resonance imaging between 2006 and 2018 with maximum GG1 prostate cancer inclusive of magnetic resonance imaging targeted biopsy. Multiparametric magnetic resonance imaging was graded as negative, equivocal or positive. Assessed outcomes were treatment-free survival, biopsy upgrade-free survival and unfavorable disease at radical prostatectomy (pT 3 or greater and/or GG3 or greater). Kaplan-Meier and multivariable Cox proportional hazard analyses were used to estimate the impact of multiparametric magnetic resonance imaging and clinicopathological variables (age, year, prostate specific antigen density and measures of tumor volume on biopsy) on outcomes. RESULTS: During followup (median 45.2 months) 61 men had disease upgraded on followup biopsy and 139 underwent definitive treatment. In men with negative, equivocal and positive baseline multiparametric magnetic resonance imaging at 5 years, treatment-free survival was 79%, 73% and 49% (p <0.0001), treatment-free survival was 89%, 82% and 70% (p=0.002), and survival without unfavorable disease at radical prostatectomy was 98%, 98% and 86% (p=0.007), respectively. At multivariable analysis positive (HR 1.93, 95% CI 1.21-3.09, p=0.006) and equivocal multiparametric magnetic resonance imaging (HR 2.02, 95% CI 1.11-3.68, p=0.02) were associated with shorter treatment-free survival, and positive multiparametric magnetic resonance imaging was a significant prognostic factor for upgrade-free survival (HR 2.03, 95% CI 1.06-3.86, p=0.03) and unfavorable disease at radical prostatectomy (HR 4.45, 95% CI 1.39-18.17, p=0.01). CONCLUSIONS: Men with positive multiparametric magnetic resonance imaging and GG1 prostate cancer on magnetic resonance imaging targeted biopsy are at increased risk for intervention, upgrading and unfavorable disease at radical prostatectomy compared to those with multiparametric magnetic resonance imaging invisible GG1 prostate cancer.

Negative Predictive Value of Prostate Multiparametric Magnetic Resonance Imaging among Men with Negative Prostate Biopsy and Elevated Prostate Specific Antigen: A Clinical Outcome Retrospective Cohort Study.

PURPOSE: We estimated the negative predictive value of prostate multiparametric magnetic resonance imaging to detect clinically significant (Gleason 7 or greater) prostate cancer at long-term followup (median 6.7 years, range 2.6 to 10.7), in men with negative biopsy findings before magnetic resonance imaging. We also assessed the diagnostic performance of multiparametric magnetic resonance imaging to detect clinically significant prostate cancer during this time. MATERIALS AND METHODS: Following Institutional Research Ethics Board approval we retrospectively identified men who underwent prostate multiparametric magnetic resonance imaging after biopsy between 2004 and 2009 using a cancer registry database and magnetic resonance imaging reports. Multiparametric magnetic resonance imaging sequences comprised T2-weighted and dynamic contrast-enhanced series from 2004 to 2005 with diffusion-weighted imaging from 2006 and thereafter. Clinical outcomes were assessed up to July 2015 by reviewing subsequent pathology results, prostate specific antigen levels and electronic patient records. The primary outcome was clinically significant prostate cancer diagnosis during followup. We also estimated the sensitivity, specificity, and positive and negative predictive values of all prostate multiparametric magnetic resonance imaging during this period. RESULTS: A total of 502 multiparametric magnetic resonance imaging scans with a prior biopsy were included in study. Of these scans 121 were done in men with a prior systematic biopsy negative for cancer. In these men median prostate specific antigen was 9.5 ng/dl and median age was 60 years. At a median followup of 6.7 years (95% CI 2.6 to 10.7) 70 of 73 (96%) men with negative multiparametric magnetic resonance imaging findings remained free of clinically significant prostate cancer. In this period the overall negative and positive predictive values of multiparametric magnetic resonance imaging were 86% (range 80% to 91%) and 54% (range 52% to 57%), respectively, in the entire cohort regardless of biopsy status before magnetic resonance imaging. CONCLUSIONS: Prostate multiparametric magnetic resonance imaging has high clinical negative predictive value. In men with a negative biopsy before magnetic resonance imaging and negative magnetic resonance imaging findings the risk of clinically significant prostate cancer was extremely low at a median of 6.7 years.