Therapy decisions after diagnosis of prostate cancer in men with negative prostate MRI.

BACKGROUND: To investigate the clinical implications of magnetic resonance imaging (MRI) negative prostate cancer (PCa) in a cohort of men undergoing transperineal prostate biopsy. METHODS: We included all men without prior diagnosis of PCa undergoing transperineal template saturation ± fusion-guided targeted biopsy of the prostate between November 2014 and March 2018. Before biopsy, all patients underwent MRI and biopsies were performed irrespective of imaging results. Baseline characteristics, imaging, biopsy results, and follow-up information were retrieved from the patient charts. Patients were classified as either MRI negative (Prostate Imaging Reporting and Data System [PIRADS] ≤ 2) or positive (PIRADS ≥ 3). ISUP grade group 1 was defined as clinically nonsignificant (nsPCa) and ≥2 as clinically significant PCa (csPCa). Primary outcome was the individual therapeutic decision after diagnosis of PCa stratified according to MRI visibility. Secondary outcomes were the sensitivity and specificity of MRI, and the urooncological outcomes after radical prostatectomy (RP). RESULTS: From 515 patients undergoing prostate biopsy, 171 (33.2%) patients had a negative and 344 (66.8%) a positive MRI. Pathology review stratified for MRI negative and positive cases revealed nsPCa in 27 (15.8%) and 32 (9.3%) and csPCa in 26 (15.2%) and 194 (56.4%) of the patients, respectively. The rate of active treatment in the MRI negative was lower compared with the MRI positive cohort (12.3% vs. 53.2%; odd ratio [OR] = 0.12; p < 0.001). While men with negative MRI were more likely to undergo active surveillance (AS) than MRI positive patients (18.1% vs. 10.8%; OR = 1.84; p = 0.027), they rarely underwent RP (6.4% vs. 40.7%, OR = 0.10; p < 0.001). Logistic regression revealed that a negative MRI was independently protective for active treatment (OR = 0.32, p = 0.014). The specificity, sensitivity, negative, and positive predictive value of MRI for detection of csPCa were 49.2%, 88.2%, 56.4%, and 84.8%, respectively. The rate of adverse clinicopathological outcome features (pT3/4, ISUP ≥4, or prostate-specific antigen [PSA]-persistence) following RP was 4.7% for men with MRI negative compared to 17.4% for men with MRI positive PCa (OR = 3.1, p = 0.19). CONCLUSION: Only few men with MRI negative PCa need active cancer treatment at the time of diagnosis, while the majority opts for AS. Omitting prostate biopsies and performing a follow-up MRI may be a safe alternative to reduce the number of unnecessary interventions.

Fusion-targeted biopsy significantly improves prostate cancer detection in biopsy-naïve men.

OBJECTIVE: The precise diagnosis of prostate cancer (PC) is crucial to avoid underdiagnosis, overdiagnosis, and overtreatment. We aimed to compare clinically significant PC (csPC) detection between MRI/ultrasound fusion-targeted prostate (TBx) compared to systematic biopsy (SBx) in biopsy-naïve Japanese men. METHODS: We included patients with suspect PC due to elevated PSA level or abnormal digital rectal examination, or both. csPC was defined as International Society Urological Pathology (ISUP) grade group ≥2 (csPC-A) and ISUP grade group ≥3 (csPC-B). RESULTS: This study included 143 patients. Overall PC detection was 66.4% for SBx and 67.8% for MRI-TBx. MRI-TBx presented a significantly higher rate of csPC detection (csPC-A 67.1% vs. 58.7%, p = 0.04, and csPC-B 49.6% vs. 39.9%, p < 0.001) and significantly lower detection of non-csPC-A (0.6% vs. 6.7%). Importantly, MRI-TBx missed 4.9% (7/143) of csPC-A and only 0.7% (1/143) of csPC-B. On the other hand, SBx alone missed 13.3% (19/143) of csPC-A and 4.2% (6/143) of csPC-B. CONCLUSION: MRI-TBx significantly outperformed 12-cores SBx for csPC detection and decreased non-csPC detection in biopsy-naive men. Performing MRI-TBx without SBx would have missed some csPC, supporting that MRI-TBx synergizes with SBx to increase csPC detection.

Association between previous negative biopsies and lower rates of progression during active surveillance for prostate cancer.

PURPOSE: To test any-cause discontinuation and ISUP GG upgrading rates during Active Surveillance (AS) in patients that underwent previous negative biopsies (PNBs) before prostate cancer (PCa) diagnosis vs. biopsy naive patients. METHODS: Retrospective analysis of 961 AS patients (2008-2020). Three definitions of PNBs were used: (1) PNBs status (biopsy naïve vs. PNBs); (2) number of PNBs (0 vs. 1 vs. ≥ 2); (3) histology at last PNB (no vs. negative vs. HGPIN/ASAP). Kaplan-Meier plots and multivariable Cox models tested any-cause and ISUP GG upgrading discontinuation rates. RESULTS: Overall, 760 (79.1%) vs. 201 (20.9%) patients were biopsy naïve vs. PNBs. Specifically, 760 (79.1%) vs. 138 (14.4%) vs. 63 (6.5%) patients had 0 vs. 1 vs. ≥ 2 PNBs. Last, 760 (79.1%) vs. 134 (13.9%) vs. 67 (7%) patients had no vs. negative PNB vs. HGPIN/ASAP. PNBs were not associated with any-cause discontinuation rates. Conversely, PNBs were associated with lower rates of ISUP GG upgrading: (1) PNBs vs. biopsy naïve (HR:0.6, p = 0.04); (2) 1 vs. 0 PNBs (HR:0.6, p = 0.1) and 2 vs. 0 PNBs, (HR:0.5, p = 0.1); (3) negative PNB vs. biopsy naïve (HR:0.7, p = 0.3) and HGPIN/ASAP vs. biopsy naïve (HR:0.4, p = 0.04). However, last PNB ≤ 18 months (HR:0.4, p = 0.02), but not last PNB > 18 months (HR:0.8, p = 0.5) were associated with lower rates of ISUP GG upgrading. CONCLUSION: PNBs status is associated with lower rates of ISUP GG upgrading during AS for PCa. The number of PNBs and time from last PNB to PCa diagnosis (≤ 18 months) appear also to be critical for patient selection.

Primary magnetic resonance imaging/ultrasonography fusion-guided biopsy of the prostate.

OBJECTIVE: To examine the performance of a primary magnetic resonance imaging (MRI)/ultrasonography (US) fusion-guided targeted biopsy (TB), and in combination with an added systematic biopsy (SB). PATIENTS AND METHODS: Analysis of 318 consecutive biopsy-naïve men with suspicious multiparametric MRI (mpMRI; Prostate Imaging Reporting and Data System [PI-RADS] score ≥3) undergoing transrectal TB and 10-core SB between January 2012 and December 2016. The indication for performing mpMRI was based on clinical parameters and decided by the treating urologist before admission. TB was performed with a sensor-based MRI/US fusion-guided platform. Clinically significant prostate cancer was defined as Gleason score ≥4 + 3 = 7 (International Society of Urological Pathology Grade [ISUP] grade 3) or maximum cancer core length of ≥6 mm. RESULTS: A median (interquartile range) of 14 (13-14) biopsies per case were taken. The overall cancer detection rate (CDR) was 77% (245/318). The TB alone detected 67% of prostate cancers and the SB alone detected 70%. The PI-RADS dependent CDR for the combination of TB/SB were 38% (21/55), 78% (120/154) and 95% (104/109) for PI-RADS scores of 3/4/5, respectively. Clinically significant prostate cancer was diagnosed by the combination of TB and SB in 195 men (61%) and by TB alone in 163 cases (51%). The number of missed or underestimated prostate cancers with a Gleason score ≥8 for TB alone was 31 (10%, P < 0.001) and 21 (7%, P < 0.001) for SB alone in comparison with the results of the combination of TB and SB. The rate of insignificant prostate cancer was comparable for the combination of TB and SB and TB alone (50/318, 16% vs 50/318, 16%). CONCLUSIONS: Pre-biopsy mpMRI is of incremental value in increasing the detection of clinically significant prostate cancer in biopsy-naïve patients with suspicion of prostate cancer. Combining TB with SB further improved the diagnostic accuracy without increasing the rate of insignificant prostate cancer.

Clinical and Radiological Factors for Predicting Clinically Significant Prostate Cancer in Biopsy-Naive Patients With PI-RADS 3 Lesions.

OBJECTIVE: This study intends to examine the anticipatory power of clinical and radiological parameters in detecting clinically significant prostate cancer in patients demonstrating Prostate Imaging Reporting and Data System 3 lesions. METHODS: This was a retrospective study. The study included participation from 453 patients at the First Affiliated Hospital of Soochow University, sampled between September 2017 through August 2022. Each patient underwent a routine 12-core prostate biopsy followed by a 2 to 5 core fusion-targeted biopsy. We utilized both univariate and multivariate logistic regression analyses to identify the parameters that have a correlation with clinically significant prostate cancer. The predictive ability of these parameters was assessed using the receiver operating characteristic curve, leading to the creation of a nomogram. RESULTS: Clinically significant prostate cancer was detected in 68 out of 453 patients with Prostate Imaging Reporting and Data System 3 lesions (15.01%). Among Prostate Imaging Reporting and Data System 3a and 3b patients, 4.78% (3.09% of the total) and 33.75% (11.92% of the total), respectively, had clinically significant prostate cancer. Systematic biopsy improved prostate cancer and clinically significant prostate cancer detection rates by 7.72% and 3.09%, respectively, compared to targeted biopsy. Without systematic biopsy, there would be an undetected rate of 15% for prostate cancer and 8.13% for clinically significant prostate cancer in Prostate Imaging Reporting and Data System 3b patients. Several clinical parameters, including age, prostate-specific antigen density, lesion volume, apparent diffusion coefficient, and digital rectal examination, were statistically significant in the logistic regression analysis for clinically significant prostate cancer. The individual diagnostic accuracies of these parameters for clinically significant prostate cancer were 0.648, 0.645, 0.75, 0.763, and 0.7, respectively, but their combined accuracy improved to 0.866. A well-fit nomogram based on the identified risk factors was constructed (χ2 = 10.254, P = .248). CONCLUSION: The combination of age, prostate-specific antigen density, lesion volume, apparent diffusion coefficient, and digital rectal examination presented a higher diagnostic value for clinically significant prostate cancer than any single parameter in patients with Prostate Imaging Reporting and Data System 3 lesions. Systematic biopsy proved crucial for biopsy-naive patients with Prostate Imaging Reporting and Data System 3 lesions and should not be omitted.

Accuracy of MRI-ultrasound fusion-guided and systematic biopsy of the prostate.

OBJECTIVES: Prostate multiparametric MRI (mpMRI) with subsequent targeted biopsy of suspicious lesions has a critical role in the diagnostic workup of prostate cancer. The objective was to evaluate the diagnostic accuracy of systematic biopsies, targeted biopsies, and the combination of both in prostate cancer detection. METHODS: From January 1, 2013 to June 1, 2022, biopsy-naïve and prior biopsy-negative patients who underwent both systematic and targeted biopsies were included. MRIs were evaluated according to PI-RADS with biopsy threshold set at PI-RADS ≥3. Systematic biopsies consisted of 8-12 cores, based on prostate volume. Overall prostate cancer and clinically significant cancer (Gleason Score ≥3 + 4) detection rates were stratified based on PI-RADS and location within the prostate, and compared between biopsy types using McNemar test. RESULTS: Among 867 patients, 615 had prostate cancer, with 434 clinically significant cases. Overall detection rates were: PI-RADS 3 48%, PI-RADS 4 72%, and PI-RADS 5 90%. Detection rates for clinically significant cancer were 21%, 53%, and 72%, respectively. The combination of biopsy methods was most accurate in detecting clinically significant prostate cancer (P < .001). Targeted biopsies alone detected more clinically significant prostate cancer than systematic biopsies alone (43.1% vs 40.3%, P = .046). For posterior PI-RADS 5 lesions, no statistically significant difference was found between all biopsy methods. CONCLUSIONS: In the detection of clinically significant prostate cancer, the combination of systematic and targeted biopsies proves most effective. Targeted biopsies rarely missed significant cancer for posterior PI-RADS 5 lesions, suggesting systematic biopsies could be reserved for instances where targeted biopsy results are negative. ADVANCES IN KNOWLEDGE: This study emphasizes on the efficacy of mpMRI and targeted biopsies in suspected prostate cancer in real-world clinical context. For PI-RADS 5 lesions, systematic biopsies provide limited clinical benefit and may only be necessary when targeted biopsy results are negative.

The Added Value of MRI-Based Targeted Biopsy in Biopsy-Naïve Patients: A Propensity-Score Matched Comparison.

BACKGROUND: Multiparametric Magnetic Resonance Imaging (mpMRI)-based targeted biopsy has shown to be beneficial in detecting Clinically Significant Prostate Cancer (csPCa) and avoiding diagnosis of Non-csPCa (ncsPCa); however, its role in the treatment of biopsy-naïve patients is still under discussion. METHODS: After identifying predictors for the diagnosis of csPCa via Multivariate Logistic Regression Analysis (MLRA), a propensity-score (1:1 nearest neighbor) matched comparison was performed between a Systematic-Only Biopsy (SOB) cohort and a mpMRI-based Combined (systematic + targeted) Biopsy (CB) cohort from two tertiary urologic centers (SOB: Department of Urology, University General Hospital of Heraklion, University of Crete, School of Medicine, Heraklion, Crete, Greece; CB: LKH Hall in Tirol, Austria). Only biopsy-naïve patients were included in the study. The study period for the included patients was from February 2018 to July 2023 for the SOB group and from July 2017 to June 2023 for the CB group. The primary outcome was the diagnosis of csPCa (≥ISUP 2); secondary outcomes were overall cancer detection, the added value of targeted biopsy in csPCa detection, and the reduction in ncsPCa diagnosis with CB compared to SOB. To estimate the Average Treatment effect of the Treated groups (ATT), cluster-robust standard errors were used to perform g-computation in the matched sample. p-values < 0.05 with a two-sided 95% confidence interval were considered statistically significant. RESULTS: Matching achieved well-balanced groups (each n = 140 for CB and SOB). In the CB group, 65/140 (46.4%) patients were diagnosed with csPCa compared to 44/140 (31.4%) in the SOB group (RR 1.48, 95%-CI: 1.09-2.0, p = 0.01). In the CB group, 4.3% (6/140) and 1.4% (2/140) of csPCa cases were detected with targeted-only and systematic-only biopsy cores, respectively. In the CB group, 22/140 (15.7%) patients were diagnosed with ncsPCa compared to 33/140 (23.6%) in the SOB group (RR = 0.67, 95% CI: 0.41-1.08, p = 0.1). When comparing SOB to CB (ATT), the marginal OR was 0.56 (95% CI: 0.38-0.82, p = 0.003) for the diagnosis of csPCa and 0.75 (95% CI: 0.47-1.05, p = 0.085) for the diagnosis of overall cancer (≥ISUP 1). CONCLUSION: The CB approach was superior to the SOB approach in detecting csPCa, while no additional detection of ncsPCa was seen. Our results support the application of mpMRI for biopsy-naïve patients with suspicions of prostate cancer.

Prostate Biopsies Can Be Omitted in Most Patients with a Positive Stockholm3 Test and Negative Prostate Magnetic Resonance Imaging.

BACKGROUND: Magnetic resonance imaging (MRI) combined with the Stockholm3 test can be used to inform biopsy decision-making in patients with a suspicion of prostate cancer. OBJECTIVE: To determine the consequence of omitting biopsies in men with a positive Stockholm3 test and a negative MRI. DESIGN, SETTING, AND PARTICIPANTS: In a real-life setting, 438 men with a positive Stockholm3 test and a negative MRI underwent systematic biopsies from 2017 to 2020. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The Stockholm3 test result is a percentage risk score with or without a prostate volume cutoff. The main outcomes were the number of clinically significant (Gleason grade group [GG] ≥2) and nonsignificant (GG 1) prostate cancers. RESULTS AND LIMITATIONS: Median prostate-specific antigen was 4.5 ng/ml (interquartile range 2.8-6.4 ng/ml) and the median age was 69 yr. Systematic biopsies detected grade group (GG) ≥2 disease in 48 men (11%, 95% confidence interval [CI] 8.4-14.2%) and GG 1 disease in 94 men (21.5%, 95% CI 17.9-25.6%). Of 256 patients without a volume cutoff in the test report, GG ≥2 was detected in 37 men (14.5%, 95% CI 10.7-19.3%). Omitting biopsies in patients with a volume cutoff would miss 11 GG ≥2 cases (6%, 95% CI 3.4-10.5%), reduce the number of GG 1 cases detected by 37 (39.4%, 95% CI 30.1-49.5%), and avoid a total of 182 biopsies (41.6%, 95% CI 37.0-46.2%). Limitations include the lack of follow-up data. CONCLUSIONS: Systematic biopsies can be omitted in patients with a positive Stockholm3 test and a negative MRI when there is a volume cutoff in the test report. With no volume cutoff, biopsies can be considered with shared decision-making. PATIENT SUMMARY: When investigated on suspicion of prostate cancer with a positive Stockholm3 test and a negative MRI (magnetic resonance imaging), prostate biopsies are only necessary for a subgroup of patients. This can spare some men from undergoing biopsies and reduce the detection of clinically insignificant cancers.

Combining targeted and systematic prostate biopsy improves prostate cancer detection and correlation with the whole mount histopathology in biopsy naïve and previous negative biopsy patients.

Objective: Guidelines for previous negative biopsy (PNB) cohorts with a suspicion of prostate cancer (PCa) after positive multiparametric (mp) magnetic-resonance-imaging (MRI) often favour the fusion-guided targeted prostate-biopsy (TB) only approach for Prostate Imaging-Reporting and Data System (PI-RADS) ≥3 lesions. However, recommendations lack direct biopsy performance comparison within biopsy naïve (BN) vs. PNB patients and its prognostication of the whole mount pathology report (WMPR), respectively. We suppose, that the combination of TB and concomitant TRUS-systematic biopsy (SB) improves the PCa detection rate of PI-RADS 2, 3, 4 or 5 lesions and the International Society of Urological Pathology (ISUP)-grade predictability of the WMPR in BN- and PNB patients. Methods: Patients with suspicious mpMRI, elevated prostate-specific-antigen and/or abnormal digital rectal examination were included. All PI-RADS reports were intramurally reviewed for biopsy planning. We compared the PI-RADS score substratified TB, SB or combined approach (TB/SB) associated BN- and PNB-PCa detection rate. Furthermore, we assessed the ISUP-grade variability between biopsy cores and the WMPR. Results: According to BN (n = 499) vs. PNB (n = 314) patients, clinically significant (cs) PCa was detected more frequently by the TB/SB approach (62 vs. 43%) than with the TB (54 vs. 34%) or SB (57 vs. 34%) (all p < 0.0001) alone. Furthermore, we observed that the TB/SB strategy detects a significantly higher number of csPCa within PI-RADS 3, 4 or 5 reports, both in BN and PNB men. In contrast, applied biopsy techniques were equally effective to detect csPCa within PI-RADS 2 lesions. In case of csPCa diagnosis the TB approach was more often false-negative in PNB patients (BN 11% vs. PNB 19%; p = 0.02). The TB/SB technique showed in general significantly less upgrading, whereas a higher agreement was only observed for the total and BN patient cohort. Conclusion: Despite csPCa is more frequently found in BN patients, the TB/SB method always detected a significantly higher number of csPCa within PI-RADS 3, 4 or 5 reports of our BN and PNB group. The TB/SB strategy predicts the ISUP-grade best in the total and BN cohort and in general shows the lowest upgrading rates, emphasizing its value not only in BN but also PNB patients.

Magnetic Resonance Imaging-targeted Prostate Biopsy Compared with Systematic Prostate Biopsy in Biopsy-naïve Patients with Suspected Prostate Cancer.

Background: It remains uncertain whether transrectal ultrasound (TRUS)-guided systematic biopsies can be omitted and rely solely on multiparametric magnetic resonance imaging-targeted biopsies (MRI-TBx) in biopsy-naïve men suspected of prostate cancer (PCa). Objective: To compare PCa detection in biopsy-naïve men between systematic biopsy and MRI-TBx. Design setting and participants: A prospective cohort study was conducted in a Dutch teaching hospital. Consecutive patients with suspected PCa, no history of biopsy, and no clinical suspicion of metastasis underwent both TRUS-guided systematic biopsies and MRI-TBx by multiparametric magnetic resonance imaging (mpMRI)-ultrasound fusion, including sham biopsies in case of negative mpMRI. Outcome measurements and statistical analysis: Clinically significant PCa (csPCa), defined as group ≥2 on the International Society of Urological Pathology grading, was detected. Results and limitations: The overall prevalence of csPCa, irrespective of biopsy technique, was 37.4% (132/353) in our population. MRI-TBx were performed in 263/353 (74.5%) patients with suspicious mpMRI (Prostate Imaging Reporting and Data System [PI-RADS] ≥3). The detection rates for csPCa were 39.5% for MRI-TBx and 42.9% for systematic biopsies. The added values, defined as the additional percentages of patients with csPCa detected by adding one biopsy technique, were 8.7% for the systematic biopsies and 5.3% for MRI-TBx. In patients with nonsuspicious mpMRI, five cases (6%) of csPCa were found by systematic biopsies. Conclusions: This study in biopsy-naïve patients suspected for PCa showed that systematic biopsies have added value to MRI-TBx alone in patients with mpMRI PI-RADS >2. Patient summary: We studied magnetic resonance imaging (MRI)-guided prostate biopsy for diagnosing prostate cancer and compared it with the standard method of prostate biopsy. Standard systematic biopsies cannot be omitted in patients with suspicious MRI, as they add to the detection of significant prostate cancer.

Use of Prostate Systematic and Targeted Biopsy on the Basis of Bi-Parametric Magnetic Resonance Imaging in Biopsy-Naïve Patients.

OBJECTIVES: To explore the performance of targeted biopsy (TB) in combination with systematic biopsy (SB) in the detection of prostate cancer (PCa) in biopsy naïve patients. METHODS: From May 2018 to January 2020, 230 biopsy-naïve men with suspicious bi-parametric MRI [bpMRI; Prostate Imaging Reporting and Data System (PI-RADS) score ≥3] were enrolled. All patients had prostate-specific antigen (PSA) levels of 20 ng/ml or less. For each patient, transrectal ultrasound-guided prostate biopsy was performed. The primary endpoint was the detection rate of CSPC [clinically-significant PCa, International Society of Urological Pathology grade group (ISUP GG) 2 or higher tumors]. The secondary endpoints were the detection rates of CIPC (clinically insignificant PCa, ISUP GG 1 tumors). RESULTS: CSPC was detected in 90 patients. Twelve (13.33%) of them were detected by TB only and 18 (20.00%) by SB only. Detection of CSPC by SB and TB did not differ significantly (p = .36). In 4.35% of 230 patients, CSPC would have been missed if we performed SB only, and in 6.09% of patients if we performed TB only. Moreover, combination of TB and SB did not increase the detection of CIPC. CONCLUSIONS: No significant difference was found in the detection of CSPC between TB and SB; however, both techniques revealed substantial added value and combination of TB and SB could further improve this detection rate without increasing the detection of CIPC.

Implications of the European Association of Urology Recommended Risk Assessment Algorithm for Early Prostate Cancer Detection.

The 2021 European Association of Urology recommendations for early prostate cancer detection included a risk-based algorithm. Risk assessment methods are proposed to prevent excessive use of prostate magnetic resonance imaging (MRI) and biopsy, simultaneously reducing overdiagnosis and overtreatment. However, the clinical implications of sequential use of risk assessment tests have not yet been properly assessed. We provide an appraisal of the recommended algorithm and evaluate its outcomes in a contemporary prospective study population of biopsy-naïve men. To increase the effectiveness in cases of limited MRI capacity, we show that use of the Rotterdam Prostate Cancer Risk Calculator-3 for pre-MRI risk stratification could avoid more than one-third of MRI examinations. After prostate MRI, use of either the Prostate Imaging-Reporting and Data System (PI-RADS) score or a risk model including MRI outcome as a variable could avoid six out of ten prostate biopsies while maintaining high sensitivity. However, implementation in health care systems requires due consideration of the access to and quality of diagnostic resources, as well as cost-effectiveness. Patient summary: We evaluated the European Association of Urology risk-based strategy for early prostate cancer detection. Risk assessment before magnetic resonance imaging (MRI) using a risk calculator or prostate-specific antigen (PSA) density could reduce MRI demands and overdiagnosis of insignificant cancers. Risk assessment using prostate MRI results could avoid 60% of prostate biopsies while maintaining prostate cancer detection rates.The European Association of Urology (EAU) recently published its current position and recommendations on prostate-specific antigen (PSA) testing [1]. On the basis of the literature and expert opinion, a risk-based algorithm for early detection of prostate cancer (PCa) was proposed. The guideline recommends stratifying men with PSA ≥3 ng/ml as either "low risk", for whom magnetic resonance imaging (MRI) can be avoided, or "intermediate and high risk", for whom prostate MRI should be performed as a basis for further diagnostic decisions. Strategies must be developed to use health care resources efficiently and to reduce unnecessary morbidity, anxiety, and costs of diagnostics. However, any paradigm shift inevitably leads to a paucity of research data. As a result, there is still debate regarding which men can safely avoid an initial MRI but are subjected to clinical follow-up, and which men must undergo an immediate MRI. The authors proposed four methods for risk assessment: (1) family history; (2) PSA velocity; (3) PSA density; and (4) risk calculators. It must be stressed that the availability and quality of prostate MRI in each situation should be considered when using these pre-MRI risk assessment tools. We discuss in brief the proposed risk assessment methods including MRI and assess potential outcomes in a contemporary population.

Performance of Combined Magnetic Resonance Imaging/Ultrasound Fusion-guided and Systematic Biopsy of the Prostate in Biopsy-naïve Patients and Patients with Prior Biopsies.

BACKGROUND: As recent prospective studies showed targeted biopsies (TBs) to be superior to systematic biopsies (SBs), magnetic resonance imaging (MRI) is gaining wider acceptance in the diagnostic setup of prostate cancer (PCa). OBJECTIVE: To examine the performance of MRI/ultrasound fusion-guided TB in combination with SB in the detection of PCa in patients with and without prior biopsy. DESIGN, SETTING, AND PARTICIPANTS: A total of 219 men undergoing combined transrectal TB and 12-core SB from February 2014 to November 2018 were analysed. For all patients showing a suspicion of PCa in multiparametric MRI, TB was performed using fusion imaging with real-time virtual sonography. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Cancer detection rates (CDRs) and significant CDRs for TB, SB, and TB+SB were analysed. Further stratification was performed for a number of previous biopsy sessions and Prostate Imaging Reporting and Data System (PI-RADS) score. Significant PCa was defined as any PCa with Gleason score ≥3+4. RESULTS AND LIMITATIONS: Of all, 141 patients were biopsy naïve, while 78 patients had at least one prior biopsy. Median prostate-specific antigen (PSA) level prior to biopsy was 8.4ng/ml (interquartile range 5.5-11.8ng/ml). The overall CDR was 63.5% (139/219), while the PI-RADS-dependent CDRs for the combination of TB+SB were 29.1%, 67.7%, and 86.2% for patients with PI-RADS 3, 4, and 5, respectively. Looking at TB or SB alone, CDRs were 55.7% and 57.5%. The overall CDR for significant PCa was 51.6%. (18.2%, 50.5%, and 81.5% for PI-RADS 3, 4, and 5, respectively). CDRs were significantly higher for biopsy-naïve patients (65.2% vs 67.4% vs 71.6% for TB vs SB vs TB+SB) than for patients with one previous negative biopsy (38.2% vs 43.6% vs 50.9% for TB vs SB vs TB+SB; all p<0.01). CONCLUSIONS: Multiparametric MRI can raise the CDR in patients with and without biopsies performed earlier. With higher PI-RADS lesions, the risk of harbouring PCa increases. Combining TB with SB further improved the diagnostic accuracy in biopsy-naïve patients and after one previous negative biopsy. PATIENT SUMMARY: Multiparametric magnetic resonance imaging before prostate biopsy increases cancer detection rates in biopsy-naïve patients and patients with a previous negative biopsy. The combination of targeted biopsy with systematic biopsy improved the diagnostic accuracy in biopsy-naïve patients and after one previous negative biopsy.

Combined Use of Prostate-specific Antigen Density and Magnetic Resonance Imaging for Prostate Biopsy Decision Planning: A Retrospective Multi-institutional Study Using the Prostate Magnetic Resonance Imaging Outcome Database (PROMOD).

BACKGROUND: Previous studies suggested that prostate-specific antigen (PSA) density (PSAd) combined with magnetic resonance imaging (MRI) may help avoid unnecessary prostate biopsy (PB) with a limited risk of missing clinically significant prostate cancer (csPCa; Gleason grade group [GGG] >1). OBJECTIVE: To define optimal diagnostic strategies based on the combined use of PSAd and MRI in patients at risk of prostate cancer (PCa). DESIGN, SETTING, AND PARTICIPANTS: A retrospective analysis of the international multicenter Prostate MRI Outcome Database (PROMOD), including 2512 men having undergone PSAd and prostate MRI before PB between 2013 and 2019, was performed. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Rates of avoided PB, missed GGG 1, and csPCa according to 10 strategies based on PSAd values and MRI reporting scores (Prostate Imaging Reporting and Data System [PI-RADS]/Likert/IMPROD biparametric prostate MRI Likert). Decision curve analysis (DCA) was used to statistically compare the net benefit of each strategy. Combined systematic and targeted biopsies were used for reference. RESULTS AND LIMITATIONS: According to DCA, the best strategy in biopsy-naive patients was #7 (PI-RADS/Likert 4-5 or PI-RADS/Likert 3 if PSAd >0.2), which avoided 41.2% PBs while missed 44% of GGG 1 and 10.9% of csPCa cases. From a clinical standpoint, however, strategies with a lower risk of missing csPCa included #10 (PI-RADS/Likert 4-5 or PI-RADS 3 if PSAd >0.10 or PSAd >0.2), which avoided 27% PBs while missing 24.4% GGG 1 and 4% csPCa cases, or #5 (PI-RADS/Likert 3-5 or PSAd>0.15), which avoided 14.7% PBs while missing 9.3% GGG 1 and 1.7% csPCa cases. Similar results were found in patients with a previous negative biopsy. This study is limited by its retrospective nature, and no central review of MRI and histopathological findings. CONCLUSIONS: Combined PSAd and MRI findings allows individualization of the decision to perform PB on the basis of the risk of missing PCa that both patients and clinicians are ready to accept to avoid this procedure. PATIENT SUMMARY: We compared several biopsy strategies based on a combination of prostate magnetic resonance imaging findings and prostate-specific antigen density, providing a readily available tool for each center and practicing urologist to counsel patients about their individual risk of significant prostate cancer.

Detection of prostate cancer using prostate imaging reporting and data system score and prostate-specific antigen density in biopsy-naive and prior biopsy-negative patients.

BACKGROUND: Few studies report on indications for prostate biopsy using Prostate Imaging-Reporting and Data System (PI-RADS) score and prostate-specific antigen density (PSAD). No study to date has included biopsy-naïve and prior biopsy-negative patients. Therefore, we evaluated the predictive values of the PI-RADS, version 2 (v2) score combined with PSAD to decrease unnecessary biopsies in biopsy-naïve and prior biopsy-negative patients. MATERIALS AND METHODS: A total of 1,098 patients who underwent multiparametric magnetic resonance imaging at our hospital before a prostate biopsy and who underwent their second prostate biopsy with an initial benign negative prostatic biopsy were included. We found factors associated with clinically significant prostate cancer (csPca). We assessed negative predictive values by stratifying biopsy outcomes by prior biopsy history and PI-RADS score combined with PSAD. RESULTS: The median age was 65 years (interquartile range: 59-70), and the median PSA was 5.1 ng/mL (interquartile range: 3.8-7.1). Multivariate logistic regression analysis revealed that age, prostate volume, PSAD, and PI-RADS score were independent predictors of csPca. In a biopsy-naïve group, 4% with PI-RADS score 1 or 2 had csPca; in a prior biopsy-negative group, 3% with PI-RADS score 1 or 2 had csPca. The csPca detection rate was 2.0% for PSA density <0.15 ng/mL/mL and 4.0% for PSA density 0.15-0.3 ng/mL/mL among patients with PI-RADS score 3 in a biopsy-naïve group. The csPca detection rate was 1.8% for PSA density <0.15 ng/mL/mL and 0.15-0.3 ng/mL/mL among patients with PI-RADS score 3 in a prior biopsy-negative group. CONCLUSION: Patients with PI-RADS v2 score ≤2, regardless of PSA density, may avoid unnecessary biopsy. Patients with PI-RADS score 3 may avoid unnecessary biopsy through PSA density results.

Targeted and Systematic Prostate Biopsy in Biopsy-naive Men With Positive Multiparameter Magnetic Resonance Imaging Findings: A Meta-analysis.

We assessed the difference in the detection rate of prostate cancer, specifically clinically significant prostate cancer, using targeted biopsy (TB), systematic biopsy (SB), and the combination of these 2 (CB) in biopsy-naive men with positive multiparameter magnetic resonance imaging results. We performed a literature review in September 2018 using PubMed and the Web of Science. Relevant studies acquired from specific articles' references were also reviewed. Only those studies that had provided the detection rate of TB, SB, and CB in biopsy-naive men with positive multiparameter magnetic resonance imaging findings were included for a total of 11 studies with 2099 patients. The combined strategy was better than TB or SB alone, with an odds ratio (OR) of 1.47 (95% confidence interval [CI], 1.30-1.67; P < .001) and 1.45 (95% CI, 1.28-1.65; P < .001), respectively, in the overall detection rate. Also, TB was not better than SB, with an OR of 0.99 (95% CI, 0.87-1.12; P = .825). For the clinically significant prostate cancer detection rate, CB was still better than TB or SB alone, with an OR of 1.25 (95% CI, 1.11-1.42; P < .001) and an OR of 1.23 (95% CI, 1.08-1.40; P = .002), respectively. Again, TB was not better than SB, with an OR of 0.98 (95% CI, 0.86-1.12; P = .768). In conclusion, CB resulted in a better detection rate than TB or SB alone for both the overall prostate cancer detection rate and the clinically significant prostate cancer detection rate.

Complication Rates After TRUS Guided Transrectal Systematic and MRI-Targeted Prostate Biopsies in a High-Risk Region for Antibiotic Resistances.

Introduction: There is still an ongoing debate whether a transrectal ultrasound (TRUS) approach for prostate biopsies is associated with higher (infectious) complications rates compared to transperineal biopsies. This is especially of great interests in settings with elevated frequencies of multidrug resistant organisms (MDRO). Materials and Methods: Between 01/2018 and 05/2019 230 patients underwent a TRUS-guided prostate biopsy at the department of Urology at University Hospital Frankfurt. Patients were followed up within the clinical routine that was not conducted earlier than 6 weeks after the biopsy. Among 230 biopsies, 180 patients took part in the follow-up. No patients were excluded. Patients were analyzed retrospectively regarding complications, infections and underlying infectious agents or needed interventions. Results: Of all patients with follow up, 84 patients underwent a systematic biopsy (SB) and 96 a targeted biopsy (TB) after MRI of the prostate with additional SB. 74.8% of the patients were biopsy-naïve. The most frequent objective complications (classified by Clavien-Dindo) lasting longer than one day after biopsy were hematuria (17.9%, n = 32), hematospermia (13.9%, n = 25), rectal bleeding (2.8%, n = 5), and pain (2.2%, n = 4). Besides a known high MDRO prevalence in the Rhine-Main region, only one patient (0.6%) developed fever after biopsy. One patient each (0.6%) consulted a physician due to urinary retention, rectal bleeding or gross hematuria. There were no significant differences in complications seen between SB and SB + TB patients. The rate of patients who consulted a physician was significantly higher for patients with one or more prior biopsies compared to biopsy-naïve patients. Conclusion: Complications after transrectal prostate biopsies are rare and often self-limiting. Infections were seen in <1% of all patients, regardless of an elevated local prevalence of MDROs. Severe complications (Clavien-Dindo ≥ IIIa) were only seen in 3 (1.7%) of the patients. Repeated biopsy is associated with higher complication rates in general.

PSA-density does not improve bi-parametric prostate MR detection of prostate cancer in a biopsy naïve patient population.

PURPOSE: Bi-parametric prostate MR (bp-MR) is a valuable tool for detection and characterization of prostate cancer (PCa). Recent studies suggested that PSA-density (PSA-D) in combination with multi-parametric prostate MR as well as bp-MR may achieve a higher diagnostic accuracy than either alone. We aimed to evaluate the diagnostic performance of bp-MR, PSA-D and their combination in biopsy-naïve patients. METHODS AND MATERIALS: We retrospectively analyzed 334 consecutive patients who underwent prostate MR on a 3T scanner. Only patients (n = 114) who underwent TRUS-biopsy within 30 days following MR with no previous prostate biopsies were considered. Our protocol included T2-weighted and DWI sequences. A Likert score based on PI-RADS v2 was used for bp-MR evaluation. Lesions were graded histopathologically using the ISUP score. We assessed three scenarios: detection of lesions independently of ISUP score (ISUP ≥ 1), detection of both intermediate and clinically significant lesions (ISUP ≥ 2) and detection of clinically significant lesions alone (ISUP ≥ 3). Predictive value of bp-MR and PSA-D was evaluated by ROC curves and logistic regression analysis. A p value < 0.05 was considered statistically significant. RESULTS: In all evaluated scenarios, bp-MR showed a significantly higher predictive power (AUC = 0.87-0.95) compared to the performance of PSA-D (AUC = 0.73-0.79), while their combination (AUC = 0.91-0.95) showed no statistically significant improvement compared to bp-MR alone. CONCLUSION: Our results confirm that bp-MR is a powerful tool in detection of clinically significant PCa. Contrary to findings in the recent literature, PSA-D does not appear to significantly improve its diagnostic performance.