Systematic Biopsy Research Articles

Oncological Outcomes of Partial Gland Ablation Using High-Intensity Focused Ultrasound After Additional Confirmatory Transperineal Mapping Biopsy in Men with Prostate Cancer

Background/Objectives: To evaluate whether additional confirmatory transperineal mapping biopsy (TPMB) in men with localized prostate cancer (PCa) alters the treatment plan and outcome of partial gland ablation (PGA) using high-intensity focused ultrasound (HIFU). Methods: We retrospectively reviewed data from 96 patients who underwent PGA using HIFU between January 2020 and June 2022. After multiparametric magnetic resonance imaging (mpMRI), all men underwent transrectal ultrasound (TRUS)-guided, cognitive-targeted biopsy and systematic biopsy. Men eligible for PGA using HIFU first underwent confirmatory TPMB. Any changes in the treatment plan after TPMB were analyzed. Follow-up TRUS-guided biopsy was performed 1 year post-operatively to evaluate oncological outcomes. Clinically significant PCa (csPCa) was defined as Gleason grade (GG) ≥ 2. Results: Among all subjects, the median age (IQR) was 65.0 (60.0–72.0) years and the prostate-specific antigen level was 5.20 (3.71–7.81) ng/mL. The results of both TRUS-guided biopsy and TPMB led to a change in the treatment plan (from unilateral to bilateral PGA) for 13 (13.5%) patients. The 1-year follow-up TRUS-guided biopsy identified PCa in 13 (13.5%) patients, and csPCa in 7 (7.3%) patients. The infield- and outfield-positive rates were 8.3% (8/96) and 3.1% (3/96), respectively, for any PCa, and 3.1% (3/96) and 2.1% (2/96), respectively, for csPCa. Conclusions: Confirmatory TPMB results in better disease identification and localization, thereby affecting the treatment plan and improving oncological outcomes. Therefore, confirmatory TPMB should be considered to establish an appropriate strategy for patients with localized PCa eligible for PGA using HIFU.

The Role of Digital Rectal Examination for Early Detection of Significant Prostate Cancer in the Era of Magnetic Resonance Imaging

The role of digital rectal examination (DRE) in the early detection of significant prostate cancer (PCa) is being questioned in the era of magnetic resonance imaging (MRI). However, some men with suspected PCa may still be identified solely through DRE, even with low serum prostate-specific antigen (PSA) levels. Additionally, most predictive models designed to improve significant PCa diagnostic pathways incorporate DRE findings. We assessed the role of DRE among 5005 men with serum PSA levels > 3.0 ng/mL and/or suspicious DRE findings, who underwent pre-biopsy MRI and targeted and/or systematic biopsies, as part of the significant PCa opportunistic screening program in Catalonia (Spain) between 2016 and 2023. Significant PCa, defined as grade group > 2, was detected in 2097 men (41.9%). Suspicion of PCa was based solely on DRE in 206 cases (4.1%) with significant PCa detected in 50 of them (2.4%). Two pathways using the Barcelona predictive models, before and after MRI, with and without DRE findings showed specificities of 52.8 and 38.7%, respectively (p < 0.001), after fixing sensitivity at 90%. Prostate biopsy was avoided in 35.1 and 26.7%, respectively (p < 0.001), while its efficacy increased from 52.8 to 58%. We conclude that DRE improved the effectiveness of an opportunistic significant PCa-screening program.

Identifying the best candidate for focal therapy: a comprehensive review.

Despite the evidence supporting the use of focal therapy (FT) in patients with localized prostate cancer (PCa), considerable variability exists in the patient selection criteria across current studies. This study aims to review the most recent evidence concerning the optimal approach to patient selection for FT in PCa. PubMed database was systematically queried for studies reporting patient selection criteria in FT for PCa before December 31, 2023. After excluding non-relevant articles and a quality assessment, data were extracted, and results were described qualitatively. There is no level I evidence regarding the best patient selection approach for FT in patients with PCa. Current international multidisciplinary consensus statements recommend multiparametric magnetic resonance imaging (mpMRI) followed by MRI-targeted and systematic biopsy for all candidates. FT may be considered in clinically localized, intermediate risk (Gleason 3 + 4 and 4 + 3), and preferably unifocal disease. Patients should have an acceptable life expectancy. Those with prostate volume >50 ml and erectile dysfunction should not be excluded from FT. Prostate-specific antigen (PSA) level of < 20 (ideally < 10) ng/mL is recommended. However, the utility of other molecular and genomic biomarkers in patient selection for FT remains unknown. FT may be considered in well-selected patients with localized PCa. This review provides a comprehensive insight regarding the optimal approach for patient selection in FT.

Targeted Biopsy Is Sufficient for Men on Active Surveillance for Early-Stage Prostate Cancer.

Serial biopsy is a mainstay for patients on active surveillance (AS) for prostate cancer. mpMRI targeting has become a standard. It is unclear whether targeted biopsy alone reliably identifies the dominant lesion, thereby obviating the need for systematic sampling. Participants enrolled in AS with early-stage prostate cancer (PSA < 20, cT1-2, GG1-2) and underwent 2+ systematic biopsy sessions with or without MR-targeted sampling. The findings for dominant Gleason Grade (GG) and tumor localization were assessed. Among 821 men who underwent MR fusion biopsies, 82% were diagnosed with GG1 and 18% with GG2. Sixty-two percent had their first MR fusion biopsy as diagnostic or confirmatory. Across all fusion biopsies, MRI-targeted detection of GG and/or tumor location overlapped with systematic sampling for 95% of cases. For 5% of cases, systematic biopsy was unique in detecting GG and location outside the target. Most unique lesions detected outside the target had marginally aggressive features: 73% GG2 of low-volume and favorable histologic subtypes. In men with MR fusion biopsies, targeting alone identified the dominant GG and location most of the time (95%); 25% of dominant lesions were contiguous to the target, suggesting that better sampling of the target improves detection. The remaining 5% of men had higher-grade, low-volume disease outside the targeted lesion of which only 2% had aggressive risk features. MR fusion targeting, without systematic sampling, may be sufficient to monitor men on AS. Few high-risk cancers are missed, all of limited volume and favorable histology.

Surveillance after Focal Therapy - a Comprehensive Review.

to date, no standardized, evidence-based follow-up schemes exist for the monitoring of patients who underwent focal therapy (FT) and expert centers rely mainly on their own experience and/or institutional protocols. We aimed to perform a comprehensive review of the most advantageous follow-up strategies and their rationale after FT for prostate cancer (PCa). a narrative review of the literature was conducted to investigate different follow-up protocols of FT for PCa. Outcomes of interest were post-ablation oncological and functional outcomes and complications. Oncological success after FT was generally defined as the biopsy-confirmed absence of clinically significant PCa in the treated zone. De novo PCa in the untreated area usually reflects an inaccurate patient selection and should be treated as primary PCa. During follow-up, oncological outcomes should be evaluated with periodic PSA, multiparametric MRI and prostate biopsy. The use of PSA derivatives and new biomarkers is still controversial and therefore not recommended. The first MRI after FT should be performed between 6-12 months to avoid ablation-related artifacts and diagnostic delay in case of FT failure. Other imaging modalities, such as PSMA PET/CT scan, are promising but still need to be validated in the post-FT setting. A 12-month "for-protocol" prostate biopsy, including targeted and systematic biopsy, was generally considered the preferred biopsy method to rule out tumor persistence/recurrence. Subsequent mpMRIs and biopsies should follow a risk-adapted approach depending on the clinical scenario. Functional outcomes should be periodically assessed using validated questionnaires within the first year, when typically recover to a new baseline. Complications, despite uncommon, should be strictly monitored mainly in the first month. FT follow-up is a multifaceted process involving clinical, radiological, and histological assessment. Studies evaluating the impact of different follow-up strategies and ideal timings are needed to produce standardized protocols following FT.

Is Confirmatory Biopsy Still Necessary for Active Surveillance of Men With Grade Group 1 Prostate Cancer in the Era of Multiparametric Magnetic Resonance Imaging?

Men diagnosed with prostate cancer (PCa) considering active surveillance (AS) are recommended confirmatory biopsy (CBx). Whether this is necessary in the era of MRI-informed biopsies is questionable. We studied men with Grade Group [GG] 1 PCa at diagnostic biopsy (DBx) considering AS who underwent MRI and CBx (systematic + targeted) within 18 months. Outcomes were grade reclassification to GG ≥ 2, GG ≥ 3, and reclassification to unfavorable intermediate risk disease (UIR). Subset analyses were performed for men with (1) MRI prior to DBx and (2) MRI after DBx. Five hundred twenty-two men had GG1 PCa at DBx. At CBx, 20% reclassified to GG ≥ 2, 12% to UIR, and 5.6% to GG ≥ 3. Of the 306 with positive MRI (PI-RADS > 3), 27% reclassified to GG ≥ 2 and 16% to UIR disease; men with negative MRI experienced these outcomes at rates of 9.2% and 5.5%. There were no differences in reclassification outcomes based on MRI timing (group A vs B), and neither PSA density nor prostate volume added to MRI information. In men with MRI targets, approximately 1/3 of GG > 2 reclassification events were only captured by systematic biopsy core(s). Reclassification rates at CBx were high in men with positive MRI, but < 10% for all reclassification outcomes in men with negative MRI (95% CI 5.8%-14% for GG > 2, 2.9%-10% for UIR, 0.8%-5.3% for GG > 3). Our data support systematic + targeted CBx for men with positive MRI considering AS, while men with GG1 cancer and negative MRI should be able to defer CBx.

MRI-Directed Fusion Prostate Biopsy Strategies: Comparison of Targeted Biopsy Alone Versus Targeted With Ipsilateral or Bilateral Systematic Biopsy, by mpMRI or bpMRI Targeting.

MRI-Directed Fusion Prostate Biopsy Strategies: Comparison of Targeted Biopsy Alone Versus Targeted With Ipsilateral or Bilateral Systematic Biopsy, by mpMRI or bpMRI Targeting.

Comparison between 18F-DCFPyL PET/MRI-guided ultrasound fusion targeted biopsy and systematic biopsy for tumor detection and grading in selected patients: A prospective randomized controlled trial

ObjectiveTo compare the upgrade rate and cancer detection rate between 18F-DCFPyL PET/MRI-guided ultrasound fusion targeted biopsy and systematic biopsy in selected patients with suspected prostate cancer (the multiparametric MRI prostate imaging reporting and data system score ≥4 and molecular imaging prostate-specific membrane antigen score of prostate-specific membrane antigen PET image ≥2). MethodsEighty-seven selected biopsy-naive patients were randomized into two groups: targeted biopsy (n=41) and systematic biopsy (control; n=46). Those with negative initial results underwent a repeat biopsy using the alternative method. Patients diagnosed with clinically significant prostate cancer proceed to radical prostatectomy. The primary outcome was the upgrade rate. Additional outcomes, including the cancer detection rate, incidence of repeat biopsy, positive surgical margin, complications, and prostate-specific antigen level at 6 weeks postoperatively, were compared between the groups using Pearson or Fisher's exact tests, as appropriate. ResultsIn the study, prostate cancer was ultimately detected in all patients. The targeted biopsy group successfully identified all tumors, whereas five patients in the control group initially missed their tumors. The pathological upgrade rates for the targeted biopsy and control groups were 31.7 % and 56.5 %, respectively. Overall, the detection rate for clinically significant prostate cancer (the International Society of Urological Pathology grade ≥2) was significantly higher in the targeted biopsy group (92.7 %) compared with the control group (76.1 %, p=0.035). However, no significant difference was found in the detection rate of all prostate cancer. Complications (Clavien–Dindo grade ≤2) occurred in both the targeted biopsy group (n=11) and the control group (n=13). No statistically significant difference was observed between the groups in terms of positive surgical margin, complications, and 6-week postoperative prostate-specific antigen level. The main limitation is the small population. Conclusion18F-DCFPyL PET/MRI-guided ultrasound fusion targeted biopsy alone was an efficient modality in diagnosing selected patients with prostate cancer.

Factors influencing urinary retention following freehand transperineal prostate biopsy: Insights from a tertiary care center study

ABSTRACT Objectives: In this study, we evaluated the risk factors for urinary retention after freehand transrectal ultrasound (TRUS) guided transperineal prostate biopsy (TPB). Patients and Methods: Data from 102 cases of freehand TPB at a single institution were retrospectively collected and analyzed. All patients underwent magnetic resonance imaging (MRI)-TRUS cognitive fusion TPB using a transperineal needle guide, with systematic biopsies from 10 prostate sectors and additional MRI-guided targeted biopsies. Exclusions comprised patients with coagulation abnormalities, prior prostate surgeries including biopsy, active urinary tract infection, or a lack of pre-biopsy multiparametric MRI. Results: 14/102 (13.72%) had urinary retention and required urethral catheterization for voiding difficulty or discomfort along with a bladder volume of ≥500 ml. Patients with retention exhibited significantly larger prostate volumes (median 75 cc vs. 40 cc; P &lt; 0.05). Receiver operating curve analysis revealed a prostate volume threshold of 57.5 cc and a core number cutoff of 23 for predicting post-TPB urinary retention, with sensitivities of 78.57% and 85.71%, specificities of 75% and 82.95%, positive predictive values of 33.33% and 44.44%, and negative predictive values of 95.75% and 97.33%, respectively, whereas the number of biopsy cores correlated positively with the development of urinary retention (median 25 vs. 22; P &lt; 0.05). Urinary retention was independent of the patient’s age, comorbidities, presenting prostate-specific antigen levels, prebiopsy severity of lower urinary tract symptoms, and use of alpha-blockers. Conclusion: Patients with larger prostates and higher number of biopsy cores are at a higher risk of postfreehand TPB urinary retention and should receive appropriate counselling. Targeted biopsies alone, rather than a full template, may help mitigate urinary retention in these high-risk groups.

Concordance Between the Expert Reading of Biparametric-MRI and the Nonexpert Multiparametric-MRI for the Detection of Clinically Significant Prostate Cancer: Clinical Implications

PurposeProstate-magnetic resonance imaging (MRI) interpretation is challenging, with expertise playing a crucial role. Biparametric MRI (bpMRI) is gaining popularity in experienced centers due to its time and cost advantages over multiparametric MRI (mpMRI). We aim to analyze concordance between nonexpert radiologist PI-RADS from mpMRI and expert radiologist PI-RADS from bpMRI, and its clinical implications. Material and Methods222 men suspected of having prostate cancer (PCa) and mpMRI reported by nonexpert radiologists were referred to a reference center for transperineal MRI-TRUS fusion biopsy where an expert radiologist reported bpMRI PI-RADS 2.1 and segmentation, blinded to external mpMRI. Mapping targeted suspected lesions and 12-core systematic biopsies were performed. Clinically significant PCa (csPCa) was diagnosed when ISUP-grade group was ≥2. ResultsConcordance between both PI-RADS existed in 49.1% of cases (Kappa index 0.288). In 102 cases (45.9%), expert reclassification to lower PI-RADS existed, while an increase existed in 11 cases (5.0%), P < .001. Agreement existed in 30.8% of nonexpert PI-RADS 3, 43.6% of PI-RADS 4, and 83.7% of PI-RADS 5, P < .001. Potential clinical implications included 27% reduction in prostate biopsies when using expert bpMRI readings compared to nonexpert mpMRI readings (P < 0.001), while undetected csPCa were 4.2% and 3.4%, respectively, P = .669. Over-detection reduction of insignificant PCa was 29.4% and 0%, respectively, P = .034. ConclusionsConcordance between nonexpert PI-RADS mpMRI and expert PI-RADS bpMRI was low, increasing with nonexpert PI-RADS. Expert reclassification would reduce prostate biopsies by more than one quarter and over-detection of iPCa, while csPCa detection remained similar.

Early experience with targeted and combination biopsies in prostate cancer work-up in Denmark from 2012 to 2016

PurposeTo investigate the early implementation of combined systematic and targeted (cBx) primary biopsy in prostate cancer diagnosis and define the concordance in Gleason grading (GG) of different biopsy techniques with radical prostatectomy (RP) pathology.MethodsThis population-based analysis includes data on all men in Denmark who underwent primary cBx or standalone systematic (sBx) prostate biopsy between 2012 and 2016. Biopsy results were compared to RP pathology if performed within a year. Concordance measurement was estimated using Cohen’s Kappa, and the cumulative incidence of cancer-specific death was estimated at 6 years with the Aalen-Johansen estimator.ResultsConcordance between biopsy and RP pathology was 0.53 (95CI: 0.43–0.63), 0.38 (95CI: 0.29–0.48), and 0.16 (95CI: 0.11–0.21) for cBx, targeted biopsy (tBx), and sBx, respectively. For standalone sBx and RP, concordance was 0.29 (95CI: 0.27–0.32). Interrelated GG concordance between tBx and sBx was 0.67 (95CI: 0.62–0.71) in cBx. The proportion of correctly assessed GG based on RP pathology was 54% in both cBx and standalone sBx. Incidence of prostate cancer-specific death was 0% regardless of biopsy technique in GG 1, and 22% (95CI: 11–32), 30% (95CI: 15–44), and 19% (95CI: 7.0–30) in GG 5 for cBx, tBx, or sBx, respectively.ConclusionOverall, the cBx strategy demonstrates higher concordance to RP pathology than the standalone sBx. However, cBx exhibits more overgrading of the GG of RP pathology compared to sBx. Ultimately, the classic grading system does not take change in the diagnostic pathway into account, and grading should be altered accordingly to ensure appropriate treatment.

Active surveillance for low-risk prostate cancer with high tumor burden at biopsy: lessons learned from a contemporary radical prostatectomy cohort.

To investigate whether initial tumor burden at biopsy could predict adverse features after radical prostatectomy (RP) in International Society of Urological Pathology (ISUP) 1 prostate cancer (PCa) patients. This retrospective study was conducted in six referral centers. The cohort included patients with ISUP 1 PCa at systematic and MRI-targeted biopsy. We defined a high tumor burden at biopsy if ≥ 20% of cores were positive. The endpoint of the study was adverse features at RP, defined as ≥ pT3a stage and/or N1 and/or ISUP ≥ 3. Sensitivity analyses were performed to assess associations between different thresholds on biopsy (percentage of positive cores [PPC] ≥ 25%, ≥ 33%, ≥ 50%, bilateral positivity and positive cores > 3) and adverse features. As the number of targeted biopsies sampled may influence the number of positive cores, we used a virtual biopsy model in which all targeted biopsy results were interpreted as a single targeted biopsy. A total of 312 contemporary patients were included. At final pathology, 99 patients (32%) had adverse features. In multivariate logistic regression analysis, there was no statistical association between PPC > 20% and adverse features (OR = 1.22; 95%CI:0.69-2.22, p = 0.5). In sensitivity analysis, tumor burden at biopsy was not associated with the risk of adverse features, regardless of the definition used (all p > 0.05). When we considered a unique virtual targeted biopsy, tumor burden remained not associated with adverse features (all p > 0.05). ISUP 1 PCa tumor burden at biopsy did not predict adverse features in this study, suggesting that it should not be used alone as an exclusion criterion when assessing eligibility for active surveillance.

Role of Systematic Biopsy in the Era of Targeted Biopsy: A Review.

Prostate cancer (PCa) is a major public health issue, as the second most common cancer and the fifth leading cause of cancer-related deaths among men. Many PCa cases are indolent and pose minimal risk, making active surveillance a suitable management approach. However, clinically significant prostate carcinoma (csPCa) can lead to serious health issues, including progression, metastasis, and death. Differentiating between insignificant prostate cancer (inPCa) and csPCa is crucial for determining appropriate treatment. Diagnosis of PCa primarily involves trans-perineal and transrectal systematic biopsies. Systematic transrectal prostate biopsy, which typically collects 10-12 tissue samples, is a standard method, but it can miss csPCa and is associated with some complications. Recent advancements, such as magnetic resonance imaging (MRI)-targeted biopsies, have been suggested to improve risk stratification and reduce overtreatment of inPCa and undertreatment of csPCa, thereby enhancing patient quality of life and treatment outcomes. Guided biopsies are increasingly recommended for their ability to better detect high-risk cancers while reducing identification of low-risk cases. MRI-targeted biopsies, especially when used as an initial biopsy in biopsy-naïve patients and those under active surveillance, have become more common. Utilization of MRI-TB alone can decrease septic complications; however, the combining of targeted biopsies with perilesional sampling is recommended for optimal detection of csPCa. Future advancements in imaging and biopsy techniques, including AI-augmented lesion detection and robotic-assisted sampling, promise to further improve the accuracy and effectiveness of PCa detection.

A Multi-Institutional Study of Magnetic Resonance/Ultrasound Fusion-Guided Nanoparticle-Directed Focal Therapy for Prostate Ablation.

Focal therapy aims to provide a durable oncologic treatment option for men with prostate cancer (PCa), while preserving their quality of life. Most focal therapy modalities rely on the direct tissue effect, resulting in a possible nontargeted approach to ablation. Here, we report the results of the first human feasibility trial utilizing nanoparticle-directed focal photothermal ablation for PCa. A prospective, open-label, single-arm, multicenter study of men with localized PCa in Gleason Grade Group 1 to 3 was conducted. Men received a single infusion of gold nanoparticles (AuroShells), followed by magnetic resonance (MR)/ultrasound (US) fusion-guided laser excitation of the target tissue to induce photothermal ablation. MRI was used to assess the effectiveness of prostate tissue ablation at 48 to 96 hours, 3 months, and 12 months post treatment. At 3 months, a targeted fusion biopsy of the lesion(s) was conducted. At 12 months, a targeted fusion biopsy and standard templated biopsy were performed. Treatment success was determined based on a negative MR/US fusion biopsy outcome within the treated area. Forty-six men were enrolled in the study, and 44 men with 45 lesions completed nanoparticle infusion and laser treatment. The mean PSA level at baseline was 9.5 ng/mL, which decreased to 5.9 ng/mL at 3 months and to 4.7 ng/mL at 12 months (P < .0001). The oncologic success rates at 3 and 12 months resulted in 29 (66%) and 32 (73%) of 44 patients, respectively, being successfully treated, confirmed with negative MR/US fusion biopsies within the ablation zone. Among Gleason Grade Group, maximum lesion diameter on MRI, prostate volume, and Prostate Imaging Reporting and Data System scoring, the maximum lesion diameter was significantly associated with the odds of treatment failure at 12 months (P = .046). Nanoparticle-directed focal laser ablation of neoplastic prostate tissue resulted in 73% of patients with successful treatment at 12 months post treatment, confirmed by negative MR/US fusion biopsy of the treated lesion and a systematic biopsy. 02680535.

Prediction of high-risk prostate cancer based on the habitat features of biparametric magnetic resonance and the omics features of contrast-enhanced ultrasound

Rationale and objectivesTo predict high-risk prostate cancer (PCa) by combining the habitat features of biparametric magnetic resonance imaging (bp-MRI) with the omics features of contrast-enhanced ultrasound (CEUS). Materials and methodsThis study retrospectively collected patients with PCa confirmed by histopathology from January 2020 to June 2023. All patients underwent bp-MRI and CEUS of the prostate, followed by a targeted and transrectal systematic prostate biopsy. The cases were divided into the intermediate-low-risk group (Gleason score ≤7, n = 59) and high-risk group (Gleason score ≥8, n = 33). Radiomics prediction models, namely, MRI_habitat, CEUS_intra, and MRI-CEUS models, were developed based on the habitat features of bp-MRI, the omics features of CEUS, and a merge of features of the two, respectively. Predicted probabilities, called radscores, were then obtained. Clinical-radiological indicators were screened to construct clinic models, which generated clinic scores. The omics–clinic model was constructed by combining the radscore of MRI-CEUS and the clinic score. The predictive performance of all the models was evaluated using the receiver operating characteristic curve. ResultsThe area under the curve (AUC) values of the MRI-CEUS model were 0.875 and 0.842 in the training set and test set, respectively, which were higher than those of the MR_habitat (training set: 0.846, test set: 0.813), CEUS_intra (training set: 0.801, test set: 0.743), and clinic models (training set: 0.722, test set: 0.611). The omics–clinic model achieved a higher AUC (train set: 0.986, test set: 0.898). ConclusionsThe combination of the habitat features of bp-MRI and the omics features of CEUS can help predict high-risk PCa.

Organized prostate cancer screening program: a proposal from the Italian Society of Urology (SIU).

To contrast opportunistic PCa screening, the European Union Council suggested extending screening programs to PCa by recommending the implementation of a stepwise approach in the EU Countries to evaluate the feasibility and effectiveness of an organized program based on PSA testing in combination with additional MRI as a follow-up test. The objective of this expert-based document is to propose an organized PCa screening program according to the EU Council recommendations. The Italian Society of Urology (SIU) developed a team of experts with the aim to report 1) the most recent epidemiologic data about incidence, prevalence, and mortality of PCa; 2) the most important risk factors to identify categories of men with an increased risk to eventually develop the disease; 3) the most relevant studies presenting data on population-based screening; and 4) the current recommendations of the leading International Guidelines. According to previous evidence, the Panel proposed some indications to develop a new organized PCa screening program for asymptomatic men with a life-expectancy of at least fifteen years. The SIU Panel strongly supports the implementation of a pilot, organized PCa screening program inviting asymptomatic men in the age range of 50-55 years. Invited men who are already performing opportunistic screening will be randomized to continue opportunistic screening or to cross into the organized protocol. Men with PSA level ≤3 ng/mL and familiarity for PCa received a DRE as well as all those with PSA levels >3 ng/mL. All other men with PSA levels greater than 3 ng/mL proceed to secondary testing represented by mpMRI. Men with Prostate Imaging-Reporting and Data System (PI-RADS) lesions 3 and PSAD 0.15 ng/mL/cc or higher as well as those with PI-RADS 4-5 lesions proceed to targeted plus systematic prostate biopsy. The primary outcome of the proposed pilot PCa screening program will be the detection rate of clinically significant PCa defined as a tumor with a ISUP Grade Group ≥2. Main secondary outcomes will be the detection rate of aggressive PCa (ISUP Grade Group ≥4); the detection rate of insignificant PCa (ISUP Grade Group 1); the number of unnecessary prostate biopsy avoided, the metastasis-free survival, and the overall survival. Men will be invited over a one-year period. Preliminary analyses will be planned 2 and 5 years after the baseline enrollment. According to the recent EU Council recommendations on cancer screening, pilot studies evaluating the feasibility and effectiveness of PCa screening programs using PSA as the primary and mpMRI as the secondary screening test in selected cohorts of patients must be strongly promoted by scientific societies and supported by national governments.

Bimodal imaging:Detection rate of clinically significant prostate cancer is higher in MRI lesions visible to transrectal ultrasound.

To explore the detection rates of clinically significant prostate cancer (csPCa; ISUP ≥2) in patients with a single MRI lesion that is visible or invisible on transrectal ultrasound (TRUS) during biopsy. Retrospective analyses of patients who underwent targeted and systematic biopsy of the prostate for one MRI-visible lesion (PI-RADS score ≥ 3) between 2017 and 2022. TRUS-visibility, PI-RADS score, and clinical parameters were recorded prospectively. Univariable and multivariable logistic regression models were used to identify predictors of csPCa. 277 consecutive patients with one MRI-visible lesion were identified. A correlating lesion on TRUS was present in 147/277 (53%). The median age, PSA level, and prostate volume were 68.0 years (IQR: 62.0-73.0), 7.3 ng/ml (IQR: 5.4-10.8) and 45.0 cc (IQR: 32.0-68.0), respectively. Baseline parameters were not significantly different between the two groups. CsPCa was detected in 59/130 (45%) without and in 102/147 (69%) patients with a corresponding TRUS lesion. In multivariable logistic regression analysis predicting csPCa, TRUS-visibility (OR: 2.13, CI: 1.14-4.03, p = 0.02) and PI-RADS score (PI-RADS 4: OR: 7.28, CI: 3.33-17.19; PI-RADS 5: OR: 13.39, CI: 5.27-36.83, p < 0.001) achieved independent predictor status. Bimodal-visible lesions more often harbored csPCa and were easier to target. TRUS-visibility of MRI lesions is an independent predictor of csPCa. Therefore, education in both modalities is essential. Despite MRI, the ultrasound should still be diligently examined.

Image-guided multiparametric magnetic resonance imaging-transrectal ultrasound fusion biopsy augmented with a sextant versus an extended template random biopsy: Comparison of cancer detection rates, complication and functional outcomes.

To compare the efficacy of a novel fusion template "reduced six-core systemic template and multiparametric magnetic resonance imaging/transrectal ultrasound (mpMRI/TRUS) fusion targeted biopsy" (TBx+6c), with mpMRI/TRUS fusion-targeted biopsy and 12-core systematic biopsy template (TBx+12c) in the diagnosis of prostate cancer (PCa). This is an institutional review board approved single-center observational study involving adult men undergoing fusion-targeted biopsies for the diagnosis of PCa. Patients were sorted into cohorts of TBx+6c or TBx+12c based on the systematic biopsy template used. The study's main objective was to determine the cancer detection rate (CDR) for overall PCa and clinically significant PCa (csPCa) and the secondary objectives were to compare complication rates and functional outcome differences between the cohort. A total of 204 patients met study's inclusion criteria. TBx+6c group had 120 patients, while TBx+12c cohort had 84 patients. The groups had similar baseline characteristics and overall CDR in the TBx+6c cohort was 71.7% versus 79.8%, compared to the TBx+12c (p = 0.18) whereas, the csPCa detection rate in the TBx+6c group was 50.8% versus 54.8% in the TBx+12c group (p = 0.5). TBx+6c cohort had lower overall complication rate of 3% versus 13%, (p = 0.01) and ≥ grade 2 complication rates (1 (1%) vs. 3(4%), p = 0.03) compared to the TBx+12c cohort. There were no differences in IIEF-5 (p = 0.5) or IPSS (p = 0.1) scores at baseline and 2-weeks and 6-weeks post-biopsy. TBx+6c cohort, when compared to the TBx+12c cohort, demonstrated comparable diagnostic performance along with similar functional outcomes and lower complication rates. These results suggest the importance of further exploring the clinical implications of adopting a TBx+6c schema for PCa diagnosis in comparison to the widely used TBx+12c schema through a multicenter randomized controlled trial.

PE012 Can we rely solely on MRI/targeted biopsies and excluding systematic biopsies preoperatively in radical prostatectomy?

PE012 Can we rely solely on MRI/targeted biopsies and excluding systematic biopsies preoperatively in radical prostatectomy?

Lesion size may affect diagnostic capabilities of MRI-guided ultrasound fusion biopsy and cognitive targeted biopsy for clinically significant prostate cancer

MRI-guided targeted biopsy (MRGB) was recommended as part of biopsy paradigm of prostate cancers by current guidelines. This study aimed to analyze the diagnostic efficacy of MRGB and systemic biopsy (SB), and to compare diagnostic capabilities within subgroups of MRGB: MRI-cognitive biopsy (MRCB) and MRI-fusion biopsy (MRFB). We retrospectively enrolled patients who underwent MRGB for suspicious malignant lesion(s) identified on MRI in a single tertiary center, sample size was 74 patients. An mpMRI was performed prior to biopsy and reviewed by an experienced radiologist specialized in prostate cancer. Per-person results of MRGB and each concomitant SB were analyzed as independent biopsies for its positive biopsy rate and positive core percentage. Per-lesion results of MRFB and MRCB were compared for the detection rate. Variables of interest were analyzed with t-test, chi-squared test, and logistic regression analysis. Statistical analyses were performed with IBM Statistical Product and Service Solutions (SPSS), Version 23 (IBM, Armonk, New York). Total of 74 patients fulfilled the inclusion criteria and were enrolled. MRFB had higher PCa detection rate comparing to both MRCB and SB (56.1%, 30.3%, and 33.9% respectively, p value = 0.036); clinically significant prostate cancer (csPCa) detection rate was also significantly higher in MRFB group (43.9%, 24.2%, and 16.9% in each group respectively, p value = 0.011). In per-lesion analysis, MRCB and MRFB had no significant difference in PCa and csPCa detection rate (41.0% vs. 26.2% and 29.5% vs. 16.7% respectively, p value = 0.090 and 0.103). In the lesion ≦ 1.3 cm group, MRFB could achieve higher PCa detection rate, comparing to MRCB (36.4% vs. 14.3%, p value = 0.047); there were also higher positive rates for PCa and csPCa per biopsied cores (22.1% vs. 6.8% and 15.6% vs. 2.7%, p value = 0.029 and 0.028, respectively). Further logistic regression of multi-variate analysis in subgroup of lesion ≦ 1.3 cm revealed that PIRADS score and biopsy method were significant predictors of positive biopsy result for PCa (p value = 0.045 and 0.026, respectively) and for csPCa (p value = 0.043 and 0.025, respectively). In patients receiving trans-perineal prostate biopsy, MRFB had higher cancer detection rate than MRCB and SB. In per lesion comparison, MRFB and MRCB had similar diagnostic accuracy. However, in lesions with diameter less than 1.3 cm, MRFB can provided better diagnose value for PCa and csPCa than MRCB.