BACKGROUND:The diagnostic performance of prostate magnetic resonance imaging (MRI) critically depends on image quality and reader expertise. The PROBASE trial is a prospective population- and prostate-specific antigen (PSA)-based prostate cancer (PCa) screening study enrolling men aged 45 yr. OBJECTIVE:In this predefined substudy, we evaluated the impact of MRI quality and expert reference reading on clinically significant PCa (csPCa; International Society of Urological Pathology grade ≥2) detection. DESIGN, SETTING, AND PARTICIPANTS:This analysis included 516 participants who underwent multiparametric MRI and combined MRI-targeted biopsy and systematic biopsy after screening with PSA ≥3 ng/ml. Local Prostate Imaging Reporting and Data System (PI-RADS) scores were compared with reference readings by experienced uroradiologists. MRI quality was assessed using Prostate Imaging Quality (version 1; PI-QUAL [v1]). OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS:Detection rates, positive predictive values (PPV), and negative predictive values (NPV) were calculated at an underlying biopsy threshold of PI-RADS score of ≥4. Image quality was compared between the study sites. RESULTS AND LIMITATIONS:Reference reading yielded higher NPV (92% vs 86%), PPV (57% vs 50%), and sensitivity (83% vs 69%) than local reading. Local reading missed substantially more csPCa in PI-RADS 1-2 (17.1% vs 2.9%) and resulted in more false-positive MRI findings in PI-RADS 4-5 (n = 76 vs n = 59) than reference reading. Lower MRI quality (PI-QUAL 1-3/5) was associated with reduced csPCa detection (46% vs 62%) and true negative rate (84% vs 95%). PI-QUAL differed between the study sites. PI-RADS classification of reference reading missed small or diffusely infiltrative csPCa, often in lower quality scans. Limitations include using local interpretations to define biopsy targets, limiting retrospective comparison, and possibly underestimating reference-reader performance. CONCLUSIONS:Expert reference MRI reading substantially improves csPCa detection and can reduce unnecessary biopsies in a screening setting. High-quality imaging, standardized protocols, and experienced reading should be considered essential components of future MRI-based screening strategies. TRIAL REGISTRATION:The trial is registered with the ISRCTN (International Randomized Controlled Trial Number) registry, registration number ISRCTN37591328, and can be accessed at https://www.isrctn.com/ISRCTN37591328. The study protocol can be accessed at doi: 10.1016/j.eururo.2013.05.022.

BACKGROUND AND OBJECTIVE:To assess the effectiveness of a confirmatory prostate-specific antigen (PSA) test as a safeguard against unnecessary work-up and to improve the specificity of prostate cancer (PCa) screening. METHODS:Overall, 72,157 PSA values corresponding to screening rounds at age 45-55 yr in the PROBASE trial were analyzed. Positive PSA tests were reported as the proportion of men with an initial or confirmatory PSA ≥3 ng/ml. The cumulative PCa number over 6 yr was described for men with and without confirmatory PSA decrease at baseline screening (age 45 yr). Sankey diagrams were plotted to illustrate changes in PSA values over 10 yr with 2-yearly PSA screening. KEY FINDINGS AND LIMITATIONS:Overall, 2782 initial PSAs and 2702 (97%) confirmatory PSAs were observed. A total of 38% (95% confidence interval [CI] 36, 40) of men with initial PSA ≥3 ng/ml had a PSA <3 ng/ml at confirmatory testing. Estimates differed by age and screening round: 46% (95% CI 41, 51) in 45-yr-olds and 34% (95% CI 31, 38) in 50-yr-olds. PSA was repeated at a median of 28 d (interquartile range [IQR] 20, 39). Median change was -0.5 ng/ml (IQR -1.3, +0.06). PCa risk at 6 yr was 33% in those with confirmed PSA and 7.0% in those with PSA decrease at age 45 yr (risk ratio 4.68, CI 2.55, 8.59). The main limitation is incomplete biopsy information. CONCLUSION:PSA elevations in early-middle-aged men are common and PSA should be confirmed before initiating diagnostic work-up in a screening setting. CLINICAL IMPLICATIONS:Repeating PSA before initiating diagnostic work-up reduces immediate further diagnostics.

The optimal approach for prostate cancer (PC) screening, including the ideal starting age and most effective diagnostic method, remains under investigation. We evaluated the diagnostic performance of magnetic resonance imaging (MRI)-targeted biopsy (TBx) and systematic biopsy (SBx) in detecting clinically significant PC (csPC) in men aged 45-50 yr in PROBASE, a prospective, randomized trial of a risk-adapted screening strategy. A total of 525 participants with elevated prostate-specific antigen (≥3 ng/ml) underwent MRI followed by biopsy. Of the 209 PC cases detected, 148 (71%) were csPC. SBx identified 94% of csPC cases, while TBx detected 74% (p ≤ 0.05). SBx also diagnosed significantly more low-grade PCs than TBx (p < 0.001). These findings suggest that relying solely on MRI-TBx may lead to underdiagnosis of csPC. Combining SBx with TBx remains the most effective strategy for early detection of PC in young men undergoing screening. Future research should explore optimization strategies to reduce unnecessary biopsies while maintaining high detection rates for csPC. This trial is registered on the ISRCTN registry as ISRCTN37591328 (https://www.isrctn.com/ISRCTN37591328). The study protocol can be accessed at https://doi.org/10.1016/j.eururo.2013.05.022.

Cancer worry and risk perception are relevant psychological factors that influence preventive health behaviors. Therefore, a thorough understanding of the factors that impact their occurrence and manifestation is critical. The objective of this study was to assess prevalence and factors associated with worry about prostate cancer (PCa) and absolute/comparative risk perception in a community-based sample of 45-year-old men. Data were collected within the German PCa screening trial PROBASE. Variables were assessed by self-report questionnaires and a clinical interview. Worry about PCa and absolute/comparative risk perception were assessed each on a 5-point-Likert scale. Multivariable logistic regression was used to identify factors associated with the outcomes of interest. Data were available for 33,476 (72.0%) of 46,495 men at enrollment. 7.3% had sometimes/(very) often worry about PCa. 3.7% and 9.9% perceived their absolute risk and comparative risk as somewhat high/very high and somewhat higher/much higher, respectively. 18.8% reported a positive PCa family history. Important factors of worry about PCa, absolute risk perception, and comparative risk perception were lower urinary tract symptoms (LUTS) (OR 3.00, 95% CI 2.63-3.42; OR 2.09, CI 1.71-2.56; OR 2.41, CI 2.10-2.76) and a positive PCa family history (OR 2.35, CI 2.08-2.65; OR 15.13, CI 12.73-17.97; OR 9.69, CI 8.76-10.72). A positive history of urological (OR 3.85, CI 2.63-5.63) and non-urological cancers (OR 1.97, CI 1.52-2.54) were associated with a higher comparative risk perception. In conclusion, worry about PCa and risk perception are influenced by non-cancer-related symptoms as well as by a positive PCa family history. These findings need to be addressed in risk communication with patients.

In general, low-risk and favorable intermediate-risk prostate cancers (PCs; International Society of Urological Pathology grade group [GG] 1 and GG 2) are slow-growing cancers with low metastatic potential. Active surveillance is recommended for GG 1 PC and can be recommended for GG 2 PC in the absence of adverse pathological parameters. Therefore, the question arises as to when low-grade PC should be detected in a screening setting. We conducted an analysis of the group with intermediate prostate-specific antigen (PSA) risk (1.5-2.99 ng/ml) from the PROBASE screening trial for young men (starting age 45 yr) and evaluated 159 biopsies performed for confirmed PSA ≥3 ng/ml in the first two biennial screening rounds. Of these biopsies, 37% were positive, with 78% (46/59) showing GG 1 or GG 2 disease. Only 0.8% of men with intermediate risk (13 of 1661 men screened) had GG 3-5 PC and would have experienced a delay in diagnosis of between 1 and 3 yr if screening were performed at 5-yr intervals. These results suggest that the screening interval could be extended from 2 yr to 5 yr for men aged 45 yr at intermediate risk, similar to the interval for men at low risk (PSA <1.5 ng/ml). This would reduce unnecessary testing and overdiagnosis in nearly 10% of the screening population aged 45 yr.

BACKGROUND AND OBJECTIVE:While magnetic resonance imaging (MRI)-guided targeted biopsy (TBx) is becoming an integral part of early detection of prostate cancer (PC), its role in screening of younger men remains unclear. We analyzed the additional value of systematic biopsy (SBx) in improving detection of clinically significant PC (csPC). METHODS:A total of 525 men aged 45-54 yr with confirmed prostate-specific antigen ≥3.0 ng/ml underwent multiparametric MRI followed by combined TBx and SBx between February 2014 and August 2023 within a multicenter prospective screening trial in Germany. Software-based MRI/ultrasound fusion TBx (2 cores per lesion) combined with SBx was performed via a transrectal or transperineal approach. The primary objective was to analyze differences in csPC detection rates between SBx and TBx in relation to MRI. Secondary objectives were detection rates by International Society of Urological Pathology grade group (GG) and the distribution of SBx and/or TBx findings. KEY FINDINGS AND LIMITATIONS:PC was detected in 209 men (39%), of which 148/209 cases were csPC (71%; GG ≥2). SBx missed 24/148 csPC cases (16%) and TBx missed 49/148 (33%). SBx detected 25 more low-risk PC cases than TBx (51 vs 26). For 64% of the cases in which SBx detected higher GG than TBx (n = 89, including GG 1), the positive cores were located within MRI-detected lesions. Five GG ≥3 PC cases were not identified on MRI. Limitations include the lack of centralized MRI review before biopsy, variability in biopsy technique, retrospective subgroup analysis, and short follow-up. CONCLUSIONS AND CLINICAL IMPLICATIONS:A relevant proportion of csPC cases were missed by two-core TBx, although they were correctly identified on MRI, suggesting limitations in targeting accuracy and/or the fusion technique. SBx cores or targeted perilesional sampling, particularly in young men with smaller prostate volume, might be a valuable complement to TBx to ensure reliable and early detection of (cs)PC in this age group. PATIENT SUMMARY:We looked at the effectiveness of systematic biopsy (usually 12 cores taken from the prostate gland) and targeted biopsy (cores from a suspicious area seen on a scan) of the prostate among men aged 45-54 years as part of a prostate cancer screening trial. The results show that using only two targeted cores per lesion seen on an MRI (magnetic resonance imaging) scan may miss a significant number of clinically relevant prostate cancers. One reason could be that MRI-targeted biopsies are not always perfectly accurate. To improve diagnostic accuracy in younger men, it may be necessary to take additional systematic tissue samples, or at least more samples from around any suspicious area. This trial is registered on ISRCTN as ISRCTN37591328.

Background: Multiparametric magnetic resonance imaging (mpMRI) may allow patients with prostate cancer (PC) on active surveillance (AS) to avoid repeat prostate biopsies during monitoring. Objective: To assess the ability of mpMRI to reduce guideline-mandated biopsy and to predict grade group upgrading in patients with International Society of Urological Pathology grade group (GG) 1 or GG 2 PC using Prostate Cancer Radiological Estimation of Change in Sequential Evaluation (PRECISE) scores. The hypothesis was that the AS disqualification rate (ASDQ) rate could be reduced to 15%. Design, setting and participants: PROMM-AS was a prospective study assessing 2-yr outcomes for an mpMRI-guided AS protocol. A 12 mo after AS inclusion on the basis of MRI/transrectal ultrasound fusion-guided biopsy (FBx), all patients underwent mpMRI. For patients with stable mpMRI (PRECISE 1-3), repeat biopsy was deferred and follow-up mpMRI was scheduled for 12 mo later. Patients with mpMRI progression (PRECISE 4-5) underwent FBx. At the end of the study, follow-up FBx was indicated for all patients. Outcome measurements and statistical analysis: We calculated the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) for upgrading to GG 2 in the GG 1 group, and to GG 3 in the GG 2 group on MRI. We performed regression analyses that included clinical variables.

Background: Risk-adjusted screening for prostate cancer (PCa) aims to reduce harms byless frequent retesting, especially in men at a low risk of PCa. Definitions of low risk arebased mainly on studies in men starting screening at age 55-60 yr. Objective: To identify men at age 45 yr with a low risk of PCa. Design, setting, and participants:A population-based, risk-adjusted PCa screening trialwas conducted in Germany using baseline prostate-specific antigen (PSA) starting inyoung men (PROBASE). Intervention: PSA measurements starting at the age of 45 y Outcome measurements and statistical analysis:The incidence of PCa within 5 yr wasassessed in men with screen-negative baseline PSA <1.5 ng/ml compared with thosewith PSA 1.5- >= 3.0 ng/ml. Results and limitations:Of 23 301 men who received a first PSA test at age 45 yr, 0.79%had a screen-positive PSA value of >= ng/ml. Among the 89% of men who had a screen-negative baseline PSA value of <1.5 ng/ml, only 0.45% received a positive PSA test >= 3 ng/ml upon retesting after 5 yr. By contrast, for those with a screen-negative baseline PSAvalue of 1.5-3 ng/ml, 13% surpassed 3 ng/ml upon biennial testing within the next 4 yr.The incidence of PCa in subsequent screening rounds increased with increasing baselinePSA levels, from 0.13 per 1000 person-years for men with initial PSA level of <1.5 ng/mlto 8.0 per 1000 person-years for those with PSA levels of 1.5-3.0 ng/ml. A limitation is afollow-up time of only 5 yr, so far. Conclusions:Men with baseline PSA <1.5 ng/ml at age 45 yr are at a very low risk of PCaover the next 5 yr. Patient summary:The PROBASE study showed that men with baseline prostate-specificantigen (PSA) <1.5 ng/ml at age 45 yr have a very low prostate cancer detection rate over5 yr and do not need PSA retesting during this time.

PurposePatients with suspicion of clinically significant prostate cancer (csPC) on multiparametric prostate MRI (mpMRI) but negative or inconclusive MRI/US fusion-guided biopsy (FB) can be challenging in clinical practice. To assess the utility of MRI in-bore biopsy (IB) in patients with discordant imaging and histopathological findings after FB.MethodsConsecutive patients with Prostate Imaging Reporting and Data System (PI-RADS) category 4 or 5 on mpMRI at 3T after FB without histologically confirmed csPC who underwent IB between 01/2014 and 05/2022, were retrospectively included. The primary objective was to assess the detection rate of csPC. Secondary objectives were to analyze clinical parameters, MRI parameters, and lesion localization.ResultsIn the final cohort of 51 patients, the IB resulted in an overall detection rate of 71% for PC and 47% for csPC. Furthermore, in 55% of cases with initial low-grade PC, the Gleason score was upgraded after IB. CsPC was often detected apical and/or anterior. The detection rate for PC was 58% in PI-RADS category 4 and 94% in PI-RADS category 5 (csPC 39% and 61%, respectively). Patients with csPC had statistically significant smaller prostate volumes, a higher PI-RADS category, a higher prostate-specific antigen density (PSAD), and were older.ConclusionsFor a relevant proportion of patients with PI-RADS category 4 or 5 and negative or inconclusive findings on previous FB, but with persistent suspicion of csPC, a subsequent IB verified the presence of csPC. Therefore, IB can be a backup in cases of uncertainty.

Objectives: Diffusion weighted imaging (DWI) is the most important sequence for detection and grading prostate cancer (PCa), but it is considerably prone to artifacts. New approaches like zoomed single-shot imaging (z-EPI) with advanced image processing or multi-shot readout segmentation (rs-EPI) try to improve DWI quality. This study evaluates objective and subjective image quality (IQ) of rs-EPI and z-EPI with and without advanced processing.Materials and methods: Fifty-six consecutive patients (67 +/- 8 years; median PSA 8.3 ng/ml) with mp-MRI per -formed at 3 Tesla between February and October 2019 and subsequently verified PCa by targeted plus systematic MRI/US-fusion biopsy were included in this retrospective single center cohort study. Rs-EPI and z-EPI were prospectively acquired in every patient. Signal intensities (SI) of PCa and benign tissue in ADC, b1000, and calculated high b-value images were analyzed. Endpoints were signal-to-noise ratio (SNR), contrast-to-noise ratio (CNR), PCa contrast intensity (CI), and subjective IQ on a 5-point scale evaluated by three blinded readers. Wilcoxon signed rank test, Friedman test and Cohen's kappa coefficient was calculated.Results: SNR, CNR, and PCa CI of z-EPI with and without advanced processing was superior to rs-EPI (p < 0.01), whereas no significant differences were observed between z-EPI with and without advanced processing. Sub-jective IQ was significantly higher for z-EPI with advanced processing compared rs-EPI for ADC, b1000, and calculated high b-values (p < 0.01). Compared to z-EPI without advanced processing, z-EPI with advanced processing was superior for ADC and calculated high b-values (p < 0.01), but no significant differences were shown for b1000 images.Conclusions: Z-EPI with and without advanced processing was superior to rs-EPI regarding objective imaging parameters and z-EPI with advanced processing was superior to rs-EPI regarding subjective imaging parameters for the detection of PCa.

Background: Primary retroperitoneal lymph node dissection (RPLND) for clinical stage (CS) IIA/B seminoma without adjuvant treatment is an experimental treatment to avoid radiotherapy- or chemotherapy-related toxicity from standard treatment.Objective: The PRIMETEST trial aimed to prospectively evaluate the oncological efficacy and surgical safety of primary RPLND.Design, setting, and participants: PRIMETEST is a single-arm, single-center prospective phase 2 trial. Patients with seminoma, unilateral retroperitoneal lymph node metastases <5 cm, and human chorionic gonadotropin levels <5 mU/ml were included. Patients with CS IIA/B seminoma at initial diagnosis, and recurrence under active surveillance or following adjuvant carboplatin for CS I disease were eligible.Outcome measurements and statistical analysis: Unilateral open or robot-assisted primary RPLND was performed. The primary endpoint of the study was progression-free survival (PFS) after 36 mo. The trial was considered positive if <30% of patients experienced a recurrence.Results and limitations: Between 2016 and 2021, 33 patients were accrued (nine with primary CS IIA/B, 19 recurrences during active surveillance, and five recurrences following adjuvant carboplatin). Thirteen and 20 patients had CS IIA and IIB, respectively. Open and robot-assisted RPLND procedures were performed in 14 (42%) and 19 (58%) patients, respectively. After a median follow-up of 32 mo (interquartile range 23-46), ten recurrences were detected (30%, 95% confidence interval: 16-49%); thus, the primary endpoint was not met. Infield recurrences occurred in three of ten patients. The current analysis of risk factors could not identify the predictors of recurrence. Three of 33Conclusions: The PRIMETEST trial did not meet its primary endpoint. Nevertheless, PFS of 70% after a median follow-up of 32 mo suggests this approach to be of interest for highly selected patients. Selection criteria, however, need to be defined and validated in a larger prospective cohort of patients. Until then, surgery alone for the treatment of patients with CS IIA/B seminoma cannot be recommended outside of a clinical trial setting.Patient summary: In this study, we investigated primary surgery as an alternative to conventional treatment (chemotherapy or radiation therapy) in patients with metastatic seminoma. The primary objective of the study, to prevent at least 30% of patients from recurrence, was not met. However, certain patients may benefit from this approach and thereby avoid chemotherapy or radiation therapy. Predictive factors need to be ana & COPY; 2022 European Association of Urology. Published by Elsevier B.V. All rights reserved.

Supplemental Materials Part A: Supplementary Tables and Figures Part B: Supplementary Methods Supplementary Table S1. Clinicopathological characteristics of non-malignant and prostate cancer tissue samples used for bisulfite sequencing, Illumina 27K or 450K Infinium analysis Supplementary Table S2. GABRE expression in 9 independent PC datasets available from the ONCOMINE database Supplementary Table S3: Genes downregulated more than 0.5 fold (log2) in both PC3 and DU145 cells when overexpressing miR-224 compared to scrambled transfected cells (only genes with crosshyb_type = 1 were considered). Supplementary Table S4: Genes downregulated more than 0.5 fold (log2) in both PC3 and DU145 cells when overexpressing miR-452 compared to scrambled transfected cells (only genes with crosshyb_type = 1 were considered). Supplementary Table S5. Shortlist of potential miR-224 and miR-452 target genes Supplementary Table S6. Uni- and multivariate Cox regression analyses of biochemical recurrence-free survival in two RP cohorts. Supplementary Table S7. Uni- and multivariate Cox regression analysis of GABRE, miR-224, and miR-452 expression in relation to biochemical recurrence-free survival in the Taylor et al. RP cohort. Supplementary Table S8. Uni- and multivariate Cox regression analysis of GABRE/miR-452/miR-224 and OAZ2 (predicted miR-452 target) gene expression in relation to biochemical recurrence-free survival in the Taylor et al. RP cohort. Supplementary Figure S1. Flow charts describing sample inclusion/exclusion criteria. Supplementary Figure S2. Positive correlations between miR-224, miR-452, and GABRE expression Supplementary Figure S3. Methylation patterns of 52 CpG sites in the GABRE~miR-452~miR-224 promoter associated CpG island determined by bisulfite sequencing of prostate tissue samples from adjacent non-malignant (AN, n=7), benign prostatic hyperplasia (BPH, n=4), localized PC (LPC, n=10), and primary tumor samples from patients with metastatic PC (MPC, n=10). Supplementary Figure S4. A. Bisulfite sequencing of 52 CpG sites in the GABRE promoterassociated CpG island in three nonmalignant (PrEC, BPH1, PNT1A) and six prostate cancer cell lines (22rv1, LNCaP, VCaP, DuCaP, DU145, PC3). Supplementary Figure S5. 450K Infinium data for the GABRE~miR-224~miR-452 locus and neighboring genes at Xq28. Supplementary Figure S6. Gene-set Enrichment Analysis of "Canonical Pathways" for genes down/upregulated in DU145 or PC3 cells after miR-224 or miR-452 transfection, respectively (compared to non/scr-transfected cells and corrected for transfection-related non-specific effects). Supplementary Figure S7. Association between GABRE/MYOD1 methylation levels and clinicopathological parameters in two RP patient cohorts.

Background: Annual digital rectal examination (DRE) is recommended as a stand-alone screening test for prostate cancer (PCa) in Germany for 45+ yr olds. DRE diagnostic performance in men as young as 45 yr old has not been proved by a screening trial.Objective: To determine DRE diagnostic performance in a screening trial.Design, setting, and participants: This analysis was conducted within the multicentric, randomized PROBASE trial, which enrolled >46 000 men at age 45 to test risk-adapted prostate-specific antigen (PSA) screening for PCa.Intervention: (1) DRE was analyzed as a one-time, stand-alone screening offer at age 45 in 6537 men in one arm of the trial and (2) PCa detection by DRE was evaluated at the time of PSA-screen-driven biopsies (N = 578).Outcome measurements and statistical analysis: (1) True-/false-positive detection rates of DRE as compared with PSA screening and (2) DRE outcome at the time of a prostate biopsy were evaluated.Results and limitations: (1) A prospective analysis of 57 men with suspicious DRE at age 45 revealed three PCa. Detection rate by DRE was 0.05% (three of 6537) as compared with a four-fold higher rate by PSA screening (48 of 23 301, 0.21%). The true-positive detection rate by DRE relative to screening by PSA was 0.22 (95% confidence interval [CI] = [0.07-0.72]) and the false-positive detection rate by DRE was 2.2 (95% CI = [1.50-3.17]). (2) Among PSA-screen-detected PCa cases, 86% had unsuspicious DRE (sensitivity relative to PSA was 14%), with the majority of these tumors (86%) located in the potentially accessible zones of the prostate as seen by magnetic resonance imaging.Conclusions: The performance of stand-alone DRE to screen for PCa is poor. DRE should not be recommended as a PCa screening test in young men. Furthermore, DRE does not improve the detection of PSA-screen-detected PCa.

You have accessJournal of UrologyCME1 Apr 2023MP38-20 MRI-GUIDED ACTIVE SURVEILLANCE WITHOUT ANNUAL RE-BIOPSY IN PATIENTS WITH ISUP 1 AND 2 PROSTATE CANCER: THE PROSPECTIVE PROMM-AS STUDY Jan Philipp Radtke, Birte Valentin, Christian Arsov, Tim Ullrich, Rouvier Al-Monajjed, Matthias Boschheidgen, Markus Giessing, Cristina Lopez-Cotarelo, Gerald Antoch, and Lars Schimmöller Jan Philipp RadtkeJan Philipp Radtke More articles by this author , Birte ValentinBirte Valentin More articles by this author , Christian ArsovChristian Arsov More articles by this author , Tim UllrichTim Ullrich More articles by this author , Rouvier Al-MonajjedRouvier Al-Monajjed More articles by this author , Matthias BoschheidgenMatthias Boschheidgen More articles by this author , Markus GiessingMarkus Giessing More articles by this author , Cristina Lopez-CotareloCristina Lopez-Cotarelo More articles by this author , Gerald AntochGerald Antoch More articles by this author , and Lars SchimmöllerLars Schimmöller More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003276.20AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: There is evidence that multiparametric magnetic resonance imaging (mpMRI) may avoid repeat prostate biopsies in monitoring of patients during active surveillance (AS) for prostate cancer (PC).To assess the ability of mpMRI to risk stratify men on AS, including ISUP grade group (GG) 1 and 2 PC to reduce guideline-mandated biopsy, and to predict ISUP GG upgrading. METHODS: Prospective 2-year single-center outcome of an mpMRI-guided AS protocol (PROMM-AS). 12 months after AS inclusion with MRI/TRUS fusion-guided biopsy, all men underwent mpMRI. In case of stable mpMRI according to PRECISE criteria, re-biopsy was deferred and follow-up mpMRI after 24 months performed. In case of mpMRI progression or at the end of study, follow-up MRI/TRUS fusion-guided biopsy was indicated. Primary endpoint was a reduction of histopathological AS disqualification from previous published 25% to 15%. A sample size of in total 150 men was calculated to achieve 80% power to detect this rate difference. We calculated sensitivity, specificity, positive (PPV) and negative predictive values (NPV) for ISUP GG upgrading on MRI and performed regression analyses. RESULTS: In total, 101 men (60 with GG1 and 41 with GG2 PC) were available for analysis. Histopathological progression occurred in total in 29 men. Thus, the primary endpoint could not be reached and we performed an interim-analysis. In the GG1 subgroup 18 men had progression (30%), whereas 11 men progressed in GG2 subgroup (27%). Sensitivity, specificity, PPV and NPV for PRECISE was 94%, 64%, 81% and 88% in the GG1 subgroup and 91%, 50%, 91% and 50% in GG2 subgroup. On regression analysis, higher PRECISE scores (4-5), initial PI-RADS, PSA, age and prostate volume were significant predictors of histological progression in ISUP GG1 and higher PRECISE score, initial PI-RADS and previous negative biopsy in ISUP GG2 PC. CONCLUSIONS: MRI-guided monitoring of men on AS including PRECISE criteria avoids unnecessary follow-up biopsies in 88% of men with ISUP GG1 and sufficiently predicts GG upgrading over a follow-up period of two years in both ISUP GG1 and GG2. Source of Funding: None © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e532 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Jan Philipp Radtke More articles by this author Birte Valentin More articles by this author Christian Arsov More articles by this author Tim Ullrich More articles by this author Rouvier Al-Monajjed More articles by this author Matthias Boschheidgen More articles by this author Markus Giessing More articles by this author Cristina Lopez-Cotarelo More articles by this author Gerald Antoch More articles by this author Lars Schimmöller More articles by this author Expand All Advertisement PDF downloadLoading ...