Prostate-specific membrane antigen positron emission tomography is increasingly used in the evaluation of suspected prostate cancer, but radiotracer activity may occur in benign or congenital conditions and lead to false-positive interpretation. Although urinary tracer activity is often considered in patients with prior prostate or urinary tract surgery, congenital genitourinary anomalies can produce a similar imaging pitfall in patients without previous surgical intervention. We describe a seventy-three-year-old man with an elevated prostate-specific antigen level, no history of prior prostate or urinary tract surgery, and an indeterminate lesion on prostate magnetic resonance imaging who demonstrated focal tracer activity near the right seminal vesicle on prostate-specific membrane antigen positron emission tomographic imaging. Additional post-void imaging showed radiotracer accumulation within the right seminal vesicle region, and correlation with magnetic resonance imaging suggested reflux of urine into a cystic seminal vesicle remnant containing a small calculus. Further assessment revealed absence of the right kidney, consistent with a congenital renal tract anomaly linking the seminal vesicle abnormality and urinary reflux. Biopsy demonstrated benign prostatic tissue, confirming reflux of urine rather than malignancy as the cause of radiotracer uptake. This case highlights a rare interpretative pitfall in a patient without prior prostate surgery and emphasises that awareness of congenital anomalies involving the seminal vesicles can improve diagnostic confidence and reduce unnecessary biopsy in future cases.

BACKGROUND:MRI is recommended for men with clinical suspicion of significant prostate cancer. Those with high clinical risk but non-suspicious or equivocal MRI often undergo prostate biopsy, but have a low likelihood of clinically significant prostate cancer, and a high incidence of clinically insignificant prostate cancer. We aimed to investigate whether gallium-68 ([68Ga]Ga)-prostate-specific membrane antigen (PSMA)-11 PET-CT could reduce the number of people requiring prostate biopsy and limit biopsy to targeted cores, without compromising clinically significant prostate cancer diagnosis. METHODS:In this multicentre, non-inferiority, phase 3, randomised controlled trial, done at at seven Australian hospitals, we recruited biopsy-naive participants with clinical suspicion of significant prostate cancer, equivocal (Prostate Imaging-Reporting and Data System [PI-RADS] 3) or non-suspicious (PI-RADS 2) MRI but high clinical risk (eg, prostate-specific antigen [PSA] density of >0·1 ng/mL/mL, strong family history of prostate cancer, abnormal digital rectal examination, BRCA mutation, PSA >10 ng/mL, PSA doubling time <36 months, or PSA velocity >0·75 ng/mL per year), PSA of 20 ng/mL or less, and clinical T2 disease or less. Participants were randomly assigned (1:1) using a centralised web-based system to undergo [68Ga]Ga-PSMA-11 PET-CT (experimental group) or systematic transperineal prostate biopsy (control group), using block sizes of two or four and stratification by study site. There was no masking for participants or investigators. Participants with positive [68Ga]Ga-PSMA-11 PET-CT (PRIMARY score 3-5) underwent PSMA-PET-targeted transperineal prostate biopsies, whereas those with a negative result (PRIMARY score 1-2) avoided biopsy. The co-primary outcomes were the proportion of participants with clinically significant prostate cancer, defined as a Gleason score of 3 + 4 (≥10% pattern 4) or higher, and the proportion of participants in the [68Ga]Ga-PSMA-11 PET-CT group who avoided biopsy within 6 months of random assignment. A two-sided 95% Wald CI based on a binomial model was used to estimate the risk difference in the proportion of participants with clinically significant prostate cancer (non-inferiority margin 10%) and to estimate the proportion of participants in the experimental group who had avoided biopsy 6 months after random assignment (20% threshold), analysed based on intention to treat. This trial is registered with ClinicalTrials.gov, NCT05154162, and participant follow-up is ongoing. FINDINGS:Between March 2, 2022, and Aug 24, 2025, 660 eligible male participants were enrolled and had a median age of 61 years (IQR 56-66), a median PSA of 5·2 ng/mL (4·0-7·0), and a median PSA density of 0·13 ng/mL/mL (0·09-0·17). There were PI-RADS 2 in 335 (51%) participants and PI-RADS 3 in 325 (49%) participants. Ethnicity data were not collected. 329 (50%) were assigned to the control group with systematic transperineal prostate biopsy, and 331 (50%) were assigned to the experimental group with [68Ga]Ga-PSMA-11 PET-CT. The proportion of participants with clinically significant prostate cancer in the experimental group (39 [12%] of 331) was non-inferior to the control (51 [16%] of 329; difference -3·7% [95% CI -8·9 to 1·5%]; p=0·0093). Use of [68Ga]Ga-PSMA-11 PET-CT avoided biopsy in 163 (49%) of 331 participants (95% CI 44 to 55%; p <0·0001). After prostate biopsy, participants reported similar proportions of pain (33 [21%] in the experimental group vs 62 [21%] in the control group), haematuria (60 [38%] vs 126 [43%]), and haematospermia (77 [48%] vs 133 [45%]). INTERPRETATION:[68Ga]Ga-PSMA-11 PET-CT could have the potential to improve the diagnostic pathway of patients with a high clinical risk but non-suspicious or equivocal prostate MRI. Further research, including health-economic analyses and validation with other PSMA radiopharmaceuticals, are needed to confirm the clinical implementation and generalisability of this approach. FUNDING:Prostate Cancer Foundation, National Health and Medical Research Council, St Vincent's Curran Foundation, and Peter MacCallum Cancer Foundation.

This interim analysis of a multicentre implementation trial (n = 200) evaluated a multimodal artificial intelligence biomarker's impact on shared short-term androgen deprivation therapy (ST-ADT) decisions in intermediate-risk prostate cancer (IR-PC). Biomarker testing altered 27.5% (CI: 21.4-34.2%) of final decisions. ST-ADT use significantly decreased: 70.3% (CI: 58.5-80.3%) of patients initially electing ST-ADT changed to 'NO', versus a 2.4% (CI: 0.5-6.8%) shift to 'YES' (p < 0.001). Decision changes were significantly greater in unfavourable versus favourable IR-PC (35% v 4%; p < 0.001). These interim findings demonstrate a significant shift toward de-escalation.

OBJECTIVE:To provide a comprehensive review, analysis and critique of guidelines from various oncological and urological organisations regarding the use pelvic lymph node dissection (PLND) in men undergoing radical prostatectomy (RP) for primary treatment of prostate cancer (PCa). METHODS:PubMed, Google Scholar and the official webpages of major urological and oncological societies were searched for PCa guidelines. Guidelines were assessed for recommendations and opinions regarding the use of PLND. A total of 15 guidelines were identified and included for this review. RESULTS:There is consensus amongst guidelines that an extended template (ePLND), is the preferred templated when PLND is to be undertaken. The majority of guidelines acknowledge the lack of proven oncological benefit from PLND, and that the largest benefit is from improved staging information. However, there is significant divergence between the guidelines about which patients should undergo PLND. Some guidelines advocate for the abandonment of PLND altogether, whilst others adopt a risk-stratified approach, suggesting that patients should be offered PLND based on nomograms or clinical risk stratification. CONCLUSION:Whilst ePLND is recommended by some guidelines for select patients undergoing RP, it remains a contentious topic with significant discordance between guidelines regarding patient selection. Given the lack of proven oncological benefit and significant morbidity from the procedure, careful selection is required. It is uncertain as to how pathological findings on PLND will change management given recent trends towards salvage rather than adjuvant radiotherapy, and improved preoperative staging with prostate-specific membrane antigen-positron emission tomography/computed tomography.

Prostate biopsy prior to radical treatment for prostate cancer is a common practice worldwide to allow diagnosis, prognostication, and treatment planning. However, recent advances in prostate multiparametric magnetic resonance imaging (mpMRI) and prostate-specific membrane antigen (PSMA)-positron emission tomography (PET) have made the possibility of a “biopsy-free” radical prostatectomy, without prior biopsy, closer to reality than before. The biopsy-free approach serves to avoid investigation-related morbidity, health care resources, and time to definitive treatment, but is not without risk. Here we review the literature surrounding the rationale, limitations, and current data.

OBJECTIVE:To assess the efficacy of prostate artery embolisation (PAE) in the management of obstructive benign prostatic hyperplasia (BPH) by conducting formal urodynamic studies. METHODS:Patients with symptomatic BPH underwent baseline assessments, including urodynamic evaluation, followed by PAE. Follow-up International Prostate Symptom Scores (IPSS), Quality of Life questionnaire (QoL) scores, prostate volume and urodynamic variables were assessed at a mean follow-up of 18 months. RESULTS:A total of 105 patients underwent PAE, with average final follow-up at 18 months. Prostate volumes reduced by a mean of 30.6% and significant improvements were identified across all IPSS parameters (total IPPS decreased by 55%; P < 0.001), QoL scores (improved by 65.9%; P < 0.001), maximum urinary flow rate (increased by 5 mL/s; P < 0.001), postvoid residual urine volume (decreased by 24%; P = 0.049), detrusor pressure (decreased from 65.0 to 48.9 cmH2O; P < 0.001) and bladder obstruction rates. Bladder obstruction decreased from 66.7% to 29.8% of patients following embolisation. Results were found to be positively correlated to the absolute amount of embolic material injected during the embolisation procedure. PAE was well tolerated, with expected post-embolisation symptoms resolving completely after a mean (sd; range) of 7 (±5; 1-28) days. There were no major procedural complications, no reported urinary incontinence, and new retrograde ejaculation occurred in 2%. CONCLUSION:In this study, PAE resulted in statistically significant improvements by both subjective and objective measures, including symptom severity, quality of life and urodynamic parameters. Whilst longer-term studies are required, these findings support PAE as a non-surgical option within the treatment algorithm for managing symptomatic, obstructive BPH.

BACKGROUND AND OBJECTIVE:Evidence suggests that curative treatment for low-risk prostate cancer (LRPC) has no survival benefits over active surveillance (AS); thus, treatment choice becomes a value-sensitive decision. Decision aids (DAs) have the potential to facilitate this process, yet no DA has been tailored to the Australian health care system or population. This study aims to evaluate the impact of an online DA (Navigate) on the uptake of AS, quality of life, and decision-making in Australia. METHODS:This parallel-group, prospective, randomised controlled trial recruited men (from May 2017 to May 2021) from participating cancer centres, via self-referral, or via clinician referral. The inclusion criteria were the following: a recent LRPC diagnosis, no decision on treatment, and clinical suitability for AS. Partners could also enrol. Assessments were undertaken at baseline (before decision) and after baseline (1, 2, and 6 mo). Participants were randomised 1:1 to Navigate (online DA, intervention) or a national prostate cancer website (usual care), stratified by the site/recruitment method. Partners were allocated to the group matching their respective partners. The primary outcome was self-reported uptake of AS for first-line treatment at 1 mo. The secondary outcomes included decision-making preparedness; decisional conflict, regret, and satisfaction; illness communication; and prostate cancer-specific quality of life. Intention-to-treat analyses were conducted. KEY FINDINGS AND LIMITATIONS:Of the 619 patients referred, those eligible (n = 302) were randomised to either Navigate (n = 153) or usual care (n = 149), with no significant between-group differences at baseline. The proportion of men self-reporting AS versus another treatment was 90.6% (Navigate) versus 79.0% (usual care; p = 0.008). Navigate participants also reported greater decision-making preparedness (p < 0.001). Partners were allocated to Navigate (n = 70) or usual care (n = 49); no significant between-group differences were found. Longer-term outcomes were not measured. CONCLUSIONS AND CLINICAL IMPLICATIONS:Providing men with an online DA resulted in higher uptake of AS for LRPC than standard resources and in increased decision-making preparedness. By increasing the uptake of AS, DAs may help reduce treatment-related morbidity. Implementation research assessing the possibility of integrating Navigate into standard care is needed.

The ProsD trial aimed to determine if oral vitamin D supplementation could prevent prostate cancer (PC) progression in men on active surveillance (AS). ProsD is a phase-II double-blinded randomized trial of newly diagnosed, low-intermediate risk PC cases, aged between 50 and 80 years and on AS. The intervention was a monthly oral dose of cholecalciferol (50,000IU; Vitamin D) or placebo. Primary and secondary endpoints were active therapy-free (ATFS) and progression-free (PFS) survival, respectively. Blood samples were analysed for vitamin D metabolites and cytokinesis-block micronucleus cytome (CBMN) markers for lymphocytic genome damage. There were 123 randomised participants (81 vitamin D and 42 placebo) included in this analysis. Mean (SD) for age was 66.5 (6.6) years and for 25(OH)D levels were 72.0 (19.9) and 66.4 (18.4) nmol/L at baseline (p = 0.1), and 91.9 (19.9) and 60.4 (24.4) nmol/L at 24 months, in the vitamin D and placebo arms respectively. There were no appreciable differences in ATFS (plog-rank = 0.44), PFS (p plog-rank = 0.60) and occurrence of adverse events, in each trial arm. There were declines in some of the lymphocytic CBMN markers in the vitamin D arm. Vitamin D supplementation did not prevent PC progression, although reduced prevalence of CBMN markers may indicate a benefit of vitamin D supplementation. Australia New Zealand Clinical Trials Registry (ACTRN12616001707459).

Background and objective: Evidence on the cost effectiveness of decision aids to guide management decisions for men with prostate cancer is limited. We examined the cost utility of the Navigate online decision aid for men with prostate cancer in comparison to usual care (no decision aid). Methods: A Markov model with a 10-yr time horizon was constructed from a government health care perspective. Data from the Navigate trial (n = 302) and relevant published studies were used for model inputs. Incremental costs and quality-adjusted life-years (QALYs) were calculated for the two strategies. One-way and probabilistic sensitivity analyses were undertaken to address model uncertainty. Key findings and limitations: On average, the Navigate strategy was estimated to cost AU$8899 (95% uncertainty interval [UI] AU$7509-AU$10 438) and produce 7.08 QALYs (95% UI 6.73-7.36) in comparison to AU$9559 (95% UI AU$8177-AU$11 017) and 7.03 QALYs (95% UI 6.67-7.31) or usual care. The Navigate strategy dominated usual care as it produced cost-savings and higher QALYs, although differences for both outcomes were small over 10 yr. The likelihood of Navigate being cost effective at a conventionally acceptable threshold of AU$50 000 per QALY gained was 99.7%. This study is limited by the availability, quality, and choice of the data used in the model. Conclusions and clinical implications: Use of an online decision aid for men with pros-tate cancer appears to be cost effective relative to usual care in Australia, driven by the higher acceptance and uptake of active surveillance. Wider implementation of deci-sion aids may better inform men diagnosed with prostate cancer about their manage-ment options. Patient summary: We looked at the cost effectiveness of an online decision aid for guid-ing Australian men with prostate cancer in choosing a management option. We found that this decision aid was cost effective, mainly because more men chose active surveil-lance. Decision aids that inform patients about their management options should be more widely used in health care. (c) 2024 European Association of Urology. Published by Elsevier B.V. All rights are reserved, including those for text and data mining, AI training, and similar technologies.

Background:Focal irreversible electroporation (IRE) has shown promising initial oncological and functional outcomes in the treatment of localised prostate cancer (PCa), although robust evidence to support its efficacy and optimal utilisation is still maturing. We aim to summarise the oncological outcomes, functional outcomes, and safety profile of IRE for the treatment of localised PCa. Methods:A search was performed across four electronic databases: MEDLINE, Embase, Web of Science, and Cochrane Database of Systematic Reviews; 620 articles were screened after removal of duplicates; 73 full-texts were reviewed. Results:Thirty-one articles representing 29 studies were included. Focal IRE patients ranged from 10 to 411 patients. Median follow-up ranged from 6 to 60 months. Three studies reported exclusively on salvage-IRE, and three reported on both primary- and salvage-IRE. A combination of all risk-groups was included. Safety margins ranged from 0 to 10 mm. Early post-IRE imaging within 1 month of treatment was performed in 14 studies. Post-treatment biopsy was performed in 23 studies, ranging from 6 to 18 months after IRE. In-field recurrence rates ranged from 0-33% and 0-10% in the primary and salvage settings respectively. Out-of-field recurrence rates ranged from 0-33% and 0-14% respectively. Retreatment rates ranged from 0-37% in the primary setting and 0-24% in the salvage setting. In the primary setting, four studies reported a decrease in pad-free rates, ranging from 1-2%, while six of twelve studies noted improvements in urinary patient-reported outcome measures (PROMs). Baseline erections sufficient for intercourse declined in 10 studies, ranging from 3-22%, and deterioration in sexual function PROMs was reported in eight of 13 studies. In the salvage setting, pad-free rates decreased by 4-33% across three studies, and potency rates declined by 14-22% in four studies. Clavien-Dindo III events occurred in 1-19% of patients across six studies, and two cases of rectourethral fistula were reported. Conclusions:Oncological outcomes, although still maturing, appear promising. Functional outcomes compare favourably against whole-gland treatment, particularly in the primary treatment setting. Focal IRE appears to have a role in salvage treatment. Comparative studies are needed to evaluate its role amongst the growing array of treatments for localised PCa.

OBJECTIVES:To estimate the cost effectiveness of local anaesthetic (LA) transperineal prostate biopsy (TPB) compared to general anaesthetic (GA) TPB, considering both hospital/health system and societal perspectives. PATIENTS AND METHODS:Individual-patient data from a prospective pilot study of 80 patients who underwent LA (n = 40) or GA (n = 40) TPB according to patient preference was used. A cost-effectiveness analysis was conducted using a decision tree model considering cancer detection rates, perioperative and return to work considerations between LA and GA TPB. The economic model included costs associated with consumables, device (capital, maintenance) and personnel for each approach. Cost-effectiveness was evaluated in terms of the incremental cost/quality-adjusted life-years (QALYs) and incremental net monetary benefit. Probabilistic and one-way sensitivity analyses were performed. RESULTS:Clinical parameters were generally similar between groups, including overall (55%) and significant (35% vs 23%; P = 0.32) cancer detection and procedure-specific duration (20 vs 21 min; P = 0.53). Total procedure and recovery durations were longer in the GA group by 8 min (P < 0.001) and 32.5 min (P < 0.001), respectively. Participants in the LA group returned to work earlier than the GA group (2 vs 4 days; P = 0.046). There was a marginal gain in QALYs between the LA and GA groups (0.82385 vs 0.82383), but LA TPB had lower costs (Australian dollars [AU$]715.80 vs AU$1673.58), with an estimated average cost savings of ~AU$959. From the societal perspective, driven by the reduction in productivity loss, the average cost savings with LA TPB were ~AU$1639. Sensitivity analyses showed the probability of LA being cost effective was 100%, while utilisation of operating theatre for GA TPB was the main driver of cost difference. CONCLUSION:Performing TPB via the LA approach would be cost-saving from both hospital and societal perspectives without reducing the accuracy of the biopsy.

BACKGROUND AND OBJECTIVE:The quality and reporting of prostate magnetic resonance imaging (MRI) are operator dependent, leading to variations in estimates such as positive predictive value across sites. This impacts patient counseling, risk modeling, and risk calculators. This study assessed variation in Prostate Imaging Reporting and Data System (PI-RADS) score classification and subsequent probability of grade group (GG) ≥2 + prostate cancer. METHODS:Data from the Prostate Biopsy Collaborative Group, including multiple sites in North America, Europe, and Asia Pacific, were analyzed. Patients underwent multiparametric MRI (mpMRI) of the prostate followed by prostate biopsy during the years 2010-2023. Only those with MRI-targeted biopsy and PI-RADS score ≥3 were included. The risk of being assigned PI-RADS 4 or 5 and risk of GG ≥2 disease for these scores were estimated using logistic regression. KEY FINDINGS AND LIMITATIONS:The cohort included 7325 biopsies from 7320 unique patients from 13 sites. A two-fold variation in the probability of PI-RADS 4 or 5 assignment across sites persisted even after adjustment for patient risk (heterogeneity p < 0.001 for both). There were significant differences in the absolute risk of GG ≥2 disease for PI-RADS 4 and 5 (heterogeneity p < 0.001 for both), varying between 23% and 68% and between 49% and 87%, respectively. The use of prostate biopsy as a reference standard has limitations but reflects typical usage of mpMRI in clinical practice. CONCLUSIONS AND CLINICAL IMPLICATIONS:The probability of being assigned PI-RADS 4 or 5 and subsequent detection of GG ≥2 disease varies widely between institutions. This impacts counseling, risk stratification, and clinical practice, necessitating better standardization in the performance and interpretation of mpMRI.

BACKGROUND:Accurate primary staging of renal cancer with conventional imaging is challenging. Prostate-specific membrane antigen (PSMA) positron emission tomography/computed tomography (PET/CT) may serve to improve the accuracy of renal cancer staging. OBJECTIVE:To determine clinicopathological and management differences for primary renal cancer staged with PSMA PET/CT in comparison to conventional imaging. DESIGN, SETTING, AND PARTICIPANTS:We conducted a retrospective cohort study of PSMA PET/CT scans performed for primary staging of renal cancer and incidental renal lesions at three sites in Brisbane, Australia between June 2015 and June 2020. Clinical characteristics, imaging, and histopathology were reviewed. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS:Clinicopathological and management differences according to staging modality (PSMA PET/CT, conventional imaging) were assessed. Descriptive statistics were used to report demographics and clinical parameters. Nonparametric methods were used for statistical analysis. Fisher's exact test was used for comparison of small-cell size categorical variables. RESULTS AND LIMITATIONS:From a total of 120 PSMA PET/CT scans, 61 were included (52 staging, 9 incidental) for predominantly males (74%) with a mean age of 65.1 yr (standard deviation 12.0). Most primary lesions (40/51) were clear-cell renal cell carcinoma (ccRCC; 98% PSMA-avid), eight were non-ccRCC (75% PSMA-avid), and three were non-RCC (oncocytoma; 67% PSMA-avid). PSMA PET identified a greater number of presumed metastatic lesions than conventional imaging (195 vs 160). A management change was observed for 32% of patients (20% major, 12% minor). Limitations include the retrospective design and selection bias, lack of blinding to PSMA reporting, and the use of different PSMA radiotracers. CONCLUSIONS:PSMA PET/CT detected more metastases than conventional imaging and most renal cancers were PSMA-avid, resulting in a management change for one-third of the patients. PATIENT SUMMARY:We looked at a newer type of scan called PSMA PET/CT for first staging of kidney cancer. We found that this detects more metastasis and helps in decisions on changes in treatment for some patients. This type of imaging is a useful addition to conventional scans in tricky cases and may help in better selection of suitable treatments, but more studies are required.

You have accessJournal of UrologyProstate Cancer: Detection & Screening II (PD19)1 May 2024PD19-07 VARIATION IN THE POSITIVE PREDICTIVE VALUE OF PROSTATE MRI: DATA FROM THE PROSTATE BIOPSY COLLABORATIVE GROUP Sunny Nalavenkata, Emily Vertosick, Alberto Briganti, Hashim Ahmed, David Eldred-Evans, Kathie Wong, Stephen Gordon, Christian Gratzke, Michael Liss, Kim Moretti, Peter Ka-Fung Chiu, Michael Müntener, John Yaxley, Cedric Poyet, Matthias Jahnen, Daniel Margolis, Manish Patel, Behfar Ehdaie, and Andrew Vickers Sunny NalavenkataSunny Nalavenkata , Emily VertosickEmily Vertosick , Alberto BrigantiAlberto Briganti , Hashim AhmedHashim Ahmed , David Eldred-EvansDavid Eldred-Evans , Kathie WongKathie Wong , Stephen GordonStephen Gordon , Christian GratzkeChristian Gratzke , Michael LissMichael Liss , Kim MorettiKim Moretti , Peter Ka-Fung ChiuPeter Ka-Fung Chiu , Michael MüntenerMichael Müntener , John YaxleyJohn Yaxley , Cedric PoyetCedric Poyet , Matthias JahnenMatthias Jahnen , Daniel MargolisDaniel Margolis , Manish PatelManish Patel , Behfar EhdaieBehfar Ehdaie , and Andrew VickersAndrew Vickers View All Author Informationhttps://doi.org/10.1097/01.JU.0001009448.41537.64.07AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: The diagnostic test characteristics of mpMRI, such as positive predictive value (PPV), are commonly given as single estimates. However, both mpMRI quality and reporting of the resulting images are operator dependent, suggesting that estimates such as PPV might vary between sites. This has implications in patient counseling, risk modeling and use of risk calculators. We used data from the Prostate Biopsy Collaborative Group to assess variation in the probability of being assigned different PIRADS scores and the probability of high grade cancer for a given PIRADS (PPV). METHODS: Data was collected from multiple international sites (North America, Europe, and Asia-Pacific) for patients undergoing mpMRI followed by prostate biopsy. Patients were included in this analysis if they were reported to have had an MRI-targeted biopsy and had a PIRADS score 3+. Data was analyzed to compare patient demographics, clinical practice and the variation in clinical practice. Risk of being assigned PIRADS 4 or 5, and risk of high grade disease for PIRADS 4 and 5, was estimated by logistic regression with adjustment for age, race, PSA, prostate volume, DRE result, family history and prior negative biopsy. RESULTS: The cohort includes 8147 patients from 12 participating sites. After adjustment for patient risk, we found greater than 2-fold variation in the probability of being called PIRADS 4 or 5 across sites (heterogeneity p<0.001 for both). The relative risk of high-grade cancer comparing PIRADS 4 vs 3 or 5 vs 3 did not differ across institutions (meta-analytic odds ratio 3.39, 95% CI 2.84 to 4.04, heterogeneity p=0.6 and 9.78, 95% CI 7.87 to 12.1, heterogeneity p=0.7). However, there were very large differences in absolute risk of high grade disease (that is, PPV) for both PIRADS 4 and 5 (heterogeneity p<0.001 for both). The heterogeneity between both rates of PIRADS 4 and 5 and risk of high grade disease on PIRADS 4 and 5 are presented in the Figure 1. CONCLUSIONS: The probability that a given patient would be called PIRADS 4 or 5, and the resultant probability of having high-grade disease (PPV), varies enormously between different institutions. This has immediate implications for current MRI based nomograms. Better practice standardization is urgently required for mpMRI performance and subsequent radiology interpretation. Download PPT Source of Funding: NIH Grant - 5R01CA179115-05 © 2024 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 211Issue 5SMay 2024Page: e442 Advertisement Copyright & Permissions© 2024 by American Urological Association Education and Research, Inc.Metrics Author Information Sunny Nalavenkata More articles by this author Emily Vertosick More articles by this author Alberto Briganti More articles by this author Hashim Ahmed More articles by this author David Eldred-Evans More articles by this author Kathie Wong More articles by this author Stephen Gordon More articles by this author Christian Gratzke More articles by this author Michael Liss More articles by this author Kim Moretti More articles by this author Peter Ka-Fung Chiu More articles by this author Michael Müntener More articles by this author John Yaxley More articles by this author Cedric Poyet More articles by this author Matthias Jahnen More articles by this author Daniel Margolis More articles by this author Manish Patel More articles by this author Behfar Ehdaie More articles by this author Andrew Vickers More articles by this author Expand All Advertisement PDF downloadLoading ...

ObjectivesTo construct and externally calibrate a predictive model for early biochemical recurrence (BCR) after radical prostatectomy (RP) incorporating clinical and modern imaging characteristics of the primary tumour.Patients and MethodsPatients who underwent RP following multiparametric magnetic resonance imaging, prostate biopsy and prostate‐specific membrane antigen‐positron emission tomography/computed tomography (PSMA‐PET/CT), from two centres in Australia and the Netherlands. The primary outcome was biochemical recurrence‐free survival (BRFS), where BCR was defined as a rising PSA level of ≥0.2 ng/mL or initiation of postoperative treatment per clinician discretion. Proportional hazards models to predict time to event were developed in the Australian sample using relevant pre‐ and post‐surgical parameters and primary tumour maximum standardised uptake value (SUVmax) on diagnostic PSMA‐PET/CT. Calibration was assessed in an external dataset from the Netherlands with the same inclusion criteria.ResultsData from 846 patients were used to develop the models. Tumour SUVmax was associated with worse predicted 3‐year BRFS for both pre‐ and post‐surgical models. SUVmax change from 4 to 16 lessened the predicted 3‐year BRFS from 66% to 42% for a patient aged 65 years with typical pre‐surgical parameters (PSA level 8 ng/mL, Prostate Imaging‐Reporting and Data System score 4/5 and biopsy Gleason score ≥4 + 5). Considering post‐surgical variables, a patient with the same age and PSA level but pathological stage pT3a, RP Gleason score ≥4 + 5 and negative margins, SUVmax change from 4 to 16 lessened the predicted 3‐year BRFS from 76% to 61%. Calibration on an external sample (n = 464) showed reasonable performance; however, a tendency to overestimate survival in patients with good prognostic factors was observed.ConclusionTumour SUVmax on diagnostic PSMA‐PET/CT has utility additional to commonly recognised variables for prediction of BRFS after RP.