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BACKGROUND: Active surveillance (AS) is recommended for low-risk and some intermediate-risk prostate cancer. Uptake and practice of AS vary significantly across different settings, as does the experience of surveillance-from which tests are offered, and to the levels of psychological support. OBJECTIVE: To explore the current best practice and determine the most important research priorities in AS for prostate cancer. DESIGN, SETTING, AND PARTICIPANTS: A formal consensus process was followed, with an international expert panel of purposively sampled participants across a range of health care professionals and researchers, and those with lived experience of prostate cancer. Statements regarding the practice of AS and potential research priorities spanning the patient journey from surveillance to initiating treatment were developed. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Panel members scored each statement on a Likert scale. The group median score and measure of consensus were presented to participants prior to discussion and rescoring at panel meetings. Current best practice and future research priorities were identified, agreed upon, and finally ranked by panel members. RESULTS AND LIMITATIONS: There was consensus agreement that best practice includes the use of high-quality magnetic resonance imaging (MRI), which allows digital rectal examination (DRE) to be omitted, that repeat standard biopsy can be omitted when MRI and prostate-specific antigen (PSA) kinetics are stable, and that changes in PSA or DRE should prompt MRI ± biopsy rather than immediate active treatment. The highest ranked research priority was a dynamic, risk-adjusted AS approach, reducing testing for those at the least risk of progression. Improving the tests used in surveillance, ensuring equity of access and experience across different patients and settings, and improving information and communication between and within clinicians and patients were also high priorities. Limitations include the use of a limited number of panel members for practical reasons. CONCLUSIONS: The current best practice in AS includes the use of high-quality MRI to avoid DRE and as the first assessment for changes in PSA, with omission of repeat standard biopsy when PSA and MRI are stable. Development of a robust, dynamic, risk-adapted approach to surveillance is the highest research priority in AS for prostate cancer. PATIENT SUMMARY: A diverse group of experts in active surveillance, including a broad range of health care professionals and researchers and those with lived experience of prostate cancer, agreed that best practice includes the use of high-quality magnetic resonance imaging, which can allow digital rectal examination and some biopsies to be omitted. The highest research priority in active surveillance research was identified as the development of a dynamic, risk-adjusted approach.

Active surveillance has become the preferred management strategy for patients with low risk prostate cancer, but it is unclear if active surveillance can be safely extended to favorable intermediate risk (FIR) prostate cancer patients. Furthermore, defining a favorable intermediate risk prostate cancer population safe for active surveillance remains elusive due to paucity of high-level data in this population. This article serves to review relevant data, particularly the safety of active surveillance in grade group 2 patients, and what tools are available to aid in selecting a favorable subset of intermediate risk patients.Active surveillance studies with long-term data appear to report worsened survival outcomes in intermediate risk patients when compared to those undergoing definitive treatment, but there exists a subset of intermediate risk patients with nearly equivalent outcomes to low risk patients on active surveillance. Tools such as percentage and total length of Gleason pattern 4, tumor volume, prostate specific antigen density, magnetic resonance imaging, and genomic modifiers may help to select a favorable subset of intermediate risk prostate cancer appropriate for active surveillance.Active surveillance is a viable strategy in select patients with low volume group grade 2 (GG2) prostate cancer. Prospective and retrospective data in the FIR population appear to be mostly favorable in regards to survival outcomes, but there exists some heterogeneity with respect to long-term outcomes in this patient population.

PURPOSE: Multiple studies demonstrate MRI-targeted biopsy detects more clinically significant cancer than systematic biopsy, however some clinically significant cancers are detected by systematic biopsy only. While these events are rare, we sought to perform a retrospective analysis of these cases to ascertain the reasons that MRI-targeted biopsy missed clinically significant cancer, which was subsequently detected on systematic prostate biopsy. METHODS: Patients were enrolled in a prospective study comparing cancer detection rates by transrectal MRI-targeted fusion biopsy and systematic 12-core biopsy. Patients with an elevated PSA, abnormal digital rectal exam, or imaging findings concerning for prostate cancer underwent prostate MRI and subsequent MRI-targeted and systematic biopsy in the same setting. The subset of patients with grade group (GG) ≥3 cancer found on systematic biopsy and GG≤2 cancer (or no cancer) on MRI-targeted biopsy were classified as MRI-targeted biopsy misses. A retrospective analysis of the MRI and MRI-targeted biopsy real-time screen captures determined the cause of MRI-targeted biopsy miss. Multivariable logistic regression analysis compared baseline characteristics of patients with MRI-targeted biopsy misses to GG-matched patients whose clinically significant cancer was detected by MRI-targeted biopsy. RESULTS: Over the study period of 2007 to 2019, 2103 patients met study inclusion criteria and underwent combined MRI-targeted and systematic prostate biopsies. 41 (1.9%) men were classified as MRI-targeted biopsy misses. Most MRI-targeted biopsy misses were due to errors in lesion targeting (n=21, 51.2%), followed by MRI-invisible lesions (n=17, 40.5%), and MRI lesions missed by the radiologist (n=3, 7.1%). On logistic regression analysis, lower PI-RADS score was associated with having clinically significant cancer missed on MRI-targeted biopsy. CONCLUSION: While uncommon, most MRI-targeted biopsy misses are due to errors in lesions targeting, which highlights the importance of accurate co-registration and targeting when using software-based fusion platforms. Additionally, some patients will harbor MRI-invisible lesions which are un-targetable by MRI-targeted platforms. The presence of a low PI-RADS score despite a high PSA is suggestive of harboring an MRI-invisible lesion.

Introduction:Surgical experience requires skills traditionally taught through real-time operating room education and a variety of supplemental educational strategies. Video-based coaching i...

Prostate biopsy (Bx) sampling-based diagnosis of prostate cancer (PCa) has well-described inaccuracy when compared against whole gland analysis upon prostatectomy. Although upgrading of PCa Grade Group (GG) is often described, the occurrence and prognostic implications of downgrading PCa GG at the time of radical prostatectomy (RP) is less understood. Our objective was to evaluate whether downgrading PCa GG at the time of RP was associated with future tumor behavior.The SEER database was searched from 2010 to 2017 and patients were included if they were assigned pathological grades on both Bx and RP specimen. Patients were stratified into Bx GG RP GG and Bx GG ≤ RP GG groups, and tumor behavior after treatment was examined. Cox regression was used for the survival analysis.Here, 99,835 patients were included in this study. A total of 18,516 (18.5%) patients encountered downgrading from Bx GG to RP GG. A downgrading of 1 grade occurred in 13,969 (75.4%) of these patients and of 2 or more grades occurred in 4547 (24.6%) patients. A history of higher Bx GG compared with RP GG increased the risk of cancer-specific mortality (CSM) for each given RP GG controlling for age, race, preop prostate-specific antigen level, percentage of positive biopsy cores, and pathologic TNM stages. Specifically, a history of high Bx GG conferred a 45% increased risk of CSM for any given RP GG (hazard ratio = 1.45 95% confidence interval = 1.16-1.82, p 0.001).A history of higher Bx GG, and hence downgrading at the time of RP, demonstrates some value as a risk-stratification tool for future cancer outcomes after prostatectomy.

Introduction:Annually the U.S. spends approximately $55.6 billion on malpractice and medical liability, with urology ranked 11th out of 25 specialties for number of malpractice claims. Our ...

To validate the performance of PI-RADS v2 for detection of clinically significant prostate cancer (csPca, Gleason ≥7) within the context of a new fusion biopsy program.Patients with a PI-RADS v2 assessment category assigned on pre-biopsy mpMRI between March 2015 and November 2017 were identified. Diagnostic performance of PI-RADS v2 was calculated using fusion biopsy results as reference standard using receiver operating characteristic curve analysis. Patient and lesion characteristics were analyzed with one-way ANOVA and Wilcoxon rank sum test.Of 83 patients with 175 lesions, 115/175 (65.7%) were benign, 21/175 (12%) were Gleason 6, and 39/175 (22.3%) were Gleason ≥7. csPCa rates were 0% (0/5) for PI-RADS 1, 7.4% (2/27) for PI-RADS 2, 5.8% (3/52) for PI-RADS 3, 31.2% (24/77) for PI-RADS 4, and 71.4% (10/14) for PI-RADS 5 (p 0.0001). For prediction of csPCa, patient-level AUC was 0.68 and lesion-level AUC was 0.77. Biopsy threshold of PI-RADS ≥3 was 92.6% sensitive and 22.1% specific. A threshold of PI-RADS ≥4 was 87.2% sensitive and 58.1% specific. Rate of csPca detection on concurrent standard 12 core biopsy only was 6.7%.PI-RADS v2 assessment categories assigned prior to biopsy predict pathologic outcome reasonably well in a new prostate fusion biopsy program. Biopsy threshold of PI-RADS ≥3 is highly sensitive. A threshold of ≥4 increases specificity but misses some csPCa.

Introduction Prostate cancer has traditionally been diagnosed by an elevation in PSA or abnormal exam leading to a systematic transrectal ultrasound (TRUS)-guided biopsy. This diagnostic pathway underdiagnoses clinically significant disease while over diagnosing clinically insignificant disease. In this review, we aim to provide an overview of the recent literature regarding the role of multiparametric MRI (mpMRI) in the management of prostate cancer. Materials and Methods A thorough literature review was performed using PubMed to identify articles discussing use of mpMRI of the prostate in management of prostate cancer. Conclusion The incorporation of mpMRI of the prostate addresses the shortcomings of the prostate biopsy while providing several other advantages. mpMRI allows some men to avoid an immediate biopsy and permits visualization of areas likely to harbor clinically significant cancer prior to biopsy to facilitate use of MR-targeted prostate biopsies. This allows for reduction in diagnosis of clinically insignificant disease as well as improved detection and better characterization of higher risk cancers, as well as the improved selection of patients for active surveillance. In addition, mpMRI can be used for selection and monitoring of patients for active surveillance and treatment planning during surgery and focal therapy. United States Department of Health & Human Services National Institutes of Health (NIH) - USA ; Doris Duke Charitable Foundation (DDCF) ; American Association for Dental Research ; Colgate-Palmolive Company ; Roche Holding ; Genentech

Purpose of review The present review describes the current role of metabolic imaging techniques such as multiparametric MRI (mpMRI), magnetic resonance spectroscopic imaging (MRSI), hyperpolarized MRSI, and positron emission tomography (PET) in the diagnosis of primary prostate cancer, surveillance of low-grade disease, detection of metastases, and evaluation of biochemical recurrence after therapy. Recent findings The natural history of prostate cancer ranges from indolent disease that is optimally monitored by active surveillance, to highly aggressive disease that can be lethal. Current diagnostic methods remain imperfect in noninvasively distinguishing between silent versus aggressive tumors. Hence, there is a high demand for noninvasive imaging techniques that offer insight into biological behavior of prostate cancer cells. Characterization of prostate cancer metabolism is a promising area to provide such insights. Summary Metabolic imaging may allow for greater detection and ultimately characterization of tumor based on aggressiveness and spread. Hence, it has the potential to monitor tumor activity, predict prognostic outcomes, and guide individualized therapies.

Background The use of 12-core systematic prostate biopsy is associated with diagnostic inaccuracy that contributes to both overdiagnosis and underdiagnosis of prostate cancer. Biopsies per...

While prostate multiparametric-magnetic resonance imaging (MP-MRI) has improved the diagnosis of clinically significant prostate cancer (CSPC), the complementary use of prostate-specific antigen (PSA) levels to risk-stratify for CSPC requires further study. The objective of this project was to determine if prostate MP-MRI and PSA can provide complementary insights into CSPC risk stratification.In an IRB-approved study, pathologic outcomes from patients who underwent MR/US fusion-targeted prostate biopsy were stratified by various parameters including PSA, PSA density (PSAD), age, race, and PI-RADS v2 score. CSPC was defined as a Gleason score ≥7. Logistic regression was used to determine odds ratios (OR) with 95% confidence intervals (CI). P values were reported as two-sided with p 0.05 considered statistically significant. ROC curves were generated for assessing the predictive value of tests and sensitivity + specificity optimization was performed to determine optimal testing cutoffs.A total of 327 patients with 709 lesions total were analyzed. PSAD and PI-RADS scores provided complementary predictive value for diagnosis of CSPC (AUC PSAD: 0.67, PI-RADS: 0.72, combined: 0.78, p 0.001). When controlling for PI-RADS score, age, and race, multivariate analysis showed that PSAD was independently associated with CSPC (OR 1.03 per 0.01 PSAD increase, 95% CI 1.02-105, p 0.001). The optimal cutoff of PSAD ≥ 0.1 ng/ml/cc shows that a high versus low PSAD was roughly equivalent to an increase in 1 in PI-RADS score for the presence of CSPC (4% of PI-RADS ≤3 PSAD low, 6% of PI-RADS 3 PSAD high vs. 5% of PI-RADS 4 PSAD low, 22% of PI-RADS 4 PSAD high vs. 29% of PI-RADS 5 PSAD low, 46% of PI-RADS 5 PSAD high were found to have CSPC).PSAD with a cutoff of 0.1 ng/ml/cc appears to be a useful marker that can stratify the risk of CSPC in a complementary manner to prostate MP-MRI.

Our ability to prognosticate the clinical course of patients with cancer has historically been limited to clinical, histopathological, and radiographic features. It has long been clear however, that these data alone do not adequately capture the heterogeneity and breadth of disease trajectories experienced by patients. The advent of efficient genomic sequencing has led to a revolution in cancer care as we try to understand and personalize treatment specific to patient clinico-genomic phenotypes. Within prostate cancer, emerging evidence suggests that tumor genomics (e.g., DNA, RNA, and epigenetics) can be utilized to inform clinical decision making. In addition to providing discriminatory information about prognosis, it is likely tumor genomics also hold a key in predicting response to oncologic therapies which could be used to further tailor treatment recommendations. Herein we review select literature surrounding the use of tumor genomics within the management of prostate cancer, specifically leaning toward analytically validated and clinically tested genomic biomarkers utilized in radiotherapy and/or adjunctive therapies given with radiotherapy.

TPS275 Background: It is now recognized that some patients with “oligo,” or few sites of metastases, may have the potential to completely eradicate their disease with aggressive local therapy. There are recent encouraging randomized prospective data for total consolidation of macroscopic metastases through treatment intensification involving metastasis-directed therapy (MDT). Hypotheses include that radiation to primary prostate tumor and metastatic sites affects the natural history of metastasis by virtue of radiation effects on cancer cell autonomous pathways and tumor microenvironment/normal tissue pathways. This study aims to evaluate the utility of the addition of MDT to the evolving standard of care treatment for de novo low volume metastatic prostate cancer (PCa) patients. This study will evaluate the efficacy of best systemic therapy (BST) and primary prostate radiation (XRT) versus BST, XRT and stereotactic ablative radiation therapy (SABR) MDT. Discovery correlatives associated with clinical outcome will be assessed by collection of including, but not limited to: circulating tumor cells, immunologic biomarkers, microbiota and radiomics. Methods: This study is a multi-site, non-blinded, randomized Phase II trial in patients with oligometastatic PCa. Men with de novo histologically confirmed (at any site) oligometastatic PCa (75.6 Gy to the prostate. BST will allow standard and intensified androgen blockade. The trial will evaluate the addition of SABR MDT and explore several translational and imaging correlatives. Subjects who meet eligibility criteria and qualify for enrollment will be stratified according to: (i) hormonal therapy vs intensified hormonal therapy; (ii) XRT vs XRT + primary prostate boost, and (iii) absence vs presence of bone metastasis. This study has been approved and began accrual on October 3rd, 2022, the Clinicaltrials.gov. Identifier: NCT05223803. We assume an accrual time of 24 months, with 24 months of additional follow-up time, and will randomize a total of 122 patients (61 patients in each arm). The primary endpoint with be to assess 2-year failure-free survival (FFS). Secondary endpoints will include toxicity, quality of life (QoL), time to locoregional progression, time to distant progression, time to new metastasis, radiographic progression-free survival, and duration of response. Clinical trial information: NCT05223803 .

329 Background: In 2005, the International Society of Urologic Pathology effectively eliminated Gleason patterns 1 and 2, thus removing Gleason grades 2-5 as a cancer diagnosis. Today, patients with low-risk Gleason 6 prostate cancer, prostate cancer clinicians, guideline writers, and policymakers are facing issues about whether Gleason 6 lesions should be reclassified as noncancer. Some of the issues being discussed among urologists, radiation oncologists, and pathologists focus on whether to reclassify low-risk Gleason 6 prostate lesions as a noncancer with the goal of reducing patient anxiety and financial toxicity. We also asked about biopsy methods, which affects both the low-risk and favorable intermediate-risk populations, that have been a major topic in support organizations over the past two years. We conducted this survey of patients on active surveillance to determine where patients stand on these issues to help guide clinicians, policymakers, and guideline writers. Methods: We conducted a survey in October 2022 asking patients their views on these issues. We invited patients on active surveillance or previously on active surveillance for low-risk prostate cancer to respond to a 40-question survey to share their views on a range of topics related to the diagnosis of Gleason grade 6 lesions as cancer, as well as complementary issues related to innovations in biopsy and active surveillance. We had access to email lists containing ~2,500 names from the AnCan Foundation’s Active Surveillance Virtual Support Group, Active Surveillance Patients International, Prostate Cancer Support Canada, and The Active Surveillor newsletter. Other major prostate cancer support groups also distributed links to the questionnaire posted on SurveyMonkey. Results: At the deadline for placeholders for abstracts, the survey is underway. Questions for patients include: Have you experienced distress (anxiety or depression) because of the cancer label from Gleason 6? Have you experienced financial toxicity, including cancellation of insurance policies or an increase in rates, because of the cancer diagnosis? If Gleason 6 was reclassified as a noncancer, would you stop surveillance? What will you prefer as a next biopsy--transperineal to avoid the risk of sepsis and other infections or transrectal which may cause less immediate pain? Conclusions: We intend that the results will inform decision making as to the classification of Gleason 6 diagnoses.

INTRODUCTION AND OBJECTIVE:The FDA cleared HIFU for prostate tissue ablation in 2015. This study aims to explore patient preferences regarding the known benefit and important adverse events associa...

INTRODUCTION AND OBJECTIVE:Prostate biopsy is the golden standard for the diagnosis of prostate cancer (PCa). The discordance between the PCa Grade Group (GG) on biopsy (Bx) and the PCa GG from the...

INTRODUCTION AND OBJECTIVE:While PSA has traditionally been used for prostate cancer (PCa) risk stratification, prostate MRI has more recently allowed improved diagnosis of clinically significant P...

Background/aims Targeted magnetic resonance imaging/ ultrasound (MRI/US) guided biopsy is an emerging technology that has the potential to change standard of care for the diagnosis and management of prostate cancer. This technology is rapidly proliferating, however quantitative analysis of these trends are unavailable. The objective of this study was to assess urologist opinions regarding implementing MRI/ US imaging into their practices. Methods A questionnaire was distributed using research electronic data capture and completed by 291 practicing urologists within the United States registered through the American Urological Association. The survey gathered information regarding demographics, changes in MRI use, opinions on targeted MRI/US guided biopsy, and barriers to implementation. The survey results were analyzed using ANOVA. Results Practice setting and geographic region were signifIcantly associated with implementation of MRI/US guided biopsy. Total 72% of urologists in academic centers report using MRI/US targeted biopsy, compared to 38% in solo private practice. In the northeast 68% of urologists report using MRI/US biopsy, compared to 44% in the western United States. Conclusion While there are some reservations about employing MRI/US guided biopsy as standard of care in all prostate biopsies, the data suggests urologists support its use, and are making efforts to introduce targeted MRI/US guided biopsy into their practice. Regional and practice setting variations exist in implementation.

Background While magnetic resonance imaging (MRI)-targeted biopsy (TBx) results in better prostate cancer (PCa) detection relative to systematic biopsy (SBx), the combination of both methods increases clinically significant PCa detection relative to either Bx method alone. However, combined Bx subjects patients to higher number of Bx cores and greater detection of clinically insignificant PCa. Objective To determine if prebiopsy prostate MRI can identify men who could forgo combined Bx without a substantial risk of missing clinically significant PCa (csPC). Design, setting, and participants Men with MRI-visible prostate lesions underwent combined TBx plus SBx. Outcome measurements and statistical analysis The primary outcomes were detection rates for grade group (GG) ≥2 and GG ≥3 PCa by TBx and SBx, stratified by Prostate Imaging-Reporting and Data System (PI-RADS) score. Results and limitations Among PI-RADS 5 cases, nearly all csPCs were detected by TBx, as adding SBx resulted in detection of only 2.5% more GG ≥2 cancers. Among PI-RADS 3–4 cases, however, SBx addition resulted in detection of substantially more csPCs than TBx alone (8% vs 7.5%). Conversely, TBx added little to detection of csPC among men with PI-RADS 2 lesions (2%) relative to SBx (7.8%). Conclusions While combined Bx increases the detection of csPC among men with MRI-visible prostate lesions, this benefit was largely restricted to PI-RADS 3–4 lesions. Using a strategy of TBx only for PI-RADS 5 and combined Bx only for PI-RADS 3–4 would avoid excess biopsies for men with PI-RADS 5 lesions while resulting in a low risk of missing csPC (1%). Patient summary Our study investigated an optimized strategy to diagnose aggressive prostate cancer in men with an abnormal prostate MRI (magnetic resonance imaging) scan while minimizing the risk of excess biopsies. We used a scoring system for MRI scan images called PI-RADS. The results show that MRI-targeted biopsies alone could be used for men with a PI-RADS score of 5, while men with a PI-RADS score of 3 or 4 would benefit from a combination of MRI-targeted biopsy and systematic biopsy. This trial is registered at ClinicalTrials.gov as NCT00102544.

INTRODUCTION Complete pathologic response (pT0) at time of cystectomy after neoadjuvant chemotherapy (NAC) has been associated with significantly improved clinical outcomes. The goal of this study is to examine whether race is a predictor of pT0 response to NAC at time of cystectomy.We analyzed the records of patients diagnosed with a non-metastatic (M0) muscle-invasive (cT2+) urothelial cell bladder cancer in the National Cancer Database (NCDB) who underwent a cystectomy from 2006 to 2014. The cohort was stratified by whether the patient received NAC prior to cystectomy. Univariate and multivariate logistic regression models were used to assess for the effect of race on pathologic complete response after NAC.We identified 16,036 patients of which 3,195 patients (19.9 %) were treated with NAC prior to cystectomy. The total number of African American (AA) patients in this study was 848 (5.3 %). Compared to Caucasian patients receiving NAC, AA patients had a greater proportion of females and had lower income and education. The rate of pT0 in the surgery only group was 2.7% compared to 15.0% (p0.001) for patients treated with NAC. On multivariate analysis, patients of AA race that received NAC were less likely to achieve pT0 (OR = 0.55, 95% CI: 0.31-0.98, p = 0.04) when controlling for age, sex, co-morbidities income, education and timing of cystectomy after starting NAC.Our results suggest that African American patients are less likely to achieve pathologic complete response to NAC prior to cystectomy.

Background: With the advancement of imaging technology, focal therapy (FT) has been gaining acceptance for the treatment of select patients with localized prostate cancer (CaP). We aim to provide details of a formal physician consensus on the utilization of FT for patients with CaP who are discontinuing active surveillance (AS). Methods: A 3-stage Delphi consensus on CaP and FT was conducted. Consensus was defined as agreement by >= 80% of physicians. An in-person meeting was attended by 17 panelists to formulate the consensus statement. Results: Fifty-six respondents participated in this interdisciplinary consensus study (82% urologist, 16% radiologist, 2% radiation oncology). The participants confirmed that there is a role for FT in men discontinuing AS (48% strongly agree, 39% agree). The benefit of FT over radical therapy for men coming off AS is: less invasive (91%), has a greater likelihood to preserve erectile function (91%), has a greater likelihood to preserve urinary continence (91%), has fewer side effects (86%), and has early recovery post-treatment (80%). Patients will need to undergo mpMRI of the prostate and/or a saturation biopsy to determine if they are potential candidates for FT. Our limitations include respondent's biases and that the participants of this consensus may not represent the larger medical community. Conclusions: FT can be offered to men coming off AS between the age of 60 to 80 with grade group 2 localized cancer. This consensus from a multidisciplinary, multi-institutional, international expert panel provides a contemporary insight utilizing FT for CaP in select patients who are discontinuing AS. United States Department of Health & Human Services National Institutes of Health (NIH) - USA ; European Urological Scholarship Programme (EUSP)

Introduction: The litigious environment encompassing the medical–legal domain is an increasing concern for surgical fields, with urology being no exception. The objective of our study was to system...