Prostate Cancer In Clinical Practice Research Articles

First-in-man study of the PSMA Minibody IR800-IAB2M for molecularly targeted intraoperative fluorescence guidance during radical prostatectomy

PurposeProstate-specific membrane antigen (PSMA) is increasingly used to image prostate cancer in clinical practice. We sought to develop and test a humanised PSMA minibody IAB2M conjugated to the fluorophore IRDye 800CW-NHS ester in men undergoing robot-assisted laparoscopic radical prostatectomy (RARP) to image prostate cancer cells during surgery.MethodsThe minibody was evaluated pre-clinically using PSMA positive/negative xenograft models, following which 23 men undergoing RARP between 2018 and 2020 received between 2.5 mg and 20 mg of IR800-IAB2M intravenously, at intervals between 24 h and 17 days prior to surgery. At every step of the procedure, the prostate, pelvic lymph node chains and extra-prostatic surrounding tissue were imaged with a dual Near-infrared (NIR) and white light optical platform for fluorescence in vivo and ex vivo. Histopathological evaluation of intraoperative and postoperative microscopic fluorescence imaging was undertaken for verification.ResultsTwenty-three patients were evaluated to optimise both the dose of the reagent and the interval between injection and surgery and secure the best possible specificity of fluorescence images. Six cases are presented in detail as exemplars. Overall sensitivity and specificity in detecting non-lymph-node extra-prostatic cancer tissue were 100% and 65%, and 64% and 64% respectively for lymph node positivity. There were no side-effects associated with administration of the reagent.ConclusionIntraoperative imaging of prostate cancer tissue is feasible and safe using IR800-IAB2M. Further evaluation is underway to assess the benefit of using the technique in improving completion of surgical excision during RARP.RegistrationISCRCTN10046036: https://www.isrctn.com/ISRCTN10046036.

P014 - Diagnostic accuracy of next generation imaging tests for prostate cancer in clinical practice

P014 - Diagnostic accuracy of next generation imaging tests for prostate cancer in clinical practice

Machine learning-based prediction model and visual interpretation for prostate cancer

BackgroundMost prostate cancers(PCa) rely on serum prostate-specific antigen (PSA) testing for biopsy confirmation, but the accuracy needs to be further improved. We need to continue to develop PCa prediction model with high clinical application value.MethodsBenign prostatic hyperplasia (BPH) and prostate cancer data were obtained from the Chinese National Clinical Medical Science Data Center for retrospective analysis. The model was constructed using the XGBoost algorithm, and patients’ age, body mass index (BMI), PSA-related parameters and serum biochemical parameters were used as model variables. Using decision analysis curve (DCA) to evaluate the clinical utility of the models. The shapley additive explanation (SHAP) framework was used to analyze the importance ranking and risk threshold of the variables.ResultsA total of 1915 patients were included in this study, including 823 (43.0%) were BPH patients and 1092 (57.0%) were PCa patients. The XGBoost model provided better performance (AUC 0.82) compared with f/tPSA (AUC 0.75),tPSA (AUC 0.68) and fPSA (AUC 0.61), respectively. Based on SHAP values, f/tPSA was the most important variable, and the top five most important biochemical parameter variables were inorganic phosphorus (P), potassium (K), creatine kinase MB isoenzyme (CKMB), low-density lipoprotein cholesterol (LDL-C), and creatinine (Cre). PCa risk thresholds for these risk markers were f/tPSA (0.13), P (1.29 mmol/L), K (4.29 mmol/L), CKMB ( 11.6U/L), LDL-C (3.05mmol/L) and Cre (74.5-99.1umol/L).ConclusionThe present model has advantages of wide-spread availability and high net benefit, especially for underdeveloped countries and regions. Furthermore, these risk thresholds can assist in the diagnosis and screening of prostate cancer in clinical practice.

Clinical observations of patients with metastatic castration-resistant prostate cancer living in the Tambov region

Treatment of patients with metastatic castration-resistant prostate cancer in clinical practice is a vital necessity and a challenging task since the causes of castration resistance are not fully understood. Adherence to treatment regimens in accordance with the National Clinical Guidelines allows to achieve an increase in both overall survival and progression-free survival, as well as to reduce the mortality rate in this category of patients. Administration of 1st-line treatment regimens stabilizes the disease in the majority of pancreatic cancer patients; in some cases, the disease becomes aggressive, distant metastases appear, most oſten in bones, lymph nodes, and internal organs, as demonstrated by three clinical observations presented in this article. The administration of enzalutamide (in 2 cases) and abiraterone acetate (in 1 case) at the stage of resistance to castration therapy allowed to obtain a complete “response” from visceral lesions, stabilise bone metastatic foci and increase the life expectancy of patients.

Prostate cancer in clinical practice. First experiences with apalutamide within the context of therapeutic program B.56

The article contains a case report of patient diagnosed with castration-resistant non-metastatic prostate cancer, treated with a novel androgen receptor inhibitor – apalutamide.

Multifunctional nanoprobe for multi-mode imaging and diagnosis of metastatic prostate cancer

The high incidence and complex subtypes of prostate cancer put forward higher requirements for accurate diagnosis. Furthermore, advanced prostate cancer is prone to metastasis. Single biological imaging mode faces a challenge of sensitive and fast bioimaging of metastasic prostate cancer. Thus, exploring a nanoprobe with multi-mode imaging function has an important impact on preoperative imaging and intraoperative visualization guide of metastatic prostate cancer. Herein, based on the optical properties and X-ray attenuation capability of Au nanodots as well as the slow electronic relaxation of Gd3+, we designed and fabricated the multifunctional nanoprobe Au/Gd nanodots for multi-mode imaging and accurate diagnosis of bone metastatic prostate cancer. The results showed that multiple imaging modes complement each other to achieve high-precision of metastasic prostate cancer detection and accurately guide treatment. In addition, in vitro/vivo experiments showed that Au/Gd nanodots had good biocompatibility and biosafety. Therefore, the prepared multifunctional nanoprobe may provide new strategies and insights for precise diagnosis of metastatic prostate cancer in clinical practice.

Difficulties and Recommendations for AI-Based Prediction of Prostate Cancer Aggressiveness in Digital Pathology

Prostate cancer is among the most common cancers in men with around 1.4 million new cases each year world-wide. A vital part in the diagnosis of prostate cancer is the evaluation of its severity using biopsies and histopathology. Recent progress in artificial intelligence-based image analysis has led to a flurry of algorithms for the automated analysis of prostate cancer histopathological data focusing on the detection of cancerous areas, the grading of cancer severity, and patient outcome. Some of these approaches have reached human expert-level performance and digital models trained directly on patient outcomes might surpass human performance in the future. Although these results hold great promise for the future usage of digital pathology in clinical settings, several bottlenecks remain to be addressed. Especially the robustness, reliability and trustworthiness of predictions must be guaranteed across a wide range of variation in protocols and instrumentation. While human experts are relatively robust to technical and biological variation in biopsies, artificial intelligence-based systems tend to struggle with differences in staining intensity, color, scanner type, and image resolution, impeding the clinical usage of digital models. In this work we highlight salient problems and minimal requirements of computational pathology for future use in clinical settings, while focusing on prostate cancer as a use case. In particular, we highlight data and model problems and solutions that include data variability, dataset size, and data annotations, as well as model robustness to data heterogeneity, model prediction confidence, and the explainability of model decisions. While model and data requirements for successful computational pathology in clinics will be highlighted, legal, ethical, and deployment requirements will not be addressed in this review. In summary, we provide a short overview of the field, salient problems, and potential solutions to harvest the full potential of digital pathology for prostate cancer in clinical practice.

Identification and Potential Use of Clusters of Patients With Colorectal Cancer and Patients With Prostate Cancer in Clinical Practice: Explorative Mixed Methods Study.

A steady increase in colorectal and prostate cancer survivors and patients with these cancers is expected in the upcoming years. As a result of primary cancer treatments, patients have numerous additional complaints, increasing the need for cancer aftercare. However, referrals to appropriate cancer aftercare remain inadequate, despite a wide range of aftercare options. Caregivers and patients often do not know which aftercare is the most appropriate for the individual patient. Since characteristics and complaints of patients within a diagnosis group may differ, predefined patient clusters could provide substantive and efficient support for professionals in the conversation about aftercare. By using advanced data analysis methods, clusters of patients who are different from one another within a diagnosis group can be identified. This study had a 2-fold objective: (1) to identify, visualize, and describe potential patient clusters within the colorectal and prostate cancer population and (2) to explore the potential usability of these clusters in clinical practice. First, we used cross-sectional data from patients with colorectal cancer and patients with prostate cancer provided by the population-based PROFILES (Patient-Reported Outcomes Following Initial Treatment and Long-Term Evaluation of Survivorship) registry, which were originally collected between 2008 and 2012. To identify and visualize different clusters among the 2 patient populations, we conducted cluster analyses by applying the K-means algorithm and multiple-factor analyses. Second, in a qualitative study, we presented the patient clusters to patients with prostate, patients with colorectal cancer, and oncology professionals. To assess the usability of these clusters, we held expert panel group interviews. The interviews were video recorded and transcribed. Three researchers independently performed content-directed data analyses to understand and describe the qualitative data. Quotes illustrate the most important results. We identified 3 patient clusters among colorectal cancer cases (n=3989) and 5 patient clusters among prostate cancer cases (n=696), which were described in tabular form. Patient experts (6/8, 75%) and professional experts (17/20, 85%) recognized the patient clustering based on distinguishing variables. However, the tabular form was evaluated as less applicable in clinical practice. Instead, the experts suggested the development of a conversation tool (eg, decision tree) to guide professionals through the hierarchy of variables. In addition, participants suggested that information about possible aftercare initiatives should be offered and integrated. This would also ensure a good overview and seemed to be a precondition for finding suitable aftercare. This study demonstrates that a fully data-driven approach can be used to identify distinguishable and recognizable (ie, in routine care) patient clusters in large data sets within cancer populations. Patient clusters can be a source of support for health professionals in the aftercare conversation. These clusters, when integrated into a smart digital conversation and referral tool, might be an opportunity to improve referral to cancer aftercare. Netherlands Trial Register NL9226; https://trialsearch.who.int/Trial2.aspx?TrialID=NL9226.

P35-7 Analysis of BRCA1/2 mutations for metastatic castration resistant prostate cancer in clinical practice

Olaparib can be used for patients with metastatic castration resistant prostate cancer (mCRPC) who have altered BRCA1 or BRCA2. For the analysis of gene alterations, Foundation One CDx and BRACAnalysis are available in Japan. All patients with mCRPC who become resistant to 1st line androgen receptor axis targeted therapy are advised to receive the analysis. However, it is still unclear how these two analyses are recommended. In this study, we report the current status of BRCA1/2 analysis and examined the optimal strategy for detecting BRCA1/2 alterations in patients with mCRPC.

Molecular Characterization and Clinical Relevance of N6-Methyladenosine Regulators in Metastatic Prostate Cancer.

Prostate cancer is a leading malignancy in the male population globally. N6-methylation of adenosine (m6A) is the most prevalent mRNA modification and plays an essential role in various biological processes in vivo. However, the potential roles of m6A in metastatic prostate cancer are largely unknown. In this study, we evaluated and identified two m6A modification patterns based on 21 m6A regulators in four public metastatic prostate cancer datasets. Different modification patterns correlated with distinct molecular characteristics. According to m6A-associated genes, we constructed a prognostic model, called m6Ascore, to predict the outcomes of patients with metastatic prostate cancer. We found that high m6A score level was related to dismal prognosis and characterized by higher cell cycle, DNA repair and mismatch repair pathway score. In vitro experiments confirmed that upregulation of METTL14, an m6A writer, enhanced the invasion, metastasis, and sensitivity of prostate cancer cells to poly (ADP-ribose) polymerase inhibitor. Conversely, down-regulation of potential target genes of m6A had the opposite effect. Finally, we validated that a higher m6A score was associated with a worse prognosis and a higher Gleason score in The Cancer Genome Atlas Program (TCGA) cohort. This work illustrated the nonnegligible role of m6A modification in multiple biological processes of metastatic prostate cancer. Evaluating the m6A risk scores of individual tumours will guide more effective judgement of prognosis as well as treatments for metastatic prostate cancer in clinical practice.

Development of a highly sensitive digital PCR assay to quantify long non-coding RNA MYU in urine samples which exhibited great potential as an alternative diagnostic biomarker for prostate cancer.

BackgroundThe diagnostic methods of prostate cancer (PCa) present major drawbacks in that serum prostate specific antigen (PSA) testing lacks specificity for PCa and prostate needle biopsy is a painful and highly invasive procedure for patients. Thus, new alternative screening methods which are specific and non-invasive both in the early detection and in the clinical definitive diagnosis of PCa are in urgent need. Long non-coding RNA MYU has been shown to promote PCa cell proliferation and migration, and is significantly upregulated both at the cellular and tumor tissue level. Therefore, long non-coding RNA MYU may be a new potential diagnostic biomarker for PCa.MethodsIn the present study, we successfully developed a highly sensitive digital PCR assay to detect long non-coding RNA in clinical urine samples. dPCR was carried out using Qx200 ddPCR EvaGreen Supermix (Bio-Rad) according to the manufacturer’s instructions.ResultsOur results indicated that the digital PCR assay showed better linearity, repeatability, and reproducibility when compared with real-time quantitative PCR. In addition, we identified the normalized MYU level and used the digital PCR assay to measure it in 100 clinical urine samples. Our study showed that the normalized MYU level is a promising diagnostic biomarker for predicting and evaluating the malignancy of PCa.ConclusionsOur findings presented a non-invasive liquid biopsy method to detect an alternative diagnostic parameter which can assist the diagnosis of PCa in clinical practice.

Clinical drivers for imaging testing in non-metastatic castration-resistant prostate cancer in clinical practice: Results of the IDENTIFICA study

IntroductionThe aim of the study was to describe the clinical drivers that lead physicians to perform imaging tests in search of metastasis in non-metastasic castration prostate resistant cancer (nmCRPC) patients. MethodsObservational, cross-sectional study conducted at the Departments of Urology of 38 Spanish hospitals. The study included 188 patients diagnosed with nmCRPC who underwent an imaging test for the assessment of metástasis. In one study visit, physicians were requested to specify the clinical factors that led them to perform these tests. The results of the imaging tests and the clinical characteristics of the patients since the time of prostate cancer (PC) diagnosis, were reported. Regression analyses were used to determine predictors of imaging test results. ResultsProstate-specific antigen (PSA) level was the most important driver to order imaging tests (57.1%), followed by regular follow-up (16.5%) and PSA doubling time (PSADT) (12.0%). Although these drivers were not associated to detection of metastasis, patients with PSA levels ≥20 ng/mL had a greater risk of metastasis than patients with PSA levels <4 ng/mL (p = 0.004) and CRPC patients diagnosed with metastasis (mCRPC) had higher median PSA levels (20.9; interquartile range [IQR]: 6.7–38.6) than nmCRPC (9.1; IQR: 5.0–18.0) (p = 0.005). Sixty-six percent of the patients did not undergo any imaging test after CRPC diagnosis until the study visit (10.6, IQR: 4.0−19.5 months). Curative-intent treatment at PC diagnosis and Gleason score predicted longer time from PC to CRPC diagnosis. ConclusionsPhysicians based their decisions to order imaging tests for metastasis detection in nmCRPC patients mainly on PSA and PSA kinetics, including the regular follow-up stated by guideline recommendations.

Progress in Clinical Research on Gonadotropin-Releasing Hormone Receptor Antagonists for the Treatment of Prostate Cancer.

Gonadotropin-releasing hormone (GnRH) receptor agonists are still the most commonly used androgen deprivation treatment (ADT) drugs for prostate cancer in clinical practice. Currently, the GnRH receptor antagonists used for endocrine therapy for prostate cancer primarily include degarelix and relugolix (TAK-385). The former is administered by subcutaneous injection, while the latter is an oral drug. Compared to GnRH agonists, GnRH antagonists reduce serum testosterone levels more rapidly without an initial testosterone surge or subsequent microsurges. This review focuses on the mechanism of action of GnRH antagonists and agonists, the developmental history of GnRH antagonists, and emerging data from clinical studies of the two antagonists used as endocrine therapy for prostate cancer.

Effectiveness of Docetaxel for Metastatic Hormone-sensitive Prostate Cancer in Clinical Practice

BackgroundAddition of docetaxel to androgen deprivation therapy (ADT) for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC) has been proved to be effective with an overall survival (OS) benefit in phase III clinical trials. The effectiveness of docetaxel with ADT in the general patient population remains unknown. ObjectiveThe purpose of this study is to report the clinical experience in mHSPC patients treated with 3rd-weekly docetaxel plus ADT in routine practice at two Danish institutions. Design, setting and participantsA two-center retrospective study including consecutive mHSPC patients treated with 3rd-weekly docetaxel plus ADT was conducted. Outcome measurements and statistical analysisOutcomes of interest were OS, and biochemical and clinical progression-free survival. Results and limitationsA total of 173 consecutive patients with mHSPC who received docetaxel every 3rd week plus ADT between June 2015 and February 2018 were included. Most patients had high-volume disease (85%). All six planned docetaxel cycles were delivered in 149 cases (86%). Of the patients, 106 (61%) were alive at the last follow-up. At a median follow-up of 42 (37.8–58.6) mo, the median OS was 51.6 (41.5–56.3) mo. Castration-resistant prostate cancer (CRPC) developed in 46% within 1yr, with a median time to CRPC of 15.6 (13.0–18.1) mo. Prostate-specific antigen nadir ≤0.2ng/l was achieved in 15% of patients after 6 mo of ADT and in 19% after 12 mo. ConclusionsThe effect of docetaxel for mHSPC patients treated in routine practice appears comparable with the overall efficacy reported in the literature. Selection of patients will influence the results in clinical practice and clinical studies. Patient summaryIn this report, we looked at the clinical effectiveness of docetaxel combined with androgen deprivation therapy in men with metastatic hormone-sensitive prostate cancer (mHSPC) in a Danish population. We found the effect of docetaxel treatment for mHSPC in the general population to be comparable with the overall efficacy reported in published studies.

Optimizing outcomes for patients with metastatic prostate cancer: insights from South East Asia Expert Panel.

Aims:Clinical decision making is challenging in men with metastatic prostate cancer (mPC), as heterogeneity in treatment options and patient characteristics have resulted in multiple scenarios with little or no evidence. The South East Asia Expert Panel 2019 addressed some of these challenges.Methods:Based on evidence in the literature and expert interviews, 19 statements were formulated for key challenges in the treatment of men with castration-sensitive and -resistant prostate cancer in clinical practice. A modified Delphi process was used to reach consensus among experts in the panel and develop clinical practice recommendations.Results:The majority of the panel preferred a risk-based stratification and recommended abiraterone or enzalutamide as first-line therapy for symptomatic chemotherapy naïve patients. Abiraterone is preferred over enzalutamide as a first-line treatment in these patients. However, the panel did not support the use of abiraterone in high risk lymph-node positive only (N+M0) or in non-metastatic (N0M0) patients. In select patients, low dose abiraterone with food may be used to optimize clinical outcomes. Androgen receptor gene splice variant status may be a useful guide to therapy. In addition, generic versions of approved therapies may improve access to treatment to a broader patient population. The choice of treatment, as well as sequencing are guided by both patient and disease characteristics, preferences, drug access, cost, and compliance.Conclusion:Expert recommendations are key to guidance for the optimal management of mPC. Appropriate choice, timing, and sequence of treatment options can help to tailor therapy to maximize outcomes in men with mPC.

Management of Advanced Prostate Cancer in Clinical Practice: Real-World Answers to Challenging Dilemmas.

Advanced prostate cancer is a continuum of states distinguished by the presence or absence of metastasis and sensitivity or resistance to androgen deprivation therapy (ADT). Therapeutic options for this disease continue to rapidly evolve, making it a challenge to apply results of clinical trial data to daily patient management. One question relevant to providers is whether molecular biomarkers predictive of response or resistance to therapies are available to guide clinical treatment decisions. Other salient topics include the timing of therapy initiation in patients with biochemical recurrence, treatment approach in low-volume versus high-volume metastatic castrate-sensitive prostate cancer, types of agents available beyond ADT, and timing of their use in men with nonmetastatic castrate-resistant prostate cancer as well as whether sequencing of therapies in metastatic castrate-resistant prostate cancer matters. Additionally, familiarity with emerging treatment strategies is important. This review addresses the gray areas and challenging questions in advanced prostate cancer management that frequently arise in clinical practice.

Strategies for Testosterone Therapy in Men with Metastatic Prostate Cancer in Clinical Practice: Introducing Modified Bipolar Androgen Therapy

Purpose: To investigate prostate-specific antigen (PSA) and clinical responses to a variety of treatment strategies involving testosterone therapy (TTh) in men with metastatic prostate cancer (mPCa). Materials and Methods: Case records were reviewed for three men with advanced PCa treated with TTh for improved quality of life. Two had bone metastases and nephrostomies at baseline. The third had biochemical recurrence, and continued TTh after developing bone metastases. All rejected androgen deprivation therapy, desired improved quality of life with TTh, and accepted the risk of rapid PCa progression and death. Results: All men experienced substantial symptomatic and health benefits during TTh, including improved strength, vigor, and sexuality. Two reversed substantial weight loss. A 94-year-old man with baseline PSA of 546 ng/mL survived 11 months with continuous TTh, with last PSA of 2493 ng/mL. Two men in their 60s received some form of TTh for 3.5 and 8 years, respectively, and are still alive. None experienced sudden major adverse events. Continuous TTh resulted in progressive rise in PSA to high values. The combination of TTh and enzalutamide provided moderate protection against weakness and fatigue with PSA <10ng/mL for 6 months. PSA values fluctuated from <1.0 to >100 ng/mL within 1–2 months depending on recent androgen status. The most promising strategy appears to be a modified bipolar androgen therapy consisting of repeating cycles of 8 weeks of high-dose TTh followed by 4 weeks of enzalutamide, allowing for prolonged periods of vigor while maintaining PSA control. Conclusions: These pilot results support explorations of new hormonal strategies involving TTh for men with mPCa.

Distinct Metabolic Signatures of Hormone-Sensitive and Castration-Resistant Prostate Cancer Revealed by a 1H NMR-Based Metabolomics of Biopsy Tissue.

Tumor metabolic characteristics have been associated with the progression of prostate cancer (PCa), but little information is available regarding the metabolic alterations from hormone-sensitive (HSPC) to castration-resistant PCa (CRPC). In this study, therefore, we investigated the metabolic profiles in prostate tissues from patients with benign prostatic hyperplasia (BPH), HSPC, and CRPC using a 1H NMR-based metabolomics approach. The results show that clear separations in metabolic patterns were obtained in prostate tissues among BPH, HSPC, and CRPC; however, CRPC may induce a metabolic shift toward BPH, mainly involving amino acid metabolism, choline metabolism, and the Warburg effect. Based on these metabolic changes, we identified potential biomarker panels for the discrimination between BPH vs HSPC, BPH vs CRPC, and HSPC vs CRPC with the AUC values of 0.995, 0.972, and 0.937, respectively. Collectively, tissue-based metabolomics analysis not only identifies the altered metabolic pathways during PCa progression but also has the potential to help the classification and diagnosis of PCa in clinical practice.

Standardized Nomenclature and Surveillance Methodologies After Focal Therapy and Partial Gland Ablation for Localized Prostate Cancer: An International Multidisciplinary Consensus

BackgroundFocal therapy (FT) and partial gland ablation (PGA) are quickly adopted by urologists and radiologists as an option for the management of localized prostate cancer. ObjectiveTo find consensus on a standardized nomenclature and to define a follow-up guideline after FT and PGA for localized prostate cancer in clinical practice. Design, setting, and participantsA review of the literature identified controversial topics in the field of FT. Online questionnaires were distributed to experts during three rounds, with the goal to achieve consensus on debated topics. The consensus project was concluded with a face-to-face meeting in which final conclusions were formulated. Outcome measurements and statistical analysisControlled feedback of responses of previous rounds were summarized and returned to the participants allowing them to re-evaluate their decisions. The level of agreement to achieve consensus on a topic was set at 80%. Results and limitationsSixty-five experts participated in this interdisciplinary consensus study (72% urologists; 28% radiologists). The experts propose the use of the herein standardized nomenclature for ablative procedures. After FT/PGA, the following tests should be performed to assess treatment outcomes: prostate-specific antigen (PSA), imaging, biopsies, and functional outcome assessment. Although not a reliable marker for treatment failure, PSA should be measured every 3 mo in the 1st year and every 6 mo thereafter. Magnetic resonance imaging is the preferred image modality and should be performed at 6 and 18 mo after treatment. A systematic 12-core transrectal ultrasound-guided biopsy combined with a targeted biopsy of the treated area should be performed 6–12 mo after treatment. Functional outcomes should be obtained 3–6 mo after treatment for the first time and until stability is attained. ConclusionsThe panel recommends the use of the proposed nomenclature and follow-up protocols to generate reliable data supporting a broader implementation of FT as a standard of care for select patients with localized prostate cancer. Patient summaryIn this report, we present expert opinion on the use of a standardized nomenclature, and surveillance methodologies after focal therapy and partial gland ablation for localized prostate cancer.

Fluorine-18-Labeled Fluciclovine PET/CT in Clinical Practice: Factors Affecting the Rate of Detection of Recurrent Prostate Cancer.

OBJECTIVE. The purpose of this study is to show the performance and evaluate the factors influencing the positivity rate (PR) of commercially produced 18F-fluciclovine PET/CT in the detection of recurrent prostate cancer in clinical practice. MATERIALS AND METHODS. We performed a retrospective cohort study of 152 men who had suspected biochemical recurrence of prostate cancer after receiving initial treatment and underwent fluciclovine PET/CT. PRs were calculated for whole-body, prostate and prostate bed, and extraprostatic locations. The influence of different factors, such as the absolute prostate-specific antigen (PSA) level, PSA kinetics, the Gleason score, and Gleason grade groups, on the PR was evaluated. RESULTS. The overall PR was 81% (123/152) for the whole body, 61% (92/152) for the prostate and prostate bed, and 55% (83/152) for extraprostatic locations. There was a linear increase in the PR with an increasing PSA level (p < 0.001). For the whole body, the PR for PSA levels of less than 1 ng/mL, 1 to less than 2 ng/mL, 2 to less than 5 ng/mL, and 5 or more ng/mL were 58% (32/55), 87% (13/15), 100% (39/39), and 92% (35/38), respectively. No statistically significant linear trend was found between the PR and the PSA level doubling time (p > 0.05). In addition, no statistically significant linear trend was found between the PR and increasing Gleason grade group. However, for every 1-unit increase in a patient's Gleason score, the odds of a positive finding in the extraprostatic location increased by 49% (p < 0.05). CONCLUSION. Commercially produced fluciclovine PET/CT has a high PR for detection of prostate cancer recurrence and is positively correlated with increasing PSA levels. For extraprostatic disease, the PR increases with higher Gleason scores.