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1. Synergizing Data Imputation and Electronic Health Records for Advancing Prostate Cancer Research: Challenges, and Practical Applications

Author

Batouche, Abderrahim Oussama, Czeizler, Eugen, Koskinen, Miika, Mirtti, Tuomas, and Rannikko, Antti Sakari

Subjects
Computer Science - Information Retrieval, Computer Science - Databases
Abstract

The presence of detailed clinical information in electronic health record (EHR) systems presents promising prospects for enhancing patient care through automated retrieval techniques. Nevertheless, it is widely acknowledged that accessing data within EHRs is hindered by various methodological challenges. Specifically, the clinical notes stored in EHRs are composed in a narrative form, making them prone to ambiguous formulations and highly unstructured data presentations, while structured reports commonly suffer from missing and/or erroneous data entries. This inherent complexity poses significant challenges when attempting automated large-scale medical knowledge extraction tasks, necessitating the application of advanced tools, such as natural language processing (NLP), as well as data audit techniques. This work aims to address these obstacles by creating and validating a novel pipeline designed to extract relevant data pertaining to prostate cancer patients. The objective is to exploit the inherent redundancies available within the integrated structured and unstructured data entries within EHRs in order to generate comprehensive and reliable medical databases, ready to be used in advanced research studies. Additionally, the study explores potential opportunities arising from these data, offering valuable prospects for advancing research in prostate cancer.

Published
2023

3. Augment like there's no tomorrow: Consistently performing neural networks for medical imaging

Author

Pohjonen, Joona, Stürenberg, Carolin, Föhr, Atte, Randen-Brady, Reija, Luomala, Lassi, Lohi, Jouni, Pitkänen, Esa, Rannikko, Antti, and Mirtti, Tuomas

Subjects
Electrical Engineering and Systems Science - Image and Video Processing, Computer Science - Computer Vision and Pattern Recognition
Abstract

Deep neural networks have achieved impressive performance in a wide variety of medical imaging tasks. However, these models often fail on data not used during training, such as data originating from a different medical centre. How to recognize models suffering from this fragility, and how to design robust models are the main obstacles to clinical adoption. Here, we present general methods to identify causes for model generalisation failures and how to circumvent them. First, we use $\textit{distribution-shifted datasets}$ to show that models trained with current state-of-the-art methods are highly fragile to variability encountered in clinical practice, and then develop a $\textit{strong augmentation}$ strategy to address this fragility. Distribution-shifted datasets allow us to discover this fragility, which can otherwise remain undetected after validation against multiple external datasets. Strong augmentation allows us to train robust models achieving consistent performance under shifts from the training data distribution. Importantly, we demonstrate that strong augmentation yields biomedical imaging models which retain high performance when applied to real-world clinical data. Our results pave the way for the development and evaluation of reliable and robust neural networks in clinical practice., Comment: Code for the paper is available from https://www.github.com/jopo666/StrongAugment

Published
2022

4. Classification of datasets with imputed missing values: does imputation quality matter?

Author

Shadbahr, Tolou, Roberts, Michael, Stanczuk, Jan, Gilbey, Julian, Teare, Philip, Dittmer, Sören, Thorpe, Matthew, Torne, Ramon Vinas, Sala, Evis, Lio, Pietro, Patel, Mishal, Collaboration, AIX-COVNET, Rudd, James H. F., Mirtti, Tuomas, Rannikko, Antti, Aston, John A. D., Tang, Jing, and Schönlieb, Carola-Bibiane

Subjects
Computer Science - Machine Learning
Abstract

Classifying samples in incomplete datasets is a common aim for machine learning practitioners, but is non-trivial. Missing data is found in most real-world datasets and these missing values are typically imputed using established methods, followed by classification of the now complete, imputed, samples. The focus of the machine learning researcher is then to optimise the downstream classification performance. In this study, we highlight that it is imperative to consider the quality of the imputation. We demonstrate how the commonly used measures for assessing quality are flawed and propose a new class of discrepancy scores which focus on how well the method recreates the overall distribution of the data. To conclude, we highlight the compromised interpretability of classifier models trained using poorly imputed data., Comment: 17 pages, 10 figures, 30 supplementary pages

Published
2022
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5. PRECISE Version 2: Updated Recommendations for Reporting Prostate Magnetic Resonance Imaging in Patients on Active Surveillance for Prostate Cancer

Author

Englman, Cameron, Maffei, Davide, Allen, Clare, Kirkham, Alex, Albertsen, Peter, Kasivisvanathan, Veeru, Baroni, Ronaldo Hueb, Briganti, Alberto, De Visschere, Pieter, Dickinson, Louise, Gómez Rivas, Juan, Haider, Masoom A., Kesch, Claudia, Loeb, Stacy, Macura, Katarzyna J., Margolis, Daniel, Mitra, Anita M., Padhani, Anwar R., Panebianco, Valeria, Pinto, Peter A., Ploussard, Guillaume, Puech, Philippe, Purysko, Andrei S., Radtke, Jan Philipp, Rannikko, Antti, Rastinehad, Art, Renard-Penna, Raphaele, Sanguedolce, Francesco, Schimmöller, Lars, Schoots, Ivo G., Shariat, Shahrokh F., Schieda, Nicola, Tempany, Clare M., Turkbey, Baris, Valerio, Massimo, Villers, Arnauld, Walz, Jochen, Barrett, Tristan, Giganti, Francesco, and Moore, Caroline M.

Published
2024
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6. Comparison of outcomes of different biopsy schedules among men on active surveillance for prostate cancer: An analysis of the G.A.P.3 global consortium database

Author

Beckmann, Kerri R, Bangma, Chris H, Helleman, Jozien, Bjartell, Anders, Carroll, Peter R, Morgan, Todd, Nieboer, Daan, Santaolalla, Aida, Trock, Bruce J, Valdagni, Riccardo, Roobol, Monique J, Trock, Bruce, Ehdaie, Behfar, Carroll, Peter, Filson, Christopher, Logothetis, Christopher, Klotz, Laurence, Pickles, Tom, Hyndman, Eric, Moore, Caroline, Gnanapragasam, Vincent, Van Hemelrijck, Mieke, Dasgupta, Prokar, Bangma, Chris, Roobol, Monique, Villers, Arnauld, Robert, Grégoire, Semjonow, Axel, Rannikko, Antti, Perry, Antoinette, Hugosson, Jonas, Rubio‐Briones, Jose, Hefermehl, Lukas, Shiong, Lee Lui, Frydenberg, Mark, Stricker, Phillip, Sugimoto, Mikio, Chung, Byung Ha, van der Kwast, Theo, van der Linden, Wim, Hulsen, Tim, Ruwe, Boris, van Hooft, Peter, Steyerberg, Ewout, Beckmann, Kerri, Denton, Brian, Hayen, Andrew, Boutros, Paul, Guo, Wei, Benfante, Nicole, Cowan, Janet, Patil, Dattatraya, Park, Lauren, Ferrante, Stephanie, Mamedov, Alexandre, LaPointe, Vincent, Crump, Trafford, Stavrinides, Vasilis, Kimberly‐Duffell, Jenna, Olivier, Jonathan, Rancati, Tiziana, Ahlgren, Helén, Mascarós, Juanma, Löfgren, Annica, Lehmann, Kurt, Lin, Catherine Han, Cusick, Thomas, Hirama, Hiromi, Lee, Kwang Suk, Jenster, Guido, Auvinen, Anssi, Haider, Masoom, van Bochove, Kees, Kouspou, Michelle, and Paich, Kellie

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Urologic Diseases, Aging, Prevention, Cancer, Prostate Cancer, Clinical Research, Biopsy, Disease Progression, Humans, Male, Neoplasm Grading, Prostate, Prostate-Specific Antigen, Prostatic Neoplasms, Watchful Waiting, active surveillance, biopsy schedule, prostate cancer, treatment, upgrading, Global Action Plan Active Surveillance Prostate Cancer [G.A.P.3] Consortium, Paediatrics and Reproductive Medicine, Oncology & Carcinogenesis, Clinical sciences, Oncology and carcinogenesis
Abstract

BackgroundThe optimal interval for repeat biopsy during active surveillance (AS) for prostate cancer is yet to be defined. This study examined whether risk of upgrading (to grade group ≥ 2) or risk of converting to treatment varied according to intensity of repeat biopsy using data from the GAP3 consortium's global AS database.Materials and methodsIntensity of surveillance biopsy schedules was categorized according to centers' protocols: (a) Prostate Cancer Research International Active Surveillance project (PRIAS) protocols with biopsies at years 1, 4, and 7 (10 centers; 7532 men); (b) biennial biopsies, that is, every other year (8 centers; 4365 men); and (c) annual biopsy schedules (4 centers; 1602 men). Multivariable Cox regression was used to compare outcomes according to biopsy intensity.ResultsOut of the 13,508 eligible participants, 56% were managed according to PRIAS protocols (biopsies at years 1, 4, and 7), 32% via biennial biopsy, and 12% via annual biopsy. After adjusting for baseline characteristics, risk of converting to treatment was greater for those on annual compared with PRIAS biopsy schedules (hazard ratio [HR] = 1.66; 95% confidence interval [CI] = 1.51-1.83; p

Published
2022

8. Prostate Cancer Patients Under Active Surveillance with a Suspicious Magnetic Resonance Imaging Finding Are at Increased Risk of Needing Treatment: Results of the Movember Foundation’s Global Action Plan Prostate Cancer Active Surveillance (GAP3) Consortium

Author

Olivier, Jonathan, Li, Weiyu, Nieboer, Daan, Helleman, Jozien, Roobol, Monique, Gnanapragasam, Vincent, Frydenberg, Mark, Sugimoto, Mikio, Carroll, Peter, Morgan, Todd M, Valdagni, Riccardo, Rubio-Briones, Jose, Robert, Grégoire, Stricker, Phillip, Hayen, Andrew, Schoots, Ivo, Haider, Masoom, Moore, Caroline M, Denton, Brian, Villers, Arnauld, Trock, Bruce, Ehdaie, Behfar, Filson, Christopher, Logothetis, Christopher, Morgan, Todd, Klotz, Laurence, Pickles, Tom, Hyndman, Eric, Van Hemelrijck, Mieke, Dasgupta, Prokar, Bangma, Chris, Semjonow, Axel, Rannikko, Antti, Perry, Antoinette, Hugosson, Jonas, Bjartell, Anders, Hefermehl, Lukas, Shiong, Lee Lui, Chung, Byung Ha, van der Kwast, Theo, Hulsen, Tim, van der Linden, Wim, Ruwe, Boris, van Hooft, Peter, Steyerberg, Ewout, Boutros, Paul, Guo, Wei, Benfante, Nicole, Cowan, Janet, Patil, Dattatraya, Park, Lauren, Ferrante, Stephanie, Mamedov, Alexandre, LaPointe, Vincent, Crump, Trafford, Stavrinides, Vasilis, Kimberly-Duffell, Jenna, Santaolalla, Aida, Rancati, Tiziana, Ahlgren, Helén, Mascarós, Juanma, Löfgren, Annica, Lehmann, Kurt, Lin, Catherine Han, Cusick, Thomas, Hirama, Hiromi, Lee, Kwang Suk, Jenster, Guido, Auvinen, Anssi, van Bochove, Kees, Kouspou, Michelle, and Paich, Kellie

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Prevention, Clinical Research, Biomedical Imaging, Clinical Trials and Supportive Activities, Aging, Cancer, Urologic Diseases, Prostate Cancer, Detection, screening and diagnosis, 4.2 Evaluation of markers and technologies, Magnetic resonance imaging, Prostate cancer, Active surveillance, Discontinuation, Worldwide, Nomogram, Movember Foundation's Global Action Plan Prostate Cancer Active Surveillance GAP3 Consortium, Urology & Nephrology, Clinical sciences
Abstract

BackgroundThe inclusion criterion for active surveillance (AS) is low- or intermediate-risk prostate cancer. The predictive value of the presence of a suspicious lesion at magnetic resonance imaging (MRI) at the time of inclusion is insufficiently known.ObjectiveTo evaluate the percentage of patients needing active treatment stratified by the presence or absence of a suspicious lesion at baseline MRI.Design setting and participantsA retrospective analysis of the data from the multicentric AS GAP3 Consortium database was conducted. The inclusion criteria were men with grade group (GG) 1 or GG 2 prostate cancer combined with prostate-specific antigen

Published
2022

9. Weak Supervision and Clustering-Based Sample Selection for Clinical Named Entity Recognition

Author

Sun, Wei, Ji, Shaoxiong, Denti, Tuulia, Moen, Hans, Kerro, Oleg, Rannikko, Antti, Marttinen, Pekka, Koskinen, Miika, Goos, Gerhard, Founding Editor, Hartmanis, Juris, Founding Editor, Bertino, Elisa, Editorial Board Member, Gao, Wen, Editorial Board Member, Steffen, Bernhard, Editorial Board Member, Yung, Moti, Editorial Board Member, De Francisci Morales, Gianmarco, editor, Perlich, Claudia, editor, Ruchansky, Natali, editor, Kourtellis, Nicolas, editor, Baralis, Elena, editor, and Bonchi, Francesco, editor

Published
2023
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10. Spectral decoupling allows training transferable neural networks in medical imaging

Author

Pohjonen, Joona, Stürenberg, Carolin, Rannikko, Antti, Mirtti, Tuomas, and Pitkänen, Esa

Subjects
Electrical Engineering and Systems Science - Image and Video Processing, Computer Science - Artificial Intelligence, Computer Science - Computer Vision and Pattern Recognition, Computer Science - Machine Learning, Statistics - Machine Learning
Abstract

Many current neural networks for medical imaging generalise poorly to data unseen during training. Such behaviour can be caused by networks overfitting easy-to-learn, or statistically dominant, features while disregarding other potentially informative features. For example, indistinguishable differences in the sharpness of the images from two different scanners can degrade the performance of the network significantly. All neural networks intended for clinical practice need to be robust to variation in data caused by differences in imaging equipment, sample preparation and patient populations. To address these challenges, we evaluate the utility of spectral decoupling as an implicit bias mitigation method. Spectral decoupling encourages the neural network to learn more features by simply regularising the networks' unnormalised prediction scores with an L2 penalty, thus having no added computational costs. We show that spectral decoupling allows training neural networks on datasets with strong spurious correlations and increases networks' robustness for data distribution shifts. To validate our findings, we train networks with and without spectral decoupling to detect prostate cancer tissue slides and COVID-19 in chest radiographs. Networks trained with spectral decoupling achieve up to 9.5 percent point higher performance on external datasets. Our results show that spectral decoupling helps with generalisation issues associated with neural networks, and can be used to complement or replace computationally expensive explicit bias mitigation methods, such as stain normalization in histological images. We recommend using spectral decoupling as an implicit bias mitigation method in any neural network intended for clinical use., Comment: 10 pages, 7 figures and 2 tables

Published
2021
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11. Improving Prostate Cancer Detection with Breast Histopathology Images

Author

Khan, Umair Akhtar Hasan, Stürenberg, Carolin, Gencoglu, Oguzhan, Sandeman, Kevin, Heikkinen, Timo, Rannikko, Antti, and Mirtti, Tuomas

Subjects
Computer Science - Machine Learning, Computer Science - Computer Vision and Pattern Recognition, Statistics - Machine Learning
Abstract

Deep neural networks have introduced significant advancements in the field of machine learning-based analysis of digital pathology images including prostate tissue images. With the help of transfer learning, classification and segmentation performance of neural network models have been further increased. However, due to the absence of large, extensively annotated, publicly available prostate histopathology datasets, several previous studies employ datasets from well-studied computer vision tasks such as ImageNet dataset. In this work, we propose a transfer learning scheme from breast histopathology images to improve prostate cancer detection performance. We validate our approach on annotated prostate whole slide images by using a publicly available breast histopathology dataset as pre-training. We show that the proposed cross-cancer approach outperforms transfer learning from ImageNet dataset., Comment: 9 pages, 2 figures

Published
2019
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12. Genome-wide mRNA profiling in urinary extracellular vesicles reveals stress gene signature for diabetic kidney disease

Author

Dwivedi, Om Prakash, Barreiro, Karina, Käräjämäki, Annemari, Valo, Erkka, Giri, Anil K., Prasad, Rashmi B., Roy, Rishi Das, Thorn, Lena M., Rannikko, Antti, Holthöfer, Harry, Gooding, Kim M., Sourbron, Steven, Delic, Denis, Gomez, Maria F., Groop, Per-Henrik, Tuomi, Tiinamaija, Forsblom, Carol, Groop, Leif, and Puhka, Maija

Published
2023
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14. EMBARK post hoc analysis of impact of treatment suspension (TxS) on health-related quality of life (HRQoL).

Author

Freedland, Stephen J., primary, Gleave, Martin, additional, De Giorgi, Ugo, additional, Rannikko, Antti, additional, Saad, Fred, additional, Ramirez-Backhaus, Miguel, additional, Nasr, Anchen F., additional, Ivanova, Jasmina I., additional, Ganguli, Arijit, additional, Kral, Pavol, additional, Reisman, Arlene, additional, and Shore, Neal D., additional

Published
2024
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15. EMBARK post hoc analysis of sexual activity (SA) patient-reported outcomes (PROs) in patients (pts) who were sexually active or interested in sex at baseline (BL).

Author

Freedland, Stephen J., primary, Mulhall, John, additional, Gleave, Martin, additional, De Giorgi, Ugo, additional, Rannikko, Antti, additional, Saad, Fred, additional, Ramirez-Backhaus, Miguel, additional, Ivanova, Jasmina I., additional, Nasr, Anchen F., additional, Ganguli, Arijit, additional, Kral, Pavol, additional, Reisman, Arlene, additional, and Shore, Neal D., additional

Published
2024
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21. Reasons for Discontinuing Active Surveillance: Assessment of 21 Centres in 12 Countries in the Movember GAP3 Consortium

Author

Van Hemelrijck, Mieke, Ji, Xi, Helleman, Jozien, Roobol, Monique J, van der Linden, Wim, Nieboer, Daan, Bangma, Chris H, Frydenberg, Mark, Rannikko, Antti, Lee, Lui S, Gnanapragasam, Vincent J, Kattan, Mike W, Trock, Bruce, Ehdaie, Behfar, Carroll, Peter, Filson, Christopher, Kim, Jeri, Logothetis, Christopher, Morgan, Todd, Klotz, Laurence, Pickles, Tom, Hyndman, Eric, Moore, Caroline M, Gnanapragasam, Vincent, Dasgupta, Prokar, Bangma, Chris, Roobol, Monique, Villers, Arnauld, Valdagni, Riccardo, Perry, Antoinette, Hugosson, Jonas, Rubio-Briones, Jose, Bjartell, Anders, Hefermehl, Lukas, Shiong, Lee Lui, Kakehi, Yoshiyuki, Chung, Byung Ha, van der Kwast, Theo, Obbink, Henk, Hulsen, Tim, de Jonge, Cees, Kattan, Mike, Xinge, Ji, Muir, Kenneth, Lophatananon, Artitaya, Fahey, Michael, Steyerberg, Ewout, Zhang, Liying, Santa Olalla, Aida, Beckmann, Kerri, Denton, Brian, Hayen, Andrew, Boutros, Paul, Guo, Wei, Benfante, Nicole, Cowan, Janet, Patil, Dattatraya, Tolosa, Emily, Kim, Tae-Kyung, Mamedov, Alexandre, La Pointe, Vincent, Crump, Trafford, Kimberly-Duffell, Jenna, Santaolalla, Aida, Olivier, Jonathan, Rancati, Tiziana, Ahlgren, Helén, Mascarós, Juanma, Löfgren, Annica, Lehmann, Kurt, Lin, Catherine Han, Hirama, Hiromi, Lee, Kwang Suk, Jenster, Guido, Auvinen, Anssi, Haider, Masoom, van Bochove, Kees, Carter, Ballentine, Gledhill, Sam, Buzza, Mark, and Bruinsma, Sophie

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Prostate Cancer, Aging, Prevention, Urologic Diseases, Cancer, Good Health and Well Being, Aged, Asia, Australia, Biopsy, Cause of Death, Clinical Decision-Making, Databases, Factual, Disease Progression, Early Detection of Cancer, Europe, Humans, Kallikreins, Male, Middle Aged, North America, Patient Dropouts, Predictive Value of Tests, Prostate-Specific Antigen, Prostatic Neoplasms, Risk Assessment, Risk Factors, Time Factors, Watchful Waiting, Prostate cancer, Active surveillance, Discontinuation, Worldwide, Members of the Movember Foundation's Global Action Plan Prostate Cancer Active Surveillance GAP3 consortium, Urology & Nephrology, Clinical sciences
Abstract

BackgroundCareful assessment of the reasons for discontinuation of active surveillance (AS) is required for men with prostate cancer (PCa).ObjectiveUsing Movember's Global Action Plan Prostate Cancer Active Surveillance initiative (GAP3) database, we report on reasons for AS discontinuation.Design, setting, and participantsWe compared data from 10296 men on AS from 21 centres across 12 countries.Outcome measurements and statistical analysisCumulative incidence methods were used to estimate the cumulative incidence rates of AS discontinuation.Results and limitationsDuring 5-yr follow-up, 27.5% (95% confidence interval [CI]: 26.4-28.6%) men showed signs of disease progression, 12.8% (95% CI: 12.0-13.6%) converted to active treatment without evidence of progression, 1.7% (95% CI: 1.5-2.0%) continued to watchful waiting, and 1.7% (95% CI: 1.4-2.1%) died from other causes. Of the 7049 men who remained on AS, 2339 had follow-up for >5yr, 4561 had follow-up for

Published
2019

23. Active Surveillance for Men Younger than 60 Years or with Intermediate-risk Localized Prostate Cancer. Descriptive Analyses of Clinical Practice in the Movember GAP3 Initiative

Author

Trock, Bruce, Ehdaie, Behfar, Carroll, Peter, Filson, Christopher, Logothetis, Christopher, Morgan, Todd, Klotz, Laurence, Pickles, Tom, Hyndman, Eric, Moore, Caroline, Gnanapragasam, Vincent, Van Hemelrijck, Mieke, Dasgupta, Prokar, Bangma, Chris, Roobol, Monique, Villers, Arnauld, Robert, Grégoire, Semjonow, Axel, Rannikko, Antti, Valdagni, Riccardo, Perry, Antoinette, Hugosson, Jonas, Rubio-Briones, Jose, Bjartell, Anders, Hefermehl, Lukas, Lui Shiong, Lee, Frydenberg, Mark, Stricker, Phillip, Sugimoto, Mikio, Ha Chung, Byung, van der Kwast, Theo, van der Linden, Wim, Hulsen, Tim, Ruwe, Boris, Peter van Hooft, Steyerberg, Ewout, Nieboer, Daan, Beckmann, Kerri, Denton, Brian, Hayen, Andrew, Boutros, Paul, Guo, Wei, Benfante, Nicole, Cowan, Janet, Patil, Dattatraya, Park, Lauren, Ferrante, Stephanie, Mamedov, Alexandre, LaPointe, Vincent, Crump, Trafford, Stavrinides, Vasilis, Kimberly-Duffell, Jenna, Santaolalla, Aida, Olivier, Jonathan, Rancati, Tiziana, Ahlgren, Helén, Mascarós, Juanma, Löfgren, Annica, Lehmann, Kurt, Han Lin, Catherine, Cusick, Thomas, Hirama, Hiromi, Suk Lee, Kwang, Jenster, Guido, Auvinen, Anssi, Haider, Masoom, van Bochove, Kees, Kouspou, Michelle, Paich, Kellie, Helleman, Jozien, Remmers, Sebastiaan, Hyndman, Matthew E., Moore, Caroline M., Shiong Lee, Lui, Elhage, Oussama, Morgan, Todd M., Bangma, Chris H., and Roobol, Monique J.

Published
2022
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24. Characteristics of Patients in SPCG-15—A Randomized Trial Comparing Radical Prostatectomy with Primary Radiotherapy plus Androgen Deprivation Therapy in Men with Locally Advanced Prostate Cancer

Author

Gongora, Magdalena, Stranne, Johan, Johansson, Eva, Bottai, Matteo, Thellenberg Karlsson, Camilla, Brasso, Klaus, Hansen, Steinbjørn, Jakobsen, Henrik, Jäderling, Fredrik, Lindberg, Henriette, Lilleby, Wolfgang, Meidahl Petersen, Peter, Mirtti, Tuomas, Olsson, Mats, Rannikko, Antti, Røder, Martin Andreas, Henrik Vincent, Per, and Akre, Olof

Published
2022
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26. Prostate Cancer Patients Under Active Surveillance with a Suspicious Magnetic Resonance Imaging Finding Are at Increased Risk of Needing Treatment: Results of the Movember Foundation’s Global Action Plan Prostate Cancer Active Surveillance (GAP3) Consortium

Author

Trock, Bruce, Ehdaie, Behfar, Carroll, Peter, Filson, Christopher, Logothetis, Christopher, Morgan, Todd, Klotz, Laurence, Pickles, Tom, Hyndman, Eric, Moore, Caroline M, Gnanapragasam, Vincent, Van Hemelrijck, Mieke, Dasgupta, Prokar, Bangma, Chris, Roobol, Monique, Villers, Arnauld, Robert, Grégoire, Semjonow, Axel, Rannikko, Antti, Valdagni, Riccardo, Perry, Antoinette, Hugosson, Jonas, Rubio-Briones, Jose, Bjartell, Anders, Hefermehl, Lukas, Lui Shiong, Lee, Frydenberg, Mark, Stricker, Phillip, Sugimoto, Mikio, Ha Chung, Byung, van der Kwast, Theo, Hulsen, Tim, van der Linden, Wim, Ruwe, Boris, van Hooft, Peter, Steyerberg, Ewout, Nieboer, Daan, Denton, Brian, Hayen, Andrew, Boutros, Paul, Guo, Wei, Benfante, Nicole, Cowan, Janet, Patil, Dattatraya, Park, Lauren, Ferrante, Stephanie, Mamedov, Alexandre, LaPointe, Vincent, Crump, Trafford, Stavrinides, Vasilis, Kimberly-Duffell, Jenna, Santaolalla, Aida, Olivier, Jonathan, Rancati, Tiziana, Ahlgren, Helén, Mascarós, Juanma, Löfgren, Annica, Lehmann, Kurt, Han Lin, Catherine, Cusick, Thomas, Hirama, Hiromi, Suk Lee, Kwang, Jenster, Guido, Auvinen, Anssi, Haider, Masoom, van Bochove, Kees, Kouspou, Michelle, Paich, Kellie, Helleman, Jozien, Li, Weiyu, Morgan, Todd M., Schoots, Ivo, and Moore, Caroline M.

Published
2022
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27. Extended Safety and Tolerability of Darolutamide for Nonmetastatic Castration-Resistant Prostate Cancer and Adverse Event Time Course in ARAMIS.

Author

Shore, Neal D, Gratzke, Christian, Feyerabend, Susan, Werbrouck, Patrick, Carles, Joan, Vjaters, Egils, Tammela, Teuvo L J, Morris, David, Aragon-Ching, Jeanny B, Concepcion, Raoul S, Emmenegger, Urban, Fleshner, Neil, Grabbert, Markus, Lietuvietis, Vilnis, Mahammedi, Hakim, Cruz, Felipe M, Paula, Adriano, Pieczonka, Christopher, Rannikko, Antti, and Richardet, Martin

Subjects
THERAPEUTIC use of antineoplastic agents, CASTRATION-resistant prostate cancer, PATIENT safety, RESEARCH funding, DRUG side effects, DEATH, STATISTICAL sampling, BLIND experiment, TREATMENT effectiveness, RANDOMIZED controlled trials, METASTASIS, ANDROGEN receptors, DRUG tolerance, TIME, DISEASE incidence
Abstract

Background Patients with nonmetastatic castration-resistant prostate cancer (nmCRPC) are usually asymptomatic and seek treatments that improve survival but have a low risk of adverse events. Darolutamide, a structurally distinct androgen receptor inhibitor (ARi), significantly reduced the risk of metastasis and death versus placebo in ARAMIS. We assessed the extended safety and tolerability of darolutamide and the time-course profile of treatment-emergent adverse events (TEAEs) related to ARis and androgen-suppressive treatment. Patients and Methods Patients with nmCRPC were randomized 2:1 to darolutamide (n  = 955) or placebo (n  = 554). After trial unblinding, patients could receive open-label darolutamide. Tolerability and TEAEs were assessed every 16 weeks. Time interval–specific new and cumulative event rates were determined during the first 24 months of the double-blind period. Results Darolutamide remained well tolerated during the double-blind and open-label periods, with 98.8% of patients receiving the full planned dose. The incidence of TEAEs of interest in the darolutamide group was low and ≤2% different from that in the placebo group, except for fatigue. When incidences were adjusted for exposure time, there were minimal differences between the darolutamide double-blind and double-blind plus open-label periods. The rate of initial onset and cumulative incidence of grade 3/4 TEAEs and serious TEAEs were similar for darolutamide and placebo groups over 24 months. Conclusion Extended treatment with darolutamide was well tolerated and no new safety signals were observed. Most ARi-associated and androgen-suppressive treatment–related TEAEs occurred at low incidences with darolutamide, were similar to placebo, and showed minimal increase over time with continued treatment. Trial number ClinicalTrials.gov identifier NCT02200614 [ABSTRACT FROM AUTHOR]

Published
2024
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30. Comparison of Characteristics, Follow-up and Outcomes of Active Surveillance for Prostate Cancer According to Ethnicity in the GAP3 Global Consortium Database

Author

Trock, Bruce, Ehdaie, Behfar, Carroll, Peter, Filson, Christopher, Logothetis, Christopher, Morgan, Todd, Klotz, Laurence, Pickles, Tom, Hyndman, Eric, Moore, Caroline, Gnanapragasam, Vincent, Van Hemelrijck, Mieke, Dasgupta, Prokar, Bangma, Chris, Roobol, Monique, Villers, Arnauld, Robert, Grégoire, Semjonow, Axel, Rannikko, Antti, Valdagni, Riccardo, Perry, Antoinette, Hugosson, Jonas, Rubio-Briones, Jose, Bjartell, Anders, Hefermehl, Lukas, Lui Shiong, Lee, Frydenberg, Mark, Stricker, Phillip, Sugimoto, Mikio, Ha Chung, Byung, van der Kwast, Theo, van der Linden, Wim, Hulsen, Tim, Ruwe, Boris, van Hooft, Peter, Steyerberg, Ewout, Nieboer, Daan, Beckmann, Kerri, Denton, Brian, Hayen, Andrew, Boutros, Paul, Guo, Wei, Benfante, Nicole, Cowan, Janet, Patil, Dattatraya, Park, Lauren, Ferrante, Stephanie, Mamedov, Alexandre, LaPointe, Vincent, Crump, Trafford, Stavrinides, Vasilis, Kimberly-Duffell, Jenna, Santaolalla, Aida, Olivier, Jonathan, Rancati, Tiziana, Ahlgren, Helén, Mascarós, Juanma, Löfgren, Annica, Lehmann, Kurt, Han Lin, Catherine, Cusick, Thomas, Hirama, Hiromi, Suk Lee, Kwang, Jenster, Guido, Auvinen, Anssi, Haider, Masoom, van Bochove, Kees, Kouspou, Michelle, Paich, Kellie, Helleman, Jozien, Shiong Lee, Lui, and Elhage, Oussama

Published
2021
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31. LONGITUDINAL CHANGES IN PATIENT-REPORTED OUTCOMES (PROs) IN PATIENTS WITH HIGH-RISK BIOCHEMICALLY RECURRENT (BCR) NONMETASTATIC CASTRATION-SENSITIVE PROSTATE CANCER (NMCSPC) FROM THE EMBARK STUDY

Author

Freedland, Stephen J., primary, Gleave, Martin, additional, De Giorgi, Ugo, additional, Rannikko, Antti, additional, Pieczonka, Christopher M., additional, Tutrone Jr, Ronald F., additional, Venugopal, Balaji, additional, Woo, Henry, additional, Backhaus, Miguel Ramirez, additional, Supiot, Stephane, additional, Lantz, Anna, additional, Ganguli, Arijit, additional, Ivanova, Jasmina, additional, Kral, Pavol, additional, Huang, Shu-Pin, additional, Saad, Fred, additional, and Shore, Neal, additional

Published
2024
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33. Associations of PTEN and ERG with Magnetic Resonance Imaging Visibility and Assessment of Non–organ-confined Pathology and Biochemical Recurrence After Radical Prostatectomy

Author

Eineluoto, Juho T., Sandeman, Kevin, Pohjonen, Joona, Sopyllo, Konrad, Nordling, Stig, Stürenberg, Carolin, Malén, Adrian, Kilpeläinen, Tuomas P., Santti, Henrikki, Petas, Anssi, Matikainen, Mika, Pellinen, Teijo, Järvinen, Petrus, Kenttämies, Anu, Rannikko, Antti, and Mirtti, Tuomas

Published
2021
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37. Prostate Cancer Screening With PSA, Kallikrein Panel, and MRI: The ProScreen Randomized Trial.

Author

Auvinen, Anssi, Tammela, Teuvo L. J., Mirtti, Tuomas, Lilja, Hans, Tolonen, Teemu, Kenttämies, Anu, Rinta-Kiikka, Irina, Lehtimäki, Terho, Natunen, Kari, Nevalainen, Jaakko, Raitanen, Jani, Ronkainen, Johanna, van der Kwast, Theodorus, Riikonen, Jarno, Pétas, Anssi, Matikainen, Mika, Taari, Kimmo, Kilpeläinen, Tuomas, and Rannikko, Antti S.

Abstract

Importance: Prostate-specific antigen (PSA) screening has potential to reduce prostate cancer mortality but frequently detects prostate cancer that is not clinically important. Objective: To describe rates of low-grade (grade group 1) and high-grade (grade groups 2-5) prostate cancer identified among men invited to participate in a prostate cancer screening protocol consisting of a PSA test, a 4-kallikrein panel, and a magnetic resonance imaging (MRI) scan. Design, Setting, and Participants: The ProScreen trial is a clinical trial conducted in Helsinki and Tampere, Finland, that randomized 61 193 men aged 50 through 63 years who were free of prostate cancer in a 1:3 ratio to either be invited or not be invited to undergo screening for prostate cancer between February 2018 and July 2020. Interventions: Participating men randomized to the intervention underwent PSA testing. Those with a PSA level of 3.0 ng/mL or higher underwent additional testing for high-grade prostate cancer with a 4-kallikrein panel risk score. Those with a kallikrein panel score of 7.5% or higher underwent an MRI of the prostate gland, followed by targeted biopsies for those with abnormal prostate gland MRI findings. Final data collection occurred through June 31, 2023. Main Outcomes and Measures: In descriptive exploratory analyses, the cumulative incidence of low-grade and high-grade prostate cancer after the first screening round were compared between the group invited to undergo prostate cancer screening and the control group. Results: Of 60 745 eligible men (mean [SD] age, 57.2 [4.0] years), 15 201 were randomized to be invited and 45 544 were randomized not to be invited to undergo prostate cancer screening. Of 15 201 eligible males invited to undergo screening, 7744 (51%) participated. Among them, 32 low-grade prostate cancers (cumulative incidence, 0.41%) and 128 high-grade prostate cancers (cumulative incidence, 1.65%) were detected, with 1 cancer grade group result missing. Among the 7457 invited men (49%) who refused participation, 7 low-grade prostate cancers (cumulative incidence, 0.1%) and 44 high-grade prostate cancers (cumulative incidence, 0.6%) were detected, with 7 cancer grade groups missing. For the entire invited screening group, 39 low-grade prostate cancers (cumulative incidence, 0.26%) and 172 high-grade prostate cancers (cumulative incidence, 1.13%) were detected. During a median follow-up of 3.2 years, in the group not invited to undergo screening, 65 low-grade prostate cancers (cumulative incidence, 0.14%) and 282 high-grade prostate cancers (cumulative incidence, 0.62%) were detected. The risk difference for the entire group randomized to the screening invitation vs the control group was 0.11% (95% CI, 0.03%-0.20%) for low-grade and 0.51% (95% CI, 0.33%-0.70%) for high-grade cancer. Conclusions and Relevance: In this preliminary descriptive report from an ongoing randomized clinical trial, 1 additional high-grade cancer per 196 men and 1 low-grade cancer per 909 men were detected among those randomized to be invited to undergo a single prostate cancer screening intervention compared with those not invited to undergo screening. These preliminary findings from a single round of screening should be interpreted cautiously, pending results of the study's primary mortality outcome. Trial Registration: ClinicalTrials.gov Identifier: NCT03423303 This preliminary descriptive report compares the detection rates of high-grade and low-grade prostate cancer in men invited for prostate cancer screening vs those of the control group not offered screening. Key Points: Question: What were the rates of prostate cancer detection among men randomized to be invited to undergo prostate cancer screening compared with a control group not invited to undergo screening? Findings: In this preliminary report from an ongoing clinical trial, 60 745 men aged 50 through 63 years were randomized either to be invited to undergo prostate cancer screening with a PSA test, a 4-kallikrein panel for those with a PSA of 3.0 ng/mL or higher, and MRI or not to be invited for screening (control group). The risk difference for the group invited to be screened vs the control group was 0.11% for low-grade and 0.51% for high-grade prostate cancer. Meaning: In this preliminary descriptive report, the screening intervention detected 1 high-grade prostate cancer per 196 men and 1 low-grade prostate cancer per 909 men invited to be screened. These preliminary findings should be interpreted cautiously, pending results of the study's primary outcome of prostate cancer mortality. [ABSTRACT FROM AUTHOR]

Published
2024
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38. Adherence to Active Surveillance Protocols for Low-risk Prostate Cancer: Results of the Movember Foundation’s Global Action Plan Prostate Cancer Active Surveillance Initiative

Author

Trock, Bruce, Ehdaie, Behfar, Carroll, Peter, Filson, Christopher, Kim, Jeri, Logothetis, Christopher, Morgan, Todd, Klotz, Laurence, Pickles, Tom, Hyndman, Eric, Moore, Caroline M., Gnanapragasam, Vincent, Van Hemelrijck, Mieke, Dasgupta, Prokar, Bangma, Chris, Roobol, Monique, Villers, Arnauld, Rannikko, Antti, Valdagni, Riccardo, Perry, Antoinette, Hugosson, Jonas, Rubio-Briones, Jose, Bjartell, Anders, Hefermehl, Lukas, Shiong, Lee Lui, Frydenberg, Mark, Kakehi, Yoshiyuki, Chung, Byung Ha, van der Kwast, Theo, Obbink, Henk, van der Linden, Wim, Hulsen, Tim, Jonge, Cees de, Kattan, Mike, Xinge, Ji, Muir, Kenneth, Lophatananon, Artitaya, Fahey, Michael, Steyerberg, Ewout, Nieboer, Daan, Zhang, Liying, Beckmann, Kerri, Denton, Brian, Hayen, Andrew, Boutros, Paul, Guo, Wei, Benfante, Nicole, Cowan, Janet, Patil, Dattatraya, Tolosa, Emily, Kim, Tae-Kyung, Mamedov, Alexandre, LaPointe, Vincent, Crump, Trafford, Kimberly-Duffell, Jenna, Santaolalla, Aida, Olivier, Jonathan, Rancati, Tiziana, Ahlgren, Helén, Mascarós, Juanma, Löfgren, Annica, Lehmann, Kurt, Lin, Catherine Han, Hirama, Hiromi, Lee, Kwang Suk, Jenster, Guido, Auvinen, Anssi, Haider, Masoom, van Bochove, Kees, Carter, Ballentine, Gledhill, Sam, Buzza, Mark, Bruinsma, Sophie, Helleman, Jozien, Kalapara, Arveen A., Verbeek, Jan F.M., Lee, Lui Shiong, Bangma, Chris H., Steyerberg, Ewout W., Harkin, Tim, and Roobol, Monique J.

Published
2020
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39. Enzalutamide and Quality of Life in Biochemically Recurrent Prostate Cancer

Author

Freedland, Stephen J., primary, Gleave, Martin, additional, De Giorgi, Ugo, additional, Rannikko, Antti, additional, Pieczonka, Christopher M., additional, Tutrone, Ronald F., additional, Venugopal, Balaji, additional, Woo, Henry H., additional, Ramirez-Backhaus, Miguel, additional, Supiot, Stephane, additional, Lantz, Anna, additional, Ganguli, Arijit, additional, Ivanova, Jasmina, additional, Kral, Pavol, additional, Huang, Shu-Pin, additional, Saad, Fred, additional, and Shore, Neal D., additional

Published
2023
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40. Improved Outcomes with Enzalutamide in Biochemically Recurrent Prostate Cancer

Author

Freedland, Stephen J., primary, de Almeida Luz, Murilo, additional, De Giorgi, Ugo, additional, Gleave, Martin, additional, Gotto, Geoffrey T., additional, Pieczonka, Christopher M., additional, Haas, Gabriel P., additional, Kim, Choung-Soo, additional, Ramirez-Backhaus, Miguel, additional, Rannikko, Antti, additional, Tarazi, Jamal, additional, Sridharan, Swetha, additional, Sugg, Jennifer, additional, Tang, Yiyun, additional, Tutrone, Ronald F., additional, Venugopal, Balaji, additional, Villers, Arnauld, additional, Woo, Henry H., additional, Zohren, Fabian, additional, and Shore, Neal D., additional

Published
2023
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45. Histomic and transcriptomic features of MRI‐visible and invisible clinically significant prostate cancers are associated with prognosis.

Author

Lehto, Timo‐Pekka K., Pylväläinen, Juho, Sandeman, Kevin, Kenttämies, Anu, Nordling, Stig, Mills, Ian G., Tang, Jing, Mirtti, Tuomas, and Rannikko, Antti

Subjects
PROSTATE cancer, TRANSCRIPTOMES, MAGNETIC resonance imaging, PROSTATE biopsy, GENETIC transcription regulation, MEDICAL triage
Abstract

Magnetic resonance imaging (MRI) is increasingly used to triage patients for prostate biopsy. However, 9% to 24% of clinically significant (cs) prostate cancers (PCas) are not visible in MRI. We aimed to identify histomic and transcriptomic determinants of MRI visibility and their association to metastasis, and PCa‐specific death (PCSD). We studied 45 radical prostatectomy‐treated patients with csPCa (grade group [GG]2‐3), including 30 with MRI‐visible and 15 with MRI‐invisible lesions, and 18 men without PCa. First, histological composition was quantified. Next, transcriptomic profiling was performed using NanoString technology. MRI visibility‐associated differentially expressed genes (DEGs) and Reactome pathways were identified. MRI visibility was classified using publicly available genes in MSK‐IMPACT and Decipher, Oncotype DX, and Prolaris. Finally, DEGs and clinical parameters were used to classify metastasis and PCSD in an external cohort, which included 76 patients with metastatic GG2‐4 PCa, and 84 baseline‐matched controls without progression. Luminal area was lower in MRI‐visible than invisible lesions and low luminal area was associated with short metastasis‐free and PCa‐specific survival. We identified 67 DEGs, eight of which were associated with survival. Cell division, inflammation and transcriptional regulation pathways were upregulated in MRI‐visible csPCas. Genes in Decipher, Oncotype DX and MSK‐IMPACT performed well in classifying MRI visibility (AUC = 0.86‐0.94). DEGs improved classification of metastasis (AUC = 0.69) and PCSD (AUC = 0.68) over clinical parameters. Our data reveals that MRI‐visible csPCas harbor more aggressive histomic and transcriptomic features than MRI‐invisible csPCas. Thus, targeted biopsy of visible lesions may be sufficient for risk stratification in patients with a positive MRI. [ABSTRACT FROM AUTHOR]

Published
2024
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48. Expected impact of MRI-targeted biopsy interreader variability among uropathologists on ProScreen prostate cancer screening trial: a pre-trial validation study

Author

Hietikko, Ronja, primary, Mirtti, Tuomas, additional, Kilpelainen, Tuomas P, additional, Tolonen, Teemu, additional, Rasanen-Sokolowski, Anne, additional, Nordling, Stig, additional, Hannus, Jill, additional, Laurila, Marita, additional, Taari, Kimmo, additional, Tammela, Teuvo LJ, additional, Autio, Reija, additional, Natunen, Kari, additional, Auvinen, Anssi, additional, and Rannikko, Antti, additional

Published
2023
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