Citations 2
Trial Design and Objectives for Patients With Prostate Cancer: Recommendations From the Prostate Cancer Working Group 4
Armstrong, Andrew J., Morris, M., Abida, Wassim , Aggarwal, Rahul R., Antonarakis, Emmanuel S., Attard, Gerhardt , Beltran, Himisha, Bryce, Alan H. , Carducci, Michael A. , Cheng, Heather H., Dahut, William L. , Emmett, Louise , Fizazi, Karim, Gafita, Andrei, George, Daniel J., Hermann, Ken, Hofman, Michael S., Hope, MD Thomas A., Hussain, Maha, Kelly, W. Kevin, Kuo, Phillip H. , Liu, Glenn X., Morgans, Alicia K., McKay, Rana R., Nanus, David, Nelson, P., Reichert, Zachery R. , Ryan, Charles J. , Sartor, A. Oliver, Schwartz, Lawrence H., Sharifi, Nima , Stadler, Walter M., Stein, M., Sternberg, Cora N., Szmulewitz, Russell Z., Tagawa, Scott T., Sokolova, Alexandra O., Wyatt, Alex, Yu, Evan Y., Halabi, S., Scher, Howard I., Group, for the PCWG4 Writing, Alumkal, Joshi J. , Aparicio, Ana, Barata, Pedro C., Drake, Charles G., Hamid, Anis , Heath, Elisabeth I. , Nauseef, Jones, Lage, Daniel E. , Mallak, Nadine , Patnaik, Akash, Prepelica, Kristofer, Rowe, Steven P., Slovin, Susan F. , Taplin, Mary‐Ellen , Zorko, Nicholas, Carducci, Michael A. , Halabi, Susan , Cheng, Heather H. , Antonarakis, Emmanuel S. , Morris, Michael J. , Armstrong, Andrew J. , Nauseef, Jones T. , Antonarakis, Emmanuel S. , Zorko, Nicholas A. , Armstrong, Andrew J , Morris, Michael J , Aggarwal, Rahul , Antonarakis, Emmanuel S , Beltran, Himisha , Bryce, Alan H , Cheng, Heather H , Chen, Delphine L , Chi, Kim N , Childs, Daniel S , Dahut, William , Emmett, Louise , Fizazi, Karim , Gafita, Andrei , George, Daniel J , Hermann, Ken , Hofman, Michael S , Hope, Thomas A , Hussain, Maha H A , Kelly, W Kevin , Kessler, Elizabeth , Lang, Joshua M , Liu, Glenn , Marshall, Catherine H , Morgans, Alicia K , McKay, Rana R , Nelson, Peter S , Paller, Channing J , Reichert, Zachery R , Sartor, A Oliver , Schöder, Heiko , Sharifi, Nima , Stadler, Walter M , Stein, Mark , Sternberg, Cora N , Szmulewitz, Russell Z , Tagawa, Scott T , Sokolova, Alexandra O , Wyatt, Alexander , Yamoah, Kosj , Yu, Evan Y , Halabi, Susan , Antonarakis, Emmanuel S , Zorko, Nicholas A , Nauseef, Jones T , N., Kim , Childs, Daniel S. , Fizazi, Karim , Gafita, Andrei , George, Daniel J. , Hofman, Michael S. , Lang, Joshua M. , Liu, Glenn , Marshall, Catherine H. , Morgans, Alicia K. , McKay, Rana R. , Paller, Channing J. , Sartor, Oliver , Schöder, Heiko , Schwartz, Lawrence H., Stadler, Walter M. , Tagawa, Scott T. , Scher, Howard I. , Aparicio, Ana, Barata, Pedro C. , Drake, Charles G. , Graff, Julie Nicole , Patnaik, Akash , Rathkopf, Dana E , Rettig, Matthew B.
Journal of Clinical Oncology | February 26, 2026 | Volume: 44 | Issue: 13 | Pages: 1249-1265
PURPOSE The continuous development of new imaging approaches, molecular phenotyping, genetic subtypes, prognosis assessments, and effective therapies across a range of disease states has created a need to redefine terminology and best practices for clinical trial conduct in patients with advanced prostate cancer. Methods We convened an international expert committee of diverse working groups, the Prostate Cancer Working Group 4 (PCWG4), between 2016 and 2025. Our objective was to formulate updated criteria based on emerging evidence and clinical trial data in a biomarker context to provide guidance for clinical trial design, eligibility, and end point assessments for patients with advanced prostate cancer. RESULTS PCWG4 redefines terminology around the disease state and previous therapies in a patient-centric context and terminology focused on androgen pathway modulation. We consider imaging, with a particular focus on positron emission tomography (PET)–defined disease. New recommendations are provided for disease state terminology, defining eligibility criteria, response and delay/prevent end points, intervals for reassessments including imaging, and patient-reported outcome determination. We provide recommendations in a biomarker-based context of use for the intended indication, reflective of patient benefit for specific interventions. We emphasize the need for development of validated PET imaging and molecular and phenotypic criteria as well as trial designs to appropriately risk stratify patients, predict and assess benefit, and measure post-treatment outcomes reliably in a trial framework. CONCLUSION PCWG4 updates recommendations on patient and tumor characterization, therapy development, and imaging criteria and extends guidance into earlier androgen pathway modulator–naïve/sensitive disease states to reflect an evolving, heterogeneous, and diverse patient population to optimize treatment benefits for all patients.
IRONMAN: A Novel International Registry of Men With Advanced Prostate Cancer
Mucci, Lorelei A. , Vinson, Jacob, Gold, Theresa Margaret, Gerke, Travis , Filipenko, Julie, Green, Rebecca , Anderson, Simon , Badal, Simone , Bjartell, Anders , N., Kim , Davis, Ian D. , Enting, Deborah , Fay, André P. , Mateo, Joaquı́n , McDermott, Ray , Olmos, David , Omlin, Aurelius , Popoola, Ademola , Ragin, Camille , Roberts, Robin , Russnes, Kjell M. , Waihenya, Charles, Hyslop, Terry , Villanti, Paul , George, Daniel J. , Team, on behalf of the IRONMAN Global, Green, Rebecca M , Anderson, Simon G , Chi, Kim N , Mateo, Joaquin , McDermott, Ray , Odedina, Folakemi , Olmos, David , Omlin, Aurelius , Popoola, Ademola A , Ragin, Camille , Roberts, Robin , Stopsack, Konrad H , George, Daniel J , Lazarus, J. Michael , Stopsack, Konrad H. , Kantoff, Philip W. , Team, on behalf of the IRONMAN Global
JCO Global Oncology | November 4, 2022 | Volume: No volume available | Issue: 8 | Pages: No page available
PURPOSE To describe a newly established international registry recruiting diverse patients with advanced prostate cancer across academic and community practices to address unmet needs in this population. PATIENTS AND METHODS Initiated in 2017, IRONMAN (International Registry for Men with Advanced Prostate Cancer) is a prospective cohort of patients with advanced prostate cancer. The study will enroll 5,000 patients with metastatic hormone-sensitive prostate cancer (mHSPC) or castration-resistant prostate cancer (CRPC), recruited from Australia, the Bahamas, Barbados, Brazil, Canada, Ireland, Jamaica, Kenya, Nigeria, Norway, South Africa, Spain, Sweden, Switzerland, the United Kingdom, and the United States. The study is collecting datatypes to study variation in care and treatment of advanced prostate cancer across countries and across academic, community-based, and government practices with a focus on clinical outcomes, patient-reported outcomes, epidemiologic data, biologic subtypes, and clinician questionnaires. RESULTS Through July 2022, 2,682 eligible patients were enrolled in 11 of 12 active countries. Sixty-six percent of patients have mHSPC, and 34% have CRPC. On the basis of self-report, 11% of patients are Black and 9% are Hispanic. Five Veterans Affairs Medical Centers are enrolling patients. Globally, 23% of patients report being veterans of military service. CONCLUSION To our knowledge, this is the first international cohort of people newly diagnosed with advanced prostate cancer designed to describe variations in patient management, experiences, and outcomes. IRONMAN aims to identify optimal treatment sequences to improve survival, understand patient-reported outcomes, and explore novel biomarkers to understand treatment resistance mechanisms. Insights from IRONMAN will inform and guide future clinical management of people with mHSPC and CRPC. This cohort study will provide real-world evidence to facilitate a better understanding of the survivorship of people with advanced prostate cancer.