2f:I[703058,["/_next/static/immutable/chunks/3bhq_5eh1d760.js","/_next/static/immutable/chunks/1855-ogyi8eh4.js","/_next/static/immutable/chunks/2pfsjpn6k6zlg.js","/_next/static/immutable/chunks/26c7v3_3uwnwu.js","/_next/static/immutable/chunks/25a3ozcrvi1ff.js","/_next/static/immutable/chunks/2r4wx50nvjh_4.js","/_next/static/immutable/chunks/23fsw06hsi5b1.js","/_next/static/immutable/chunks/06_yt270h41rg.js","/_next/static/immutable/chunks/3ezsiz-7shkna.js","/_next/static/immutable/chunks/20x2y96ldu5wx.js","/_next/static/immutable/chunks/2lxntcm3pd1_h.js","/_next/static/immutable/chunks/00dgco8irq3jw.js","/_next/static/immutable/chunks/00nwe-kq0rboc.js","/_next/static/immutable/chunks/2051ffx3xzio9.js"],"PaperListPageClient"] 30:T780,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. 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. 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. 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.31:T9c9, 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. 25:[[["$","script","0",{"type":"application/ld+json","dangerouslySetInnerHTML":{"__html":"{\"@context\":\"https://schema.org\",\"@type\":\"CollectionPage\",\"name\":\"Clinical Practice Guideline / Expert Consensus: study design Research & Clinical Takeaways\",\"description\":\"Explore peer-reviewed papers on Clinical Practice Guideline / Expert Consensus (study design). 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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.","abstract":"$30","keywords":[],"pubmed_id":"41744290","conclusions":"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.","publication_date":"2026-02-26T00:00:00"},"crossref":{"DOI":"10.1200/jco-25-02834","URL":"https://doi.org/10.1200/jco-25-02834","ISSN":["0732-183X","1527-7755"],"link":[{"URL":"https://ascopubs.org/doi/pdfdirect/10.1200/JCO-25-02834","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"page":"1249-1265","type":"journal-article","issue":"13","score":1,"title":["Trial Design and Objectives for Patients With Prostate Cancer: Recommendations From the Prostate Cancer Working Group 4"],"author":[{"given":"Andrew J.","family":"Armstrong","sequence":"first","affiliation":[{"name":"Department of Medicine, Duke Cancer Institute Center for Prostate and Urologic Cancer, Duke University, Durham, NC"}]},{"given":"Michael J.","family":"Morris","sequence":"additional","affiliation":[{"name":"Memorial Sloan Kettering Cancer Center, New York, NY"}]},{"given":"Wassim","family":"Abida","sequence":"additional","affiliation":[{"name":"Memorial Sloan Kettering Cancer Center, New York, NY"}]},{"given":"Rahul R.","family":"Aggarwal","sequence":"additional","affiliation":[{"name":"San Francisco Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, CA"}]},{"given":"Emmanuel S.","family":"Antonarakis","sequence":"additional","affiliation":[{"name":"Masonic Cancer Center, University of Minnesota, Minneapolis, MN"}]},{"given":"Gerhardt","family":"Attard","sequence":"additional","affiliation":[{"name":"University College London Cancer Institute, London, United Kingdom"}]},{"given":"Himisha","family":"Beltran","sequence":"additional","affiliation":[{"name":"Dana Farber Cancer Institute, Boston, MA"}]},{"given":"Alan","family":"Bryce","sequence":"additional","affiliation":[{"name":"City of Hope Cancer Center, Goodyear, AZ"}]},{"given":"Michael A.","family":"Carducci","sequence":"additional","affiliation":[{"name":"Sidney Kimmel Cancer Center, Johns Hopkins University, Baltimore, MD"}]},{"given":"Heather H.","family":"Cheng","sequence":"additional","affiliation":[{"name":"University of Washington and Fred Hutchinson Cancer Center, Seattle, WA"}]},{"given":"Delphine L.","family":"Chen","sequence":"additional","affiliation":[{"name":"University of Washington and Fred Hutchinson Cancer Center, Seattle, WA"}]},{"given":"Kim N.","family":"Chi","sequence":"additional","affiliation":[{"name":"BC Cancer Agency, Vancouver, BC, Canada"}]},{"given":"Daniel S.","family":"Childs","sequence":"additional","affiliation":[{"name":"Department of Oncology, Mayo Clinic, Rochester, MN"}]},{"given":"William","family":"Dahut","sequence":"additional","affiliation":[{"name":"American Cancer Society, Atlanta, GA"}]},{"given":"Louise","family":"Emmett","sequence":"additional","affiliation":[{"name":"Department of Theranostics and Nuclear Medicine, St Vincent's Hospital, Sydney, Australia"}]},{"given":"Karim","family":"Fizazi","sequence":"additional","affiliation":[{"name":"Department of Cancer Medicine, Centre Oscar Lambret, Institut Gustave Roussy, University of Paris Saclay, Villejuif, France"}]},{"given":"Andrei","family":"Gafita","sequence":"additional","affiliation":[{"name":"Department of Radiology and Radiological Sciences, Johns Hopkins Theranostics Center, Johns Hopkins University, Baltimore, MD"}]},{"given":"Daniel J.","family":"George","sequence":"additional","affiliation":[{"name":"Department of Medicine, Duke Cancer Institute Center for Prostate and Urologic Cancer, Duke University, Durham, NC"}]},{"given":"Ken","family":"Hermann","sequence":"additional","affiliation":[{"name":"Universitätsklinikum Essen, Essen, Germany"}]},{"given":"Michael S.","family":"Hofman","sequence":"additional","affiliation":[{"name":"Peter MacCallum Cancer Centre, Melbourne, VIC, Australia"},{"name":"University of Melbourne, Parkville, VIC, Australia"}]},{"given":"Thomas","family":"Hope","sequence":"additional","affiliation":[{"name":"University of California, San Francisco, San Francisco, CA"}]},{"given":"Maha","family":"Hussain","sequence":"additional","affiliation":[{"name":"Robert H. 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level of evidence reflects expert opinion.","value_numeric":null}],"summaries":{"what_studied":"PCWG4, an international expert committee convened 2016–2025, updated clinical trial design guidance for advanced prostate cancer — covering disease-state terminology, eligibility criteria, imaging (with a focus on PSMA-PET), response/progression end points, biomarker frameworks, and patient-reported outcomes across the full disease spectrum from localized to metastatic androgen pathway modulator–resistant (APMR) disease.","key_result":"Key recommendations include: (1) replacing 'castration-sensitive/resistant' with androgen pathway modulation–naïve/sensitive/resistant (APMN/APMS/APMR) terminology; (2) incorporating PSMA-PET as non-investigational for staging but investigational for response assessment; (3) updating the bone progression rule — ≥6 new lesions on a restaging scan no longer require a confirmatory scan (vs. the prior 2+2 rule for all cases); (4) endorsing four near-term candidate response biomarkers: pathologic response, PSA declines/nadir, CTC0, and ctDNA decline; 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