2f:I[703058,["/_next/static/immutable/chunks/3bhq_5eh1d760.js","/_next/static/immutable/chunks/2iy5wruuedsh6.js","/_next/static/immutable/chunks/2pfsjpn6k6zlg.js","/_next/static/immutable/chunks/26c7v3_3uwnwu.js","/_next/static/immutable/chunks/00yc7rcvua6a7.js","/_next/static/immutable/chunks/37ktb71aq3480.js","/_next/static/immutable/chunks/2d50b-7eu4558.js","/_next/static/immutable/chunks/06_yt270h41rg.js","/_next/static/immutable/chunks/2d6noqpp6ehas.js","/_next/static/immutable/chunks/1sx186c93bpzg.js","/_next/static/immutable/chunks/3dc-1n866s65i.js","/_next/static/immutable/chunks/20x2y96ldu5wx.js","/_next/static/immutable/chunks/2w1bvggzb0ga8.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:[[["$","script","0",{"type":"application/ld+json","dangerouslySetInnerHTML":{"__html":"{\"@context\":\"https://schema.org\",\"@type\":\"CollectionPage\",\"name\":\"lutetium-177 PSMA-617: generic Research & Clinical Takeaways\",\"description\":\"Explore peer-reviewed papers on lutetium-177 PSMA-617 (generic). Clinician-written summaries and actionable practice insights. Updated daily.\",\"url\":\"https://www.reachrx.ai/hub/tag/generic/lutetium-177%20PSMA-617\",\"breadcrumb\":{\"@type\":\"BreadcrumbList\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https://www.reachrx.ai\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Research Hub\",\"item\":\"https://www.reachrx.ai/hub\"},{\"@type\":\"ListItem\",\"position\":3,\"name\":\"Generics\",\"item\":\"https://www.reachrx.ai/hub/tag/generic\"},{\"@type\":\"ListItem\",\"position\":4,\"name\":\"lutetium-177 PSMA-617\",\"item\":\"https://www.reachrx.ai/hub/tag/generic/lutetium-177%20PSMA-617\"}]}}"}}]],["$","$L2f",null,{"title":"lutetium-177 PSMA-617: Research & Clinical Takeaways","description":"Explore research on lutetium-177 PSMA-617 (generic) — efficacy, safety, and comparative data.","papers":[{"doi":"10.1097/ju.0000000000005131","pmid":"42171515","title":"First-Line Systemic Treatments of Metastatic Hormone-Sensitive Prostate Cancer: Updated Systematic Review and Network Meta-Analysis","journal_title":"Journal of Urology","journal_issn":"0022-5347","published_at":"2026-05-22T00:00:00.000Z","url":"https://doi.org/10.1097/ju.0000000000005131","source_score":8,"is_retracted":false,"is_open_access":true,"raw_metadata":{"pubmed":true,"crossref":true,"unpaywall":true},"created_at":"2026-08-14T13:24:59.421Z","updated_at":"2026-08-14T13:24:59.421Z","tags":[{"paper_doi":"10.1097/ju.0000000000005131","tag_type":"age_group","value":"adult","value_numeric":null},{"paper_doi":"10.1097/ju.0000000000005131","tag_type":"age_group","value":"older_adult","value_numeric":null},{"paper_doi":"10.1097/ju.0000000000005131","tag_type":"brand","value":"Erleada","value_numeric":null},{"paper_doi":"10.1097/ju.0000000000005131","tag_type":"brand","value":"Nubeqa","value_numeric":null},{"paper_doi":"10.1097/ju.0000000000005131","tag_type":"brand","value":"Pluvicto","value_numeric":null},{"paper_doi":"10.1097/ju.0000000000005131","tag_type":"brand","value":"Xtandi","value_numeric":null},{"paper_doi":"10.1097/ju.0000000000005131","tag_type":"brand","value":"Zytiga","value_numeric":null},{"paper_doi":"10.1097/ju.0000000000005131","tag_type":"category","value":"Urology & Nephrology","value_numeric":null},{"paper_doi":"10.1097/ju.0000000000005131","tag_type":"condition","value":"Metastatic Hormone-Sensitive Prostate Cancer","value_numeric":null},{"paper_doi":"10.1097/ju.0000000000005131","tag_type":"generic","value":"abiraterone","value_numeric":null},{"paper_doi":"10.1097/ju.0000000000005131","tag_type":"generic","value":"apalutamide","value_numeric":null},{"paper_doi":"10.1097/ju.0000000000005131","tag_type":"generic","value":"capivasertib","value_numeric":null},{"paper_doi":"10.1097/ju.0000000000005131","tag_type":"generic","value":"darolutamide","value_numeric":null},{"paper_doi":"10.1097/ju.0000000000005131","tag_type":"generic","value":"docetaxel","value_numeric":null},{"paper_doi":"10.1097/ju.0000000000005131","tag_type":"generic","value":"enzalutamide","value_numeric":null},{"paper_doi":"10.1097/ju.0000000000005131","tag_type":"generic","value":"lutetium-177 PSMA-617","value_numeric":null},{"paper_doi":"10.1097/ju.0000000000005131","tag_type":"generic","value":"niraparib","value_numeric":null},{"paper_doi":"10.1097/ju.0000000000005131","tag_type":"impact_flag","value":"practice_changing","value_numeric":null},{"paper_doi":"10.1097/ju.0000000000005131","tag_type":"level_of_evidence","value":"1","value_numeric":null},{"paper_doi":"10.1097/ju.0000000000005131","tag_type":"modality","value":"AKT Inhibitor","value_numeric":null},{"paper_doi":"10.1097/ju.0000000000005131","tag_type":"modality","value":"Androgen Deprivation Therapy","value_numeric":null},{"paper_doi":"10.1097/ju.0000000000005131","tag_type":"modality","value":"Androgen Receptor Pathway Inhibitor","value_numeric":null},{"paper_doi":"10.1097/ju.0000000000005131","tag_type":"modality","value":"PARP Inhibitor","value_numeric":null},{"paper_doi":"10.1097/ju.0000000000005131","tag_type":"modality","value":"Radioligand Therapy","value_numeric":null},{"paper_doi":"10.1097/ju.0000000000005131","tag_type":"modality","value":"Taxane Chemotherapy","value_numeric":null},{"paper_doi":"10.1097/ju.0000000000005131","tag_type":"sample_size","value":"n=18689","value_numeric":18689},{"paper_doi":"10.1097/ju.0000000000005131","tag_type":"sex","value":"male","value_numeric":null},{"paper_doi":"10.1097/ju.0000000000005131","tag_type":"study_design","value":"Network Meta-Analysis","value_numeric":null},{"paper_doi":"10.1097/ju.0000000000005131","tag_type":"warning","value":"Biomarker-driven trials (AMPLITUDE, CAPItello-281, PSMAddition) were excluded from the NMA due to selected populations and evaluated qualitatively only; OS results are immature for all three.","value_numeric":null},{"paper_doi":"10.1097/ju.0000000000005131","tag_type":"warning","value":"PARPi+ARPI+ADT OS data were not available for inclusion in the NMA; OS benefit for this triplet remains unknown.","value_numeric":null},{"paper_doi":"10.1097/ju.0000000000005131","tag_type":"warning","value":"Several included trials had open-label designs, introducing risk of bias in investigator-assessed progression endpoints.","value_numeric":null},{"paper_doi":"10.1097/ju.0000000000005131","tag_type":"warning","value":"The impact_flag 'practice_changing' reflects the high-certainty subgroup finding for docetaxel triplet in high-volume disease and the emerging biomarker-driven data; the all-comer analysis does not confirm a practice change for unselected patients.","value_numeric":null},{"paper_doi":"10.1097/ju.0000000000005131","tag_type":"warning","value":"The NMA grouped all ARPIs (abiraterone, apalutamide, darolutamide, enzalutamide, orteronel, rezvilutamide) as a single class to preserve network connectivity; class-level effects may mask agent-specific differences.","value_numeric":null}],"summaries":{"what_studied":"This updated systematic review and network meta-analysis (NMA) compared the efficacy and safety of first-line systemic combination therapies for metastatic hormone-sensitive prostate cancer (mHSPC) across 23 RCTs (n=18,689), searched through March 2026. Outcomes included progression-free survival (PFS), overall survival (OS), and severe adverse events (AEs), with a separate systematic review of biomarker-driven trials (AMPLITUDE, CAPItello-281, PSMAddition).","key_result":"No triplet regimen showed a statistically significant OS benefit over ARPI+ADT in all-comers. However, **docetaxel+ARPI+ADT** significantly improved OS in high-volume disease (HR 0.76, 95% CI 0.61–0.95; high certainty). For PFS, docetaxel+ARPI+ADT (HR 0.66, 95% CI 0.43–1.01; moderate certainty) and PARPi+ARPI+ADT (HR 0.55, 95% CI 0.23–1.34; low certainty) showed clinically relevant but non-significant trends vs. ARPI+ADT. In biomarker-selected populations: niraparib+abiraterone improved rPFS in HRR-mutated mHSPC (HR 0.63); capivasertib+abiraterone improved rPFS in PTEN-deficient mHSPC (HR 0.81); Lu-177-PSMA+ARPI+ADT improved rPFS in PSMA-positive mHSPC (HR 0.72); OS data remain immature for all three.","limitations":"- Direct head-to-head comparisons between key triplet regimens were unavailable, requiring reliance on indirect NMA contrasts with interstudy heterogeneity.\n- Combining radiographic and clinical PFS endpoints introduced heterogeneity; earlier trials used conventional imaging vs. more sensitive modalities in recent trials, risking stage migration bias.\n- PARPi-, PSMA-, and AKT-based evidence comes from single trials with immature OS data and small phase II samples, yielding low or very low certainty.","practice_takeaway":"For patients with **high-volume mHSPC**, docetaxel+ARPI+ADT offers a proven OS benefit (HR 0.76; high certainty) and should be preferred. For patients with specific biomarkers (HRR mutation, PTEN loss, or PSMA-positive disease), targeted intensification with PARPi, AKT inhibitor, or radioligand therapy respectively shows rPFS benefit—but OS data are still maturing, so treatment decisions must weigh distinct toxicity profiles against uncertain long-term gains."}},{"doi":"10.1200/jco-25-02834","pmid":"41744290","title":"Trial Design and Objectives for Patients With Prostate Cancer: Recommendations From the Prostate Cancer Working Group 4","journal_title":"Journal of Clinical Oncology","journal_issn":"0732-183X","published_at":"2026-02-26T00:00:00.000Z","url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC13132095/","source_score":61,"is_retracted":false,"is_open_access":true,"raw_metadata":{"ooir":{"day":"2026-05-02","doi":"10.1200/jco-25-02834","days":"14","issn":"0732-183X","rank":"9","field":"Clinical Medicine","score":"61","category":"Oncology","categories":["Oncology"],"_categories":["Oncology"]},"pubmed":{"doi":"10.1200/JCO-25-02834","title":"Trial Design and Objectives for Patients With Prostate Cancer: Recommendations From the Prostate Cancer Working Group 4.","journal":"Journal of clinical oncology : official journal of the American Society of Clinical Oncology","methods":"","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.","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. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL"}]},{"given":"W. Kevin","family":"Kelly","sequence":"additional","affiliation":[{"name":"Sidney Kimmel School of Medicine at Thomas Jefferson University, Philadelphia, PA"}]},{"given":"Elizabeth","family":"Kessler","sequence":"additional","affiliation":[{"name":"University of Colorado School of Medicine, Aurora, CO"}]},{"given":"Phillip H.","family":"Kuo","sequence":"additional","affiliation":[{"name":"Department of Radiology, City of Hope National Medical Center, Duarte, CA"}]},{"given":"Joshua","family":"Lang","sequence":"additional","affiliation":[{"name":"University of Wisconsin Carbone Cancer Center, University of Wisconsin, Madison, WI"}]},{"given":"Glenn","family":"Liu","sequence":"additional","affiliation":[{"name":"University of Wisconsin Carbone Cancer Center, University of Wisconsin, Madison, WI"}]},{"given":"Catherine H.","family":"Marshall","sequence":"additional","affiliation":[{"name":"Sidney Kimmel Cancer Center, Johns Hopkins University, Baltimore, MD"}]},{"given":"Alicia K.","family":"Morgans","sequence":"additional","affiliation":[{"name":"Dana Farber Cancer Institute, Boston, MA"}]},{"given":"Rana R.","family":"McKay","sequence":"additional","affiliation":[{"name":"University of California San Diego, San Diego, CA"}]},{"given":"David","family":"Nanus","sequence":"additional","affiliation":[{"name":"Weill Cornell Medicine, New York, NY"},{"name":"Weill Cornell Medicine-NewYork Presbyterian Hospital, New York, NY"}]},{"given":"Peter","family":"Nelson","sequence":"additional","affiliation":[{"name":"Fred Hutchinson Cancer Center, Seattle, WA"}]},{"given":"Channing","family":"Paller","sequence":"additional","affiliation":[{"name":"Sidney Kimmel Cancer Center, Johns Hopkins University, Baltimore, MD"}]},{"given":"Zachery R.","family":"Reichert","sequence":"additional","affiliation":[{"name":"Department of Medicine, University of Michigan, Ann Arbor, MI"}]},{"given":"Charles J.","family":"Ryan","sequence":"additional","affiliation":[{"name":"Memorial Sloan Kettering Cancer Center, New York, NY"}]},{"given":"A. Oliver","family":"Sartor","sequence":"additional","affiliation":[{"name":"Transformational Prostate Cancer Research Center, LCMC Health, New Orleans, LA"}]},{"given":"Heiko","family":"Schöder","sequence":"additional","affiliation":[{"name":"Memorial Sloan Kettering Cancer Center, New York, NY"}]},{"given":"Lawrence H.","family":"Schwartz","sequence":"additional","affiliation":[{"name":"Memorial Sloan Kettering Cancer Center, New York, NY"}]},{"given":"Nima","family":"Sharifi","sequence":"additional","affiliation":[{"name":"University of Miami Miller School of Medicine, Miami, FL"}]},{"given":"Walter M.","family":"Stadler","sequence":"additional","affiliation":[{"name":"City of Hope Cancer Center, Chicago, IL"}]},{"given":"Mark","family":"Stein","sequence":"additional","affiliation":[{"name":"Herbert Irving Comprehensive Cancer Center, Columbia University Irving Medical Center, New York, NY"}]},{"given":"Cora N.","family":"Sternberg","sequence":"additional","affiliation":[{"name":"Englander Institute for Precision Medicine, Weill Cornell Medicine, New York, NY"},{"name":"Department of Medicine, Sandra and Edward Meyer Cancer Center, New York Presbyterian, New York, NY"}]},{"given":"Russell Z.","family":"Szmulewitz","sequence":"additional","affiliation":[{"name":"Department of Medicine, University of Chicago, Chicago, IL"}]},{"given":"Scott T.","family":"Tagawa","sequence":"additional","affiliation":[{"name":"Division of Hematology and Medical Oncology, Department of Medicine, Weill Cornell Medical College, New York, NY"}]},{"given":"Alexandra O.","family":"Sokolova","sequence":"additional","affiliation":[{"name":"Hematology Oncology, Oregon Health and Science University, Portland, OR"}]},{"given":"Alex W.","family":"Wyatt","sequence":"additional","affiliation":[{"name":"Department of Urologic Sciences, Vancouver Prostate Centre, University of British Columbia, Vancouver, BC, Canada"},{"name":"Michael Smith Genome Sciences Centre, BC Cancer, Vancouver, BC, Canada"}]},{"given":"Kosj","family":"Yamoah","sequence":"additional","affiliation":[{"name":"Department of Radiation Oncology, H. Lee Moffitt Cancer Center & Research Institute, Tampa, FL"},{"name":"James A. Haley Veterans' Hospital, Tampa, FL"}]},{"given":"Evan Y.","family":"Yu","sequence":"additional","affiliation":[{"name":"University of Washington and Fred Hutchinson Cancer Center, Seattle, WA"}]},{"given":"Susan","family":"Halabi","sequence":"additional","affiliation":[{"name":"Department of Biostatistics and Bioinformatics, Duke University Medical Center, Durham, NC"}]},{"given":"Howard I.","family":"Scher","sequence":"additional","affiliation":[{"name":"Memorial Sloan Kettering Cancer Center, New York, NY"}]},{"given":null,"family":null,"sequence":"additional","affiliation":[]},{"given":"Joshi J.","family":"Alumkal","sequence":"additional","affiliation":[]},{"given":"Ana","family":"Aparicio","sequence":"additional","affiliation":[]},{"given":"Pedro","family":"Barata","sequence":"additional","affiliation":[]},{"given":"Charles","family":"Drake","sequence":"additional","affiliation":[]},{"given":"Julie","family":"Graff","sequence":"additional","affiliation":[]},{"given":"Anis A.","family":"Hamid","sequence":"additional","affiliation":[]},{"given":"Elisabeth I.","family":"Heath","sequence":"additional","affiliation":[]},{"given":"Jones","family":"Nauseef","sequence":"additional","affiliation":[]},{"given":"Daniel","family":"Lage","sequence":"additional","affiliation":[]},{"given":"Nadine","family":"Mallak","sequence":"additional","affiliation":[]},{"given":"Akash","family":"Patnaik","sequence":"additional","affiliation":[]},{"given":"Kristofer","family":"Prepelica","sequence":"additional","affiliation":[]},{"given":"Dana E.","family":"Rathkopf","sequence":"additional","affiliation":[]},{"given":"Matthew","family":"Rettig","sequence":"additional","affiliation":[]},{"given":"Steven P.","family":"Rowe","sequence":"additional","affiliation":[]},{"given":"Susan F.","family":"Slovin","sequence":"additional","affiliation":[]},{"given":"Mary-Ellen","family":"Taplin","sequence":"additional","affiliation":[]},{"given":"Nicholas","family":"Zorko","sequence":"additional","affiliation":[]}],"issued":{"date-parts":[[2026,5,1]]},"member":"233","prefix":"10.1200","source":"Crossref","volume":"44","created":{"date-time":"2026-02-26T12:00:10Z","timestamp":1772107210000,"date-parts":[[2026,2,26]]},"indexed":{"date-time":"2026-05-01T07:54:32Z","timestamp":1777622072040,"date-parts":[[2026,5,1]]},"subject":[],"abstract":"$31","language":"en","relation":{},"resource":{"primary":{"URL":"https://ascopubs.org/doi/10.1200/JCO-25-02834"}},"subtitle":[],"assertion":[{"name":"received","group":{"name":"publication_history","label":"Publication History"},"label":"Received","order":0,"value":"2025-11-25"},{"name":"revised","group":{"name":"publication_history","label":"Publication History"},"label":"Revised","order":1,"value":"2025-12-14"},{"name":"accepted","group":{"name":"publication_history","label":"Publication History"},"label":"Accepted","order":2,"value":"2026-01-07"},{"name":"published","group":{"name":"publication_history","label":"Publication History"},"label":"Published","order":3,"value":"2026-02-26"}],"deposited":{"date-time":"2026-04-28T22:00:39Z","timestamp":1777413639000,"date-parts":[[2026,4,28]]},"issn-type":[{"type":"print","value":"0732-183X"},{"type":"electronic","value":"1527-7755"}],"published":{"date-parts":[[2026,5,1]]},"publisher":"American Society of Clinical Oncology (ASCO)","reference":[{"DOI":"10.1158/1078-0432.CCR-20-4573","key":"e_1_3_5_2_2","year":null,"issue":null,"author":null,"volume":null,"first-page":null,"unstructured":null,"article-title":null,"journal-title":null,"doi-asserted-by":"publisher"},{"DOI":"10.1097/JU.0000000000001698","key":"e_1_3_5_3_2","year":null,"issue":null,"author":null,"volume":null,"first-page":null,"unstructured":null,"article-title":null,"journal-title":null,"doi-asserted-by":"publisher"},{"DOI":"10.1056/NEJMoa2107322","key":"e_1_3_5_4_2","year":null,"issue":null,"author":null,"volume":null,"first-page":null,"unstructured":null,"article-title":null,"journal-title":null,"doi-asserted-by":"publisher"},{"DOI":"10.1016/S0140-6736(24)01653-2","key":"e_1_3_5_5_2","year":null,"issue":null,"author":null,"volume":null,"first-page":null,"unstructured":null,"article-title":null,"journal-title":null,"doi-asserted-by":"publisher"},{"DOI":"10.1056/NEJMoa1911440","key":"e_1_3_5_6_2","year":null,"issue":null,"author":null,"volume":null,"first-page":null,"unstructured":null,"article-title":null,"journal-title":null,"doi-asserted-by":"publisher"},{"DOI":"10.1016/S1470-2045(23)00382-0","key":"e_1_3_5_7_2","year":null,"issue":null,"author":null,"volume":null,"first-page":null,"unstructured":null,"article-title":null,"journal-title":null,"doi-asserted-by":"publisher"},{"DOI":"10.1016/S0140-6736(23)01055-3","key":"e_1_3_5_8_2","year":null,"issue":null,"author":null,"volume":null,"first-page":null,"unstructured":null,"article-title":null,"journal-title":null,"doi-asserted-by":"publisher"},{"DOI":"10.1016/S0140-6736(20)30314-7","key":"e_1_3_5_9_2","year":null,"issue":null,"author":null,"volume":null,"first-page":null,"unstructured":null,"article-title":null,"journal-title":null,"doi-asserted-by":"publisher"},{"DOI":"10.1200/JCO.2015.64.2702","key":"e_1_3_5_10_2","year":null,"issue":null,"author":null,"volume":null,"first-page":null,"unstructured":null,"article-title":null,"journal-title":null,"doi-asserted-by":"publisher"},{"DOI":null,"key":"e_1_3_5_11_2","year":"2016","issue":null,"author":"FDA-NIH Biomarker Working Group","volume":null,"first-page":null,"unstructured":"FDA-NIH Biomarker Working Group: BEST (Biomarkers, EndpointS, and other Tools) Resource. Silver Spring, MD, Bethesda, MD, US Food and Drug Administration; National Institutes of Health, 2016. https://www.ncbi.nlm.nih.gov/books/NBK326791/","article-title":null,"journal-title":null,"doi-asserted-by":null},{"DOI":"10.1136/esmoopen-2020-000943","key":"e_1_3_5_12_2","year":null,"issue":null,"author":null,"volume":null,"first-page":null,"unstructured":null,"article-title":null,"journal-title":null,"doi-asserted-by":"publisher"},{"DOI":"10.1016/j.eururo.2023.02.002","key":"e_1_3_5_13_2","year":null,"issue":null,"author":null,"volume":null,"first-page":null,"unstructured":null,"article-title":null,"journal-title":null,"doi-asserted-by":"publisher"},{"DOI":"10.1186/s40644-019-0211-y","key":"e_1_3_5_14_2","year":null,"issue":null,"author":null,"volume":null,"first-page":null,"unstructured":null,"article-title":null,"journal-title":null,"doi-asserted-by":"publisher"},{"DOI":null,"key":"e_1_3_5_15_2","year":null,"issue":null,"author":"Halabi S","volume":null,"first-page":null,"unstructured":"Halabi S, Guo S, Luo B, et al: Pathogenic genomic alterations in circulating tumor DNA predict overall survival in men with metastatic castrate-resistant prostate cancer. Eur Urol 10.1016/j.eururo.2025.07.011 [epub ahead of print on August 6, 2025]","article-title":"Pathogenic genomic alterations in circulating tumor DNA predict overall survival in men with metastatic castrate-resistant prostate cancer","journal-title":"Eur Urol","doi-asserted-by":null},{"DOI":"10.1200/JCO.2013.52.3696","key":"e_1_3_5_16_2","year":null,"issue":null,"author":null,"volume":null,"first-page":null,"unstructured":null,"article-title":null,"journal-title":null,"doi-asserted-by":"publisher"},{"DOI":"10.1016/j.eururo.2020.04.061","key":"e_1_3_5_17_2","year":null,"issue":null,"author":null,"volume":null,"first-page":null,"unstructured":null,"article-title":null,"journal-title":null,"doi-asserted-by":"publisher"},{"DOI":"10.1016/S1470-2045(24)00326-7","key":"e_1_3_5_18_2","year":null,"issue":null,"author":null,"volume":null,"first-page":null,"unstructured":null,"article-title":null,"journal-title":null,"doi-asserted-by":"publisher"},{"DOI":"10.1016/j.euo.2024.03.009","key":"e_1_3_5_19_2","year":null,"issue":null,"author":null,"volume":null,"first-page":null,"unstructured":null,"article-title":null,"journal-title":null,"doi-asserted-by":"publisher"},{"DOI":"10.1200/JCO.19.01479","key":"e_1_3_5_20_2","year":null,"issue":null,"author":null,"volume":null,"first-page":null,"unstructured":null,"article-title":null,"journal-title":null,"doi-asserted-by":"publisher"},{"DOI":"10.1001/jamaoncol.2017.5808","key":"e_1_3_5_21_2","year":null,"issue":null,"author":null,"volume":null,"first-page":null,"unstructured":null,"article-title":null,"journal-title":null,"doi-asserted-by":"publisher"},{"DOI":null,"key":"e_1_3_5_22_2","year":"2015","issue":null,"author":"Morris M","volume":"33","first-page":null,"unstructured":"Morris M, Higano C, Scher H, et al: Effects of radium-223 dichloride (Ra-223) with docetaxel (D) vs D on prostate-specific antigen (PSA) and bone alkaline phosphatase (bALP) in patients (pts) with castration-resistant prostate cancer (CRPC) and bone metastases (mets): A phase 1/2a clinical trial. J Clin Oncol 33, 2015 (suppl 15; abstr 5012)","article-title":"Effects of radium-223 dichloride (Ra-223) with docetaxel (D) vs D on prostate-specific antigen (PSA) and bone alkaline phosphatase (bALP) in patients (pts) with castration-resistant prostate cancer (CRPC) and bone metastases (mets): A phase 1/2a clinical trial","journal-title":"J Clin Oncol","doi-asserted-by":null},{"DOI":"10.1200/JCO.22.02394","key":"e_1_3_5_23_2","year":null,"issue":null,"author":null,"volume":null,"first-page":null,"unstructured":null,"article-title":null,"journal-title":null,"doi-asserted-by":"publisher"},{"DOI":"10.1002/cncr.35438","key":"e_1_3_5_24_2","year":null,"issue":null,"author":null,"volume":null,"first-page":null,"unstructured":null,"article-title":null,"journal-title":null,"doi-asserted-by":"publisher"},{"DOI":"10.1016/j.clgc.2021.11.007","key":"e_1_3_5_25_2","year":null,"issue":null,"author":null,"volume":null,"first-page":null,"unstructured":null,"article-title":null,"journal-title":null,"doi-asserted-by":"publisher"},{"DOI":"10.1200/JCO.23.01535","key":"e_1_3_5_26_2","year":null,"issue":null,"author":null,"volume":null,"first-page":null,"unstructured":null,"article-title":null,"journal-title":null,"doi-asserted-by":"publisher"},{"DOI":"10.1056/NEJMp1805966","key":"e_1_3_5_27_2","year":null,"issue":null,"author":null,"volume":null,"first-page":null,"unstructured":null,"article-title":null,"journal-title":null,"doi-asserted-by":"publisher"},{"DOI":null,"key":"e_1_3_5_28_2","year":"2021","issue":null,"author":"Administration USFaD: Guidance Document","volume":null,"first-page":null,"unstructured":"Administration USFaD: Guidance Document: Nonmetastatic Castration-Resistant Prostate Cancer: Considerations for Metastasis-Free Survival Endpoint in Clinical Trials. 2021","article-title":null,"journal-title":null,"doi-asserted-by":null},{"DOI":null,"key":"e_1_3_5_29_2","year":null,"issue":null,"author":null,"volume":null,"first-page":null,"unstructured":"Reference deleted","article-title":null,"journal-title":null,"doi-asserted-by":null},{"DOI":null,"key":"e_1_3_5_30_2","year":null,"issue":null,"author":null,"volume":null,"first-page":null,"unstructured":"Reference deleted","article-title":null,"journal-title":null,"doi-asserted-by":null},{"DOI":"10.1001/jamaoncol.2019.4636","key":"e_1_3_5_31_2","year":null,"issue":null,"author":null,"volume":null,"first-page":null,"unstructured":null,"article-title":null,"journal-title":null,"doi-asserted-by":"publisher"},{"DOI":"10.1001/jamaoncol.2021.3771","key":"e_1_3_5_32_2","year":null,"issue":null,"author":null,"volume":null,"first-page":null,"unstructured":null,"article-title":null,"journal-title":null,"doi-asserted-by":"publisher"},{"DOI":null,"key":"e_1_3_5_33_2","year":null,"issue":null,"author":null,"volume":null,"first-page":null,"unstructured":"Reference deleted","article-title":null,"journal-title":null,"doi-asserted-by":null},{"DOI":"10.1016/S1470-2045(19)30415-2","key":"e_1_3_5_34_2","year":null,"issue":null,"author":null,"volume":null,"first-page":null,"unstructured":null,"article-title":null,"journal-title":null,"doi-asserted-by":"publisher"},{"DOI":"10.1007/s00259-021-05245-y","key":"e_1_3_5_35_2","year":null,"issue":null,"author":null,"volume":null,"first-page":null,"unstructured":null,"article-title":null,"journal-title":null,"doi-asserted-by":"publisher"},{"DOI":null,"key":"e_1_3_5_36_2","year":"2022","issue":null,"author":"Gafita A","volume":"63","first-page":"1651","unstructured":"Gafita A, Rauscher I, Weber M, et al: Novel framework for treatment response evaluation using PSMA PET/CT in patients with metastatic castration-resistant prostate cancer (RECIP 1.0): An international multicenter study. J Nucl Med 63:1651-1658, 2022","article-title":"Novel framework for treatment response evaluation using PSMA PET/CT in patients with metastatic castration-resistant prostate cancer (RECIP 1.0): An international multicenter study","journal-title":"J Nucl Med","doi-asserted-by":null},{"DOI":null,"key":"e_1_3_5_37_2","year":null,"issue":null,"author":"Herrmann K","volume":null,"first-page":null,"unstructured":"Herrmann K, Walz J, MacLennan S, et al: SPARC: Standardised PSMA PET/CT analysis and reporting consensus: A Delphi analysis. Eur Urol 10.1016/j.eururo.2025.08.005 [epub ahead of print on September 13, 2025]","article-title":"SPARC: Standardised PSMA PET/CT analysis and reporting consensus: A Delphi analysis","journal-title":"Eur Urol","doi-asserted-by":null},{"DOI":"10.1186/s40644-016-0072-6","key":"e_1_3_5_38_2","year":null,"issue":null,"author":null,"volume":null,"first-page":null,"unstructured":null,"article-title":null,"journal-title":null,"doi-asserted-by":"publisher"},{"DOI":"10.2967/jnumed.121.263638","key":"e_1_3_5_39_2","year":null,"issue":null,"author":null,"volume":null,"first-page":null,"unstructured":null,"article-title":null,"journal-title":null,"doi-asserted-by":"publisher"},{"DOI":"10.1148/radiol.233460","key":"e_1_3_5_40_2","year":null,"issue":null,"author":null,"volume":null,"first-page":null,"unstructured":null,"article-title":null,"journal-title":null,"doi-asserted-by":"publisher"},{"DOI":"10.1016/S0140-6736(21)00237-3","key":"e_1_3_5_41_2","year":null,"issue":null,"author":null,"volume":null,"first-page":null,"unstructured":null,"article-title":null,"journal-title":null,"doi-asserted-by":"publisher"},{"DOI":"10.2967/jnumed.119.233817","key":"e_1_3_5_42_2","year":null,"issue":null,"author":null,"volume":null,"first-page":null,"unstructured":null,"article-title":null,"journal-title":null,"doi-asserted-by":"publisher"},{"DOI":"10.1007/s00259-020-04934-4","key":"e_1_3_5_43_2","year":null,"issue":null,"author":null,"volume":null,"first-page":null,"unstructured":null,"article-title":null,"journal-title":null,"doi-asserted-by":"publisher"},{"DOI":"10.2967/jnumed.117.198119","key":"e_1_3_5_44_2","year":null,"issue":null,"author":null,"volume":null,"first-page":null,"unstructured":null,"article-title":null,"journal-title":null,"doi-asserted-by":"publisher"},{"DOI":"10.1200/JCO-25-01693","key":"e_1_3_5_45_2","year":null,"issue":null,"author":null,"volume":null,"first-page":null,"unstructured":null,"article-title":null,"journal-title":null,"doi-asserted-by":"publisher"},{"DOI":null,"key":"e_1_3_5_46_2","year":null,"issue":null,"author":"US Food and Drug Administration","volume":null,"first-page":null,"unstructured":"US Food and Drug Administration: Project Optimus. https://www.fda.gov/about-fda/oncology-center-excellence/project-optimus","article-title":null,"journal-title":null,"doi-asserted-by":null},{"DOI":"10.1056/NEJMp2109826","key":"e_1_3_5_47_2","year":null,"issue":null,"author":null,"volume":null,"first-page":null,"unstructured":null,"article-title":null,"journal-title":null,"doi-asserted-by":"publisher"},{"DOI":null,"key":"e_1_3_5_48_2","year":"2008","issue":null,"author":"US Food and Drug Administration","volume":null,"first-page":null,"unstructured":"US Food and Drug Administration: Recommendations: Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of in Vitro Diagnostic Devices. FDA, 2008. http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm079632.htm","article-title":null,"journal-title":null,"doi-asserted-by":null},{"DOI":null,"key":"e_1_3_5_49_2","year":"2008","issue":null,"author":"Administration USFaD","volume":null,"first-page":null,"unstructured":"Administration USFaD: About Biomarkers and Qualification. 2008. https://www.fda.gov/drugs/biomarker-qualification-program/about-biomarkers-and-qualification","article-title":null,"journal-title":null,"doi-asserted-by":null},{"DOI":"10.1158/1078-0432.CCR-16-2140","key":"e_1_3_5_50_2","year":null,"issue":null,"author":null,"volume":null,"first-page":null,"unstructured":null,"article-title":null,"journal-title":null,"doi-asserted-by":"publisher"},{"DOI":"10.1158/1078-0432.CCR-15-2035","key":"e_1_3_5_51_2","year":null,"issue":null,"author":null,"volume":null,"first-page":null,"unstructured":null,"article-title":null,"journal-title":null,"doi-asserted-by":"publisher"},{"DOI":null,"key":"e_1_3_5_52_2","year":"2024","issue":null,"author":"Food and Drug Administration Center for Biologics Evaluation and Research","volume":null,"first-page":null,"unstructured":"Food and Drug Administration Center for Biologics Evaluation and Research: Guidance for Industry: Core Patient-Reported Outcomes in Cancer Clinical Trials. FDA Maryland, 2024","article-title":null,"journal-title":null,"doi-asserted-by":null},{"DOI":"10.1001/jama.2017.21903","key":"e_1_3_5_53_2","year":null,"issue":null,"author":null,"volume":null,"first-page":null,"unstructured":null,"article-title":null,"journal-title":null,"doi-asserted-by":"publisher"},{"DOI":"10.1016/S1470-2045(19)30790-9","key":"e_1_3_5_54_2","year":null,"issue":null,"author":null,"volume":null,"first-page":null,"unstructured":null,"article-title":null,"journal-title":null,"doi-asserted-by":"publisher"},{"DOI":"10.1200/JCO.21.02750","key":"e_1_3_5_55_2","year":null,"issue":null,"author":null,"volume":null,"first-page":null,"unstructured":null,"article-title":null,"journal-title":null,"doi-asserted-by":"publisher"},{"DOI":"10.1016/S1470-2045(18)30097-4","key":"e_1_3_5_56_2","year":null,"issue":null,"author":null,"volume":null,"first-page":null,"unstructured":null,"article-title":null,"journal-title":null,"doi-asserted-by":"publisher"},{"DOI":"10.1200/JCO.2017.72.2348","key":"e_1_3_5_57_2","year":null,"issue":null,"author":null,"volume":null,"first-page":null,"unstructured":null,"article-title":null,"journal-title":null,"doi-asserted-by":"publisher"},{"DOI":"10.2967/jnumed.116.181800","key":"e_1_3_5_58_2","year":null,"issue":null,"author":null,"volume":null,"first-page":null,"unstructured":null,"article-title":null,"journal-title":null,"doi-asserted-by":"publisher"},{"DOI":"10.1016/j.clgc.2022.02.002","key":"e_1_3_5_59_2","year":null,"issue":null,"author":null,"volume":null,"first-page":null,"unstructured":null,"article-title":null,"journal-title":null,"doi-asserted-by":"publisher"},{"DOI":"10.1200/JCO.2017.73.9987","key":"e_1_3_5_60_2","year":null,"issue":null,"author":null,"volume":null,"first-page":null,"unstructured":null,"article-title":null,"journal-title":null,"doi-asserted-by":"publisher"},{"DOI":"10.1056/NEJMoa1715546","key":"e_1_3_5_61_2","year":null,"issue":null,"author":null,"volume":null,"first-page":null,"unstructured":null,"article-title":null,"journal-title":null,"doi-asserted-by":"publisher"},{"DOI":"10.1056/NEJMoa1800536","key":"e_1_3_5_62_2","year":null,"issue":null,"author":null,"volume":null,"first-page":null,"unstructured":null,"article-title":null,"journal-title":null,"doi-asserted-by":"publisher"},{"DOI":"10.1056/NEJMoa1815671","key":"e_1_3_5_63_2","year":null,"issue":null,"author":null,"volume":null,"first-page":null,"unstructured":null,"article-title":null,"journal-title":null,"doi-asserted-by":"publisher"},{"DOI":"10.1016/j.eururo.2024.09.017","key":"e_1_3_5_64_2","year":null,"issue":null,"author":null,"volume":null,"first-page":null,"unstructured":null,"article-title":null,"journal-title":null,"doi-asserted-by":"publisher"},{"DOI":"10.1200/JCO.23.00985","key":"e_1_3_5_65_2","year":null,"issue":null,"author":null,"volume":null,"first-page":null,"unstructured":null,"article-title":null,"journal-title":null,"doi-asserted-by":"publisher"},{"DOI":"10.1200/JCO.2007.12.4487","key":"e_1_3_5_66_2","year":null,"issue":null,"author":null,"volume":null,"first-page":null,"unstructured":null,"article-title":null,"journal-title":null,"doi-asserted-by":"publisher"},{"DOI":"10.1038/pcan.2016.71","key":"e_1_3_5_67_2","year":null,"issue":null,"author":null,"volume":null,"first-page":null,"unstructured":null,"article-title":null,"journal-title":null,"doi-asserted-by":"publisher"},{"DOI":"10.1002/cncr.30587","key":"e_1_3_5_68_2","year":null,"issue":null,"author":null,"volume":null,"first-page":null,"unstructured":null,"article-title":null,"journal-title":null,"doi-asserted-by":"publisher"},{"DOI":"10.1200/JCO.2022.40.16_suppl.5072","key":"e_1_3_5_69_2","year":null,"issue":null,"author":null,"volume":null,"first-page":null,"unstructured":null,"article-title":null,"journal-title":null,"doi-asserted-by":"publisher"},{"DOI":null,"key":"e_1_3_5_70_2","year":null,"issue":null,"author":null,"volume":null,"first-page":null,"unstructured":"Armstrong A Azad A Iguchi T et al: Radiographic progression with and without prostate-specific antigen rise in patients with advanced prostate cancer treated with enzalutamide. J Clin Oncol (in press)","article-title":null,"journal-title":null,"doi-asserted-by":null},{"DOI":"10.5858/2000-124-1608-RPTMIS","key":"e_1_3_5_71_2","year":null,"issue":null,"author":null,"volume":null,"first-page":null,"unstructured":null,"article-title":null,"journal-title":null,"doi-asserted-by":"publisher"}],"short-title":[],"journal-issue":{"issue":"13","published-print":{"date-parts":[[2026,5,1]]}},"update-policy":"https://doi.org/10.1200/crossmark","alternative-id":["10.1200/JCO-25-02834"],"content-domain":{"domain":["ascopubs.org"],"crossmark-restriction":true},"original-title":[],"container-title":["Journal of Clinical Oncology"],"published-print":{"date-parts":[[2026,5,1]]},"reference-count":70,"published-online":null,"references-count":70,"short-container-title":["J Clin Oncol"],"is-referenced-by-count":3},"unpaywall":{"doi":"10.1200/jco-25-02834","is_oa":true,"title":"Trial Design and Objectives for Patients With Prostate Cancer: Recommendations From the Prostate Cancer Working Group 4","updated":"2026-05-04T08:56:22+00:00","published_date":"2026-02-26","best_oa_location":{"url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC13132095/","pmh_id":"oai:pubmedcentral.nih.gov:13132095","url_for_pdf":null,"url_for_landing_page":"https://pmc.ncbi.nlm.nih.gov/articles/PMC13132095/"}}},"created_at":"2026-05-07T22:51:18.787Z","updated_at":"2026-05-14T15:13:26.918Z","tags":[{"paper_doi":"10.1200/jco-25-02834","tag_type":"age_group","value":"adult","value_numeric":null},{"paper_doi":"10.1200/jco-25-02834","tag_type":"brand","value":"Erleada","value_numeric":null},{"paper_doi":"10.1200/jco-25-02834","tag_type":"brand","value":"Lynparza","value_numeric":null},{"paper_doi":"10.1200/jco-25-02834","tag_type":"brand","value":"Nubeqa","value_numeric":null},{"paper_doi":"10.1200/jco-25-02834","tag_type":"brand","value":"Pluvicto","value_numeric":null},{"paper_doi":"10.1200/jco-25-02834","tag_type":"brand","value":"Xtandi","value_numeric":null},{"paper_doi":"10.1200/jco-25-02834","tag_type":"category","value":"Oncology","value_numeric":null},{"paper_doi":"10.1200/jco-25-02834","tag_type":"condition","value":"Metastatic Castration-Resistant Prostate Cancer","value_numeric":null},{"paper_doi":"10.1200/jco-25-02834","tag_type":"condition","value":"Prostate Cancer","value_numeric":null},{"paper_doi":"10.1200/jco-25-02834","tag_type":"generic","value":"abiraterone","value_numeric":null},{"paper_doi":"10.1200/jco-25-02834","tag_type":"generic","value":"apalutamide","value_numeric":null},{"paper_doi":"10.1200/jco-25-02834","tag_type":"generic","value":"darolutamide","value_numeric":null},{"paper_doi":"10.1200/jco-25-02834","tag_type":"generic","value":"enzalutamide","value_numeric":null},{"paper_doi":"10.1200/jco-25-02834","tag_type":"generic","value":"lutetium-177 PSMA-617","value_numeric":null},{"paper_doi":"10.1200/jco-25-02834","tag_type":"generic","value":"olaparib","value_numeric":null},{"paper_doi":"10.1200/jco-25-02834","tag_type":"impact_flag","value":"practice_changing","value_numeric":null},{"paper_doi":"10.1200/jco-25-02834","tag_type":"level_of_evidence","value":"5","value_numeric":null},{"paper_doi":"10.1200/jco-25-02834","tag_type":"modality","value":"Androgen Deprivation Therapy","value_numeric":null},{"paper_doi":"10.1200/jco-25-02834","tag_type":"modality","value":"Androgen Receptor Pathway Inhibitor","value_numeric":null},{"paper_doi":"10.1200/jco-25-02834","tag_type":"modality","value":"Lutetium-177 PSMA Therapy","value_numeric":null},{"paper_doi":"10.1200/jco-25-02834","tag_type":"modality","value":"PARP Inhibitor","value_numeric":null},{"paper_doi":"10.1200/jco-25-02834","tag_type":"modality","value":"PSMA-PET Imaging","value_numeric":null},{"paper_doi":"10.1200/jco-25-02834","tag_type":"sex","value":"male","value_numeric":null},{"paper_doi":"10.1200/jco-25-02834","tag_type":"study_design","value":"Clinical Practice Guideline / Expert Consensus","value_numeric":null},{"paper_doi":"10.1200/jco-25-02834","tag_type":"warning","value":"Many PSMA-PET-based response and progression criteria proposed by PCWG4 are explicitly labeled investigational and require prospective phase III validation before clinical or regulatory use.","value_numeric":null},{"paper_doi":"10.1200/jco-25-02834","tag_type":"warning","value":"Sample size tag omitted — this is a working group consensus document with no enrolled patient cohort.","value_numeric":null},{"paper_doi":"10.1200/jco-25-02834","tag_type":"warning","value":"The impact_flag 'practice_changing' applies specifically to clinical trial design and terminology standards, not to direct patient treatment decisions outside of trials.","value_numeric":null},{"paper_doi":"10.1200/jco-25-02834","tag_type":"warning","value":"This is a consensus/guideline article, not a primary efficacy or safety trial — no patient-level outcomes data are reported; 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; and (5) defining PSA progression in the APM setting as any confirmed rise ≥0.2 ng/mL from baseline/nadir on two measurements ≥21 days apart.","limitations":"This is a consensus guideline document, not a primary clinical trial — recommendations are expert-based and many proposed PSMA-PET criteria (e.g., SUV-based response, PET-defined rPFS) require prospective phase III validation. The document acknowledges that most novel biomarkers (ctDNA, CTC0, PSA declines) are not yet validated surrogates for OS or regulatory approval.","practice_takeaway":"Clinicians designing or interpreting prostate cancer trials should adopt APMN/APMS/APMR terminology and obtain PSMA-PET at baseline where feasible, while tracking CT/bone scan findings independently. For bone progression on bone scintigraphy or PSMA-PET, a confirmatory scan is no longer required when ≥6 new lesions are seen — act on that finding promptly rather than waiting."}}],"initialOffset":2,"fetchConfig":{"kind":"tags","tags":[{"tag_type":"generic","value":"lutetium-177 PSMA-617"}]},"breadcrumbItems":[{"name":"Home","href":"/"},{"name":"Research Hub","href":"/hub"},{"name":"Generics","href":"/hub/tag/generic"},{"name":"lutetium-177 PSMA-617"}],"hrefConfig":{"basePath":"/hub/papers","webViewQueryParams":{"hub_ctx":"tag","hub_tag_type":"generic","hub_tag_value":"lutetium-177 PSMA-617"}}}]]

Papers