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\":\"darolutamide: generic Research & Clinical Takeaways\",\"description\":\"Explore peer-reviewed papers on darolutamide (generic). Clinician-written summaries and actionable practice insights. 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Median PFS was 8.5 months (95% CI: 3.1–12.0 months); median OS was not reached. No grade 4 or 5 adverse events were attributed to treatment. The trial did not advance to stage 2.","limitations":"- Very small sample size (n=16 evaluable) limits generalizability.\n- Single-arm design with no comparator group makes it difficult to attribute PFS benefit to treatment.\n- Accrual was completed in just 3 months, raising questions about patient selection at participating sites.","practice_takeaway":"This triplet hormonal regimen did not meet its prespecified ORR threshold in AI-pretreated recurrent AGCT and cannot be recommended as a standard approach. However, the disease control rate (62.5% stable disease) and 8.5-month median PFS may still inform future combination strategies for this rare tumor."}},{"doi":"10.1002/cncr.70494","pmid":"42572469","title":"How low do you need to go? Association between various prostate‐specific antigen response measures and clinical outcomes in metastatic castration‐sensitive prostate cancer in the Veterans Health Administration data","journal_title":"Cancer","journal_issn":"0008-543X","published_at":"2026-08-10T00:00:00.000Z","url":"https://pubmed.ncbi.nlm.nih.gov/42572469/","source_score":55,"is_retracted":false,"is_open_access":true,"raw_metadata":{"pubmed":true,"crossref":true,"unpaywall":true},"created_at":"2026-08-17T13:33:07.267Z","updated_at":"2026-08-17T13:33:07.267Z","tags":[{"paper_doi":"10.1002/cncr.70494","tag_type":"age_group","value":"older_adult","value_numeric":null},{"paper_doi":"10.1002/cncr.70494","tag_type":"brand","value":"Erleada","value_numeric":null},{"paper_doi":"10.1002/cncr.70494","tag_type":"brand","value":"Nubeqa","value_numeric":null},{"paper_doi":"10.1002/cncr.70494","tag_type":"brand","value":"Xtandi","value_numeric":null},{"paper_doi":"10.1002/cncr.70494","tag_type":"brand","value":"Zytiga","value_numeric":null},{"paper_doi":"10.1002/cncr.70494","tag_type":"category","value":"Oncology","value_numeric":null},{"paper_doi":"10.1002/cncr.70494","tag_type":"condition","value":"Metastatic Castration-Sensitive Prostate Cancer","value_numeric":null},{"paper_doi":"10.1002/cncr.70494","tag_type":"generic","value":"abiraterone","value_numeric":null},{"paper_doi":"10.1002/cncr.70494","tag_type":"generic","value":"apalutamide","value_numeric":null},{"paper_doi":"10.1002/cncr.70494","tag_type":"generic","value":"darolutamide","value_numeric":null},{"paper_doi":"10.1002/cncr.70494","tag_type":"generic","value":"docetaxel","value_numeric":null},{"paper_doi":"10.1002/cncr.70494","tag_type":"generic","value":"enzalutamide","value_numeric":null},{"paper_doi":"10.1002/cncr.70494","tag_type":"impact_flag","value":"practice_changing","value_numeric":null},{"paper_doi":"10.1002/cncr.70494","tag_type":"level_of_evidence","value":"3","value_numeric":null},{"paper_doi":"10.1002/cncr.70494","tag_type":"modality","value":"Androgen Deprivation Therapy","value_numeric":null},{"paper_doi":"10.1002/cncr.70494","tag_type":"modality","value":"Androgen Receptor Pathway Inhibitor","value_numeric":null},{"paper_doi":"10.1002/cncr.70494","tag_type":"sample_size","value":"n=4890","value_numeric":4890},{"paper_doi":"10.1002/cncr.70494","tag_type":"sex","value":"male","value_numeric":null},{"paper_doi":"10.1002/cncr.70494","tag_type":"study_design","value":"Retrospective Cohort Study","value_numeric":null},{"paper_doi":"10.1002/cncr.70494","tag_type":"warning","value":"Generalizability is limited: the VHA population is predominantly older, male, and includes a high proportion of Black patients (29%), which may not reflect the broader mCSPC population.","value_numeric":null},{"paper_doi":"10.1002/cncr.70494","tag_type":"warning","value":"Impact flag 'practice_changing' applied because PSA <0.2 ng/mL as the target metric directly contradicts the majority of current real-world physician practice (85% use % decline), though this is a retrospective observational study and causality cannot be established.","value_numeric":null},{"paper_doi":"10.1002/cncr.70494","tag_type":"warning","value":"Plain language summary states data from 2018–2023 for index dates, while the methods section states VHA data from 2006–2024 — the broader date range reflects data availability, with index dates restricted to 2018–2023.","value_numeric":null},{"paper_doi":"10.1002/cncr.70494","tag_type":"warning","value":"Study sponsored by Pfizer and Astellas (codevelopers of enzalutamide); several authors are employees or shareholders of these companies — potential for sponsorship bias.","value_numeric":null}],"summaries":{"what_studied":"This retrospective cohort study used Veterans Health Administration data (2006–2024, index dates 2018–2023) to compare two PSA-response metrics — PSA nadir <0.2 ng/mL vs. ≥90% PSA decline within 9 months of ADT initiation — and their association with overall survival (OS) and disease progression in 4,890 men with mCSPC receiving ADT ± ARPIs, NSAAs, or docetaxel.","key_result":"Achieving PSA <0.2 ng/mL within 9 months was associated with a 54% lower risk of death (adjusted HR 0.46; 95% CI 0.40–0.54) and a 55% lower risk of disease progression (adjusted HR 0.45; 95% CI 0.40–0.50) vs. not achieving it; 3-year OS was ~78–83% vs. ~48–51%. In contrast, ≥90% PSA decline alone (without reaching <0.2 ng/mL) was not associated with improved OS or disease progression. ADT + ARPI nearly doubled the rate of achieving PSA <0.2 ng/mL vs. ADT alone (OR 2.36; 95% CI 1.97–2.83).","limitations":"- Retrospective VHA cohort; findings may not generalize beyond a predominantly older male veteran population.\n- Key confounders (tumor grade, disease volume) were unavailable in the administrative dataset.\n- Testosterone levels were not used to define castration sensitivity, and administrative coding inaccuracies may affect cohort classification.","practice_takeaway":"Clinicians should target a PSA nadir <0.2 ng/mL — not just ≥90% PSA decline — when assessing treatment response in mCSPC, as only the absolute threshold predicts improved survival and delayed progression. Adding an ARPI to ADT more than doubles the odds of reaching this target and should be considered the standard approach."}},{"doi":"10.1007/s11523-026-01234-z","pmid":"42568016","title":"Impact of PSA Nadir on Outcomes in Metastatic Hormone-Sensitive Prostate Cancer: A Systematic Review and Reconstructed Individual Patient Data Meta-analysis","journal_title":"Targeted Oncology","journal_issn":"1776-2596","published_at":"2026-08-07T00:00:00.000Z","url":"https://doi.org/10.1007/s11523-026-01234-z","source_score":22,"is_retracted":false,"is_open_access":true,"raw_metadata":{"pubmed":true,"crossref":true,"unpaywall":true},"created_at":"2026-08-12T13:26:14.862Z","updated_at":"2026-08-12T13:26:14.862Z","tags":[{"paper_doi":"10.1007/s11523-026-01234-z","tag_type":"age_group","value":"adult","value_numeric":null},{"paper_doi":"10.1007/s11523-026-01234-z","tag_type":"category","value":"Oncology","value_numeric":null},{"paper_doi":"10.1007/s11523-026-01234-z","tag_type":"condition","value":"Metastatic Hormone-Sensitive Prostate Cancer","value_numeric":null},{"paper_doi":"10.1007/s11523-026-01234-z","tag_type":"condition","value":"Prostate Cancer","value_numeric":null},{"paper_doi":"10.1007/s11523-026-01234-z","tag_type":"generic","value":"abiraterone","value_numeric":null},{"paper_doi":"10.1007/s11523-026-01234-z","tag_type":"generic","value":"apalutamide","value_numeric":null},{"paper_doi":"10.1007/s11523-026-01234-z","tag_type":"generic","value":"darolutamide","value_numeric":null},{"paper_doi":"10.1007/s11523-026-01234-z","tag_type":"generic","value":"docetaxel","value_numeric":null},{"paper_doi":"10.1007/s11523-026-01234-z","tag_type":"generic","value":"enzalutamide","value_numeric":null},{"paper_doi":"10.1007/s11523-026-01234-z","tag_type":"impact_flag","value":"confirms_prior","value_numeric":null},{"paper_doi":"10.1007/s11523-026-01234-z","tag_type":"level_of_evidence","value":"2","value_numeric":null},{"paper_doi":"10.1007/s11523-026-01234-z","tag_type":"modality","value":"Androgen Receptor Pathway Inhibitor","value_numeric":null},{"paper_doi":"10.1007/s11523-026-01234-z","tag_type":"modality","value":"Chemotherapy","value_numeric":null},{"paper_doi":"10.1007/s11523-026-01234-z","tag_type":"sample_size","value":"n=1638","value_numeric":1638},{"paper_doi":"10.1007/s11523-026-01234-z","tag_type":"sex","value":"male","value_numeric":null},{"paper_doi":"10.1007/s11523-026-01234-z","tag_type":"study_design","value":"Systematic Review and Meta-Analysis","value_numeric":null},{"paper_doi":"10.1007/s11523-026-01234-z","tag_type":"warning","value":"IPD was reconstructed from published Kaplan-Meier curves using software (IPDfromKM), not sourced directly from trial databases—minor inaccuracies in patient-level data are possible, as noted in the supplementary table comparisons.","value_numeric":null},{"paper_doi":"10.1007/s11523-026-01234-z","tag_type":"warning","value":"The meta-analysis did not register a protocol or perform a GRADE certainty-of-evidence assessment, limiting confidence in the strength of recommendations.","value_numeric":null},{"paper_doi":"10.1007/s11523-026-01234-z","tag_type":"warning","value":"The OS analysis includes 1,638 patients while the PFS analysis includes only 1,104 patients—not all studies contributed to both endpoints, which should be considered when interpreting results.","value_numeric":null},{"paper_doi":"10.1007/s11523-026-01234-z","tag_type":"warning","value":"The PSA nadir cutoff varied across included studies (some used ≤0.1 ng/mL, others ≤0.2 ng/mL); the pooled analysis used ≤0.2 as the primary threshold, which may affect comparability.","value_numeric":null}],"summaries":{"what_studied":"This reconstructed individual patient data (IPD) meta-analysis of 8 studies evaluated the prognostic value of PSA nadir (≤0.2 vs. >0.2 ng/mL) on overall survival (OS) and progression-free survival (PFS) in patients with metastatic hormone-sensitive prostate cancer (mHSPC) treated with androgen receptor pathway inhibitors (ARPIs) or docetaxel.","key_result":"Achieving a PSA nadir ≤0.2 ng/mL was strongly associated with better outcomes: median PFS not reached vs. 12.1 months (HR 0.19, 95% CI 0.16–0.23, p<0.0001) and median OS 92.8 vs. 34 months (HR 0.27, 95% CI 0.22–0.33, p<0.0001), across 1,638 patients (OS) and 1,104 patients (PFS).","limitations":"- IPD was reconstructed from Kaplan-Meier curves rather than obtained directly from trial investigators, introducing potential reconstruction error.\n- The PSA nadir threshold of ≤0.2 ng/mL was not uniform across all included studies (some used ≤0.1), creating heterogeneity in the defining cutpoint.\n- No formal certainty-of-evidence (e.g., GRADE) assessment was conducted, and reporting bias assessment was not performed.","practice_takeaway":"In mHSPC patients on ARPIs or docetaxel, achieving a PSA nadir ≤0.2 ng/mL is a strong early marker of favorable prognosis—clinicians can use this threshold to flag patients at high risk of early progression and inform closer monitoring or discussion of treatment intensification."}},{"doi":"10.1038/s41391-026-01131-6","pmid":"42323390","title":"Efficacy and safety of darolutamide plus androgen-deprivation therapy in Black patients with metastatic hormone-sensitive prostate cancer from the phase 3 ARANOTE trial","journal_title":"Prostate Cancer and Prostatic Diseases","journal_issn":"1365-7852","published_at":"2026-06-20T00:00:00.000Z","url":"https://doi.org/10.1038/s41391-026-01131-6","source_score":9,"is_retracted":false,"is_open_access":true,"raw_metadata":{"pubmed":true,"crossref":true,"unpaywall":true},"created_at":"2026-06-24T13:21:37.952Z","updated_at":"2026-06-24T13:21:37.952Z","tags":[{"paper_doi":"10.1038/s41391-026-01131-6","tag_type":"age_group","value":"adult","value_numeric":null},{"paper_doi":"10.1038/s41391-026-01131-6","tag_type":"brand","value":"Nubeqa","value_numeric":null},{"paper_doi":"10.1038/s41391-026-01131-6","tag_type":"category","value":"Urology & Nephrology","value_numeric":null},{"paper_doi":"10.1038/s41391-026-01131-6","tag_type":"condition","value":"Metastatic Hormone-Sensitive Prostate Cancer","value_numeric":null},{"paper_doi":"10.1038/s41391-026-01131-6","tag_type":"generic","value":"darolutamide","value_numeric":null},{"paper_doi":"10.1038/s41391-026-01131-6","tag_type":"impact_flag","value":"confirms_prior","value_numeric":null},{"paper_doi":"10.1038/s41391-026-01131-6","tag_type":"level_of_evidence","value":"2","value_numeric":null},{"paper_doi":"10.1038/s41391-026-01131-6","tag_type":"modality","value":"Androgen Deprivation Therapy","value_numeric":null},{"paper_doi":"10.1038/s41391-026-01131-6","tag_type":"modality","value":"Androgen Receptor Inhibitor","value_numeric":null},{"paper_doi":"10.1038/s41391-026-01131-6","tag_type":"sample_size","value":"n=65","value_numeric":65},{"paper_doi":"10.1038/s41391-026-01131-6","tag_type":"sex","value":"male","value_numeric":null},{"paper_doi":"10.1038/s41391-026-01131-6","tag_type":"study_design","value":"Subgroup Analysis of Randomized Controlled Trial","value_numeric":null},{"paper_doi":"10.1038/s41391-026-01131-6","tag_type":"warning","value":"Full safety data and secondary endpoints (e.g., overall survival, PSA response) were not reported in the available abstract text.","value_numeric":null},{"paper_doi":"10.1038/s41391-026-01131-6","tag_type":"warning","value":"Level of evidence assigned as '2' reflects the RCT source trial; the subgroup analysis itself carries inherently lower certainty.","value_numeric":null},{"paper_doi":"10.1038/s41391-026-01131-6","tag_type":"warning","value":"This is a subgroup analysis of only 65 Black patients (10% of the total trial), so the 49% rPFS risk reduction should be interpreted with caution due to limited statistical power.","value_numeric":null}],"summaries":{"what_studied":"This pre-specified subgroup analysis of the phase 3 ARANOTE trial evaluated darolutamide 600 mg twice daily plus ADT vs. placebo plus ADT in Black patients (n=65) with metastatic hormone-sensitive prostate cancer.","key_result":"In Black patients, darolutamide + ADT reduced the risk of radiological progression or death by 49% vs. ADT alone (rPFS benefit), consistent with the overall ARANOTE population (N=669).","limitations":"Small subgroup (n=65; only 10% of total trial population), limiting statistical power. Safety data detail is sparse in the abstract. No overall survival or PSA response data reported in the available text.","practice_takeaway":"Darolutamide + ADT appears to offer meaningful rPFS benefit in Black patients with metastatic hormone-sensitive prostate cancer, a historically underrepresented group in clinical trials. Clinicians can apply these findings with cautious confidence given consistency with the overall trial result."}},{"doi":"10.1038/s41391-026-01124-5","pmid":"42209844","title":"EMETPRO: a multicentric, international, retrospective analysis evaluating patients with metastatic hormone-sensitive prostate cancer with early progression","journal_title":"Prostate Cancer and Prostatic Diseases","journal_issn":"1365-7852","published_at":"2026-05-29T00:00:00.000Z","url":"https://doi.org/10.1038/s41391-026-01124-5","source_score":1,"is_retracted":false,"is_open_access":false,"raw_metadata":{"pubmed":true,"crossref":true,"unpaywall":true},"created_at":"2026-06-08T13:46:34.969Z","updated_at":"2026-06-08T13:46:34.969Z","tags":[{"paper_doi":"10.1038/s41391-026-01124-5","tag_type":"age_group","value":"adult","value_numeric":null},{"paper_doi":"10.1038/s41391-026-01124-5","tag_type":"category","value":"Urology & Nephrology","value_numeric":null},{"paper_doi":"10.1038/s41391-026-01124-5","tag_type":"condition","value":"Metastatic Castration-Resistant Prostate Cancer","value_numeric":null},{"paper_doi":"10.1038/s41391-026-01124-5","tag_type":"condition","value":"Metastatic Hormone-Sensitive Prostate Cancer","value_numeric":null},{"paper_doi":"10.1038/s41391-026-01124-5","tag_type":"generic","value":"abiraterone","value_numeric":null},{"paper_doi":"10.1038/s41391-026-01124-5","tag_type":"generic","value":"apalutamide","value_numeric":null},{"paper_doi":"10.1038/s41391-026-01124-5","tag_type":"generic","value":"darolutamide","value_numeric":null},{"paper_doi":"10.1038/s41391-026-01124-5","tag_type":"generic","value":"docetaxel","value_numeric":null},{"paper_doi":"10.1038/s41391-026-01124-5","tag_type":"generic","value":"enzalutamide","value_numeric":null},{"paper_doi":"10.1038/s41391-026-01124-5","tag_type":"impact_flag","value":"limited_evidence","value_numeric":null},{"paper_doi":"10.1038/s41391-026-01124-5","tag_type":"level_of_evidence","value":"4","value_numeric":null},{"paper_doi":"10.1038/s41391-026-01124-5","tag_type":"modality","value":"Androgen Deprivation Therapy","value_numeric":null},{"paper_doi":"10.1038/s41391-026-01124-5","tag_type":"modality","value":"Androgen Receptor Pathway Inhibitor","value_numeric":null},{"paper_doi":"10.1038/s41391-026-01124-5","tag_type":"modality","value":"Taxane Chemotherapy","value_numeric":null},{"paper_doi":"10.1038/s41391-026-01124-5","tag_type":"sample_size","value":"n=401","value_numeric":401},{"paper_doi":"10.1038/s41391-026-01124-5","tag_type":"sex","value":"male","value_numeric":null},{"paper_doi":"10.1038/s41391-026-01124-5","tag_type":"study_design","value":"Retrospective Multicenter Registry Study","value_numeric":null},{"paper_doi":"10.1038/s41391-026-01124-5","tag_type":"warning","value":"Specific ARPIs used are not broken down in the available abstract/results text; brand and generic tags reflect agents mentioned in the reference list and background context rather than confirmed per-patient data.","value_numeric":null},{"paper_doi":"10.1038/s41391-026-01124-5","tag_type":"warning","value":"The level of evidence is rated 4 given the retrospective, non-randomized, registry design.","value_numeric":null},{"paper_doi":"10.1038/s41391-026-01124-5","tag_type":"warning","value":"The study spans 2005–2023, meaning a substantial proportion of patients were treated before combination therapy (ARPI+ADT) became standard, which may confound comparisons between treatment groups.","value_numeric":null},{"paper_doi":"10.1038/s41391-026-01124-5","tag_type":"warning","value":"The total sample size of 401 is inferred by summing the three reported subgroups (201 + 124 + 76); the abstract does not explicitly state the total N.","value_numeric":null}],"summaries":{"practice_takeaway":"Patients with early progression on mHSPC therapy face very poor survival (median OS under 27 months) regardless of the subsequent mCRPC treatment used — no clear best next step has emerged. Clinicians should consider enrolling these patients in clinical trials, as optimal first-line mCRPC therapy remains an unmet need.","what_studied":"This multicentric retrospective registry (EMETPRO) evaluated 401 patients with metastatic hormone-sensitive prostate cancer (mHSPC) who had early progression (EP): ≤6 months on ADT+docetaxel or ADT+ARPI, or ≤9 months on ADT monotherapy, treated between 2005 and 2023 across international centers.","key_result":"Outcomes were poor across all groups. ADT monotherapy patients had median PFS 6.8 months and median OS 26.4 months. ADT+docetaxel patients had median PFS 4.9 months and OS 18.6 months. ADT+ARPI patients had median PFS 5.6 months and OS 19.5 months. Neither first-line mCRPC treatment choice nor genetic profile was associated with improved survival.","limitations":"Retrospective design with data spanning 2005–2023 introduces heterogeneity in treatment eras and standards. Genetic profiling was not available for all patients, limiting biomarker analysis. No randomization; treatment allocation was at physician discretion."}},{"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 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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; 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":7,"fetchConfig":{"kind":"tags","tags":[{"tag_type":"generic","value":"darolutamide"}]},"breadcrumbItems":[{"name":"Home","href":"/"},{"name":"Research Hub","href":"/hub"},{"name":"Generics","href":"/hub/tag/generic"},{"name":"darolutamide"}],"hrefConfig":{"basePath":"/hub/papers","webViewQueryParams":{"hub_ctx":"tag","hub_tag_type":"generic","hub_tag_value":"darolutamide"}}}]]

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