2f:I[703058,["/_next/static/immutable/chunks/3bhq_5eh1d760.js","/_next/static/immutable/chunks/1855-ogyi8eh4.js","/_next/static/immutable/chunks/2pfsjpn6k6zlg.js","/_next/static/immutable/chunks/26c7v3_3uwnwu.js","/_next/static/immutable/chunks/25a3ozcrvi1ff.js","/_next/static/immutable/chunks/2r4wx50nvjh_4.js","/_next/static/immutable/chunks/23fsw06hsi5b1.js","/_next/static/immutable/chunks/06_yt270h41rg.js","/_next/static/immutable/chunks/3ezsiz-7shkna.js","/_next/static/immutable/chunks/20x2y96ldu5wx.js","/_next/static/immutable/chunks/2lxntcm3pd1_h.js","/_next/static/immutable/chunks/00dgco8irq3jw.js","/_next/static/immutable/chunks/00nwe-kq0rboc.js","/_next/static/immutable/chunks/2051ffx3xzio9.js"],"PaperListPageClient"] 30:T780,The continuous development of new imaging approaches, molecular phenotyping, genetic subtypes, prognosis assessments, and effective therapies across a range of disease states has created a need to redefine terminology and best practices for clinical trial conduct in patients with advanced prostate cancer. We convened an international expert committee of diverse working groups, the Prostate Cancer Working Group 4 (PCWG4), between 2016 and 2025. Our objective was to formulate updated criteria based on emerging evidence and clinical trial data in a biomarker context to provide guidance for clinical trial design, eligibility, and end point assessments for patients with advanced prostate cancer. PCWG4 redefines terminology around the disease state and previous therapies in a patient-centric context and terminology focused on androgen pathway modulation. We consider imaging, with a particular focus on positron emission tomography (PET)-defined disease. New recommendations are provided for disease state terminology, defining eligibility criteria, response and delay/prevent end points, intervals for reassessments including imaging, and patient-reported outcome determination. We provide recommendations in a biomarker-based context of use for the intended indication, reflective of patient benefit for specific interventions. We emphasize the need for development of validated PET imaging and molecular and phenotypic criteria as well as trial designs to appropriately risk stratify patients, predict and assess benefit, and measure post-treatment outcomes reliably in a trial framework. PCWG4 updates recommendations on patient and tumor characterization, therapy development, and imaging criteria and extends guidance into earlier androgen pathway modulator-naïve/sensitive disease states to reflect an evolving, heterogeneous, and diverse patient population to optimize treatment benefits for all patients.31:T9c9, PURPOSE The continuous development of new imaging approaches, molecular phenotyping, genetic subtypes, prognosis assessments, and effective therapies across a range of disease states has created a need to redefine terminology and best practices for clinical trial conduct in patients with advanced prostate cancer. METHODS We convened an international expert committee of diverse working groups, the Prostate Cancer Working Group 4 (PCWG4), between 2016 and 2025. Our objective was to formulate updated criteria based on emerging evidence and clinical trial data in a biomarker context to provide guidance for clinical trial design, eligibility, and end point assessments for patients with advanced prostate cancer. RESULTS PCWG4 redefines terminology around the disease state and previous therapies in a patient-centric context and terminology focused on androgen pathway modulation. We consider imaging, with a particular focus on positron emission tomography (PET)–defined disease. New recommendations are provided for disease state terminology, defining eligibility criteria, response and delay/prevent end points, intervals for reassessments including imaging, and patient-reported outcome determination. We provide recommendations in a biomarker-based context of use for the intended indication, reflective of patient benefit for specific interventions. We emphasize the need for development of validated PET imaging and molecular and phenotypic criteria as well as trial designs to appropriately risk stratify patients, predict and assess benefit, and measure post-treatment outcomes reliably in a trial framework. CONCLUSION PCWG4 updates recommendations on patient and tumor characterization, therapy development, and imaging criteria and extends guidance into earlier androgen pathway modulator–naïve/sensitive disease states to reflect an evolving, heterogeneous, and diverse patient population to optimize treatment benefits for all patients. 25:[[["$","script","0",{"type":"application/ld+json","dangerouslySetInnerHTML":{"__html":"{\"@context\":\"https://schema.org\",\"@type\":\"CollectionPage\",\"name\":\"Metastatic Castration-Resistant Prostate Cancer: condition Research & Clinical Takeaways\",\"description\":\"Explore peer-reviewed papers on Metastatic Castration-Resistant Prostate Cancer (condition). 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Confirmed PSA-90 response was 50.5% vs 34.1% (p=0.001), with median time to PSA-90 response of 5.6 vs 22.1 months (HR 1.48, p=0.004).","limitations":"- Exploratory post hoc design limits causal inference.\n- No multiplicity adjustment increases risk of false-positive findings.\n- No analysis linking biomarker responses (ALP, PSA) to clinical outcomes such as survival.","practice_takeaway":"Adding radium-223 to enzalutamide produces faster and deeper ALP and PSA responses in mCRPC with bone metastases, suggesting meaningful added antitumour activity. Clinicians should note these are biomarker endpoints without confirmed links to survival benefit in this analysis."}},{"doi":"10.1016/j.euo.2026.07.014","pmid":"42595654","title":"Efficacy of Olaparib Plus Abiraterone for Patients with Metastatic Castration-resistant Prostate Cancer and Single Homologous Recombination Repair Gene Mutations in PROpel","journal_title":"European Urology Oncology","journal_issn":"2588-9311","published_at":"2026-08-13T00:00:00.000Z","url":"https://doi.org/10.1016/j.euo.2026.07.014","source_score":15,"is_retracted":false,"is_open_access":true,"raw_metadata":{"pubmed":true,"crossref":true,"unpaywall":true},"created_at":"2026-08-17T13:33:11.214Z","updated_at":"2026-08-17T13:33:11.214Z","tags":[{"paper_doi":"10.1016/j.euo.2026.07.014","tag_type":"age_group","value":"adult","value_numeric":null},{"paper_doi":"10.1016/j.euo.2026.07.014","tag_type":"brand","value":"Lynparza","value_numeric":null},{"paper_doi":"10.1016/j.euo.2026.07.014","tag_type":"brand","value":"Zytiga","value_numeric":null},{"paper_doi":"10.1016/j.euo.2026.07.014","tag_type":"category","value":"Urology & Nephrology","value_numeric":null},{"paper_doi":"10.1016/j.euo.2026.07.014","tag_type":"condition","value":"Metastatic Castration-Resistant Prostate Cancer","value_numeric":null},{"paper_doi":"10.1016/j.euo.2026.07.014","tag_type":"generic","value":"abiraterone","value_numeric":null},{"paper_doi":"10.1016/j.euo.2026.07.014","tag_type":"generic","value":"olaparib","value_numeric":null},{"paper_doi":"10.1016/j.euo.2026.07.014","tag_type":"impact_flag","value":"practice_changing","value_numeric":null},{"paper_doi":"10.1016/j.euo.2026.07.014","tag_type":"level_of_evidence","value":"2","value_numeric":null},{"paper_doi":"10.1016/j.euo.2026.07.014","tag_type":"modality","value":"Androgen Receptor Pathway Inhibitor","value_numeric":null},{"paper_doi":"10.1016/j.euo.2026.07.014","tag_type":"modality","value":"PARP Inhibitor","value_numeric":null},{"paper_doi":"10.1016/j.euo.2026.07.014","tag_type":"sample_size","value":"n=796","value_numeric":796},{"paper_doi":"10.1016/j.euo.2026.07.014","tag_type":"sex","value":"male","value_numeric":null},{"paper_doi":"10.1016/j.euo.2026.07.014","tag_type":"study_design","value":"Randomized Controlled Trial","value_numeric":null},{"paper_doi":"10.1016/j.euo.2026.07.014","tag_type":"warning","value":"Brand name 'Zytiga' is used for abiraterone; prednisone co-administration (standard with abiraterone) is not mentioned in the abstract.","value_numeric":null},{"paper_doi":"10.1016/j.euo.2026.07.014","tag_type":"warning","value":"The level of evidence is tagged as 2 (subgroup analysis of a phase 3 RCT); the primary trial is level 1, but these subgroup findings carry inherent limitations.","value_numeric":null},{"paper_doi":"10.1016/j.euo.2026.07.014","tag_type":"warning","value":"The total sample size (n=796) is inferred from the full PROpel trial; the abstract does not explicitly state the exact N. The HRRm subgroup size is not given as a precise integer.","value_numeric":null}],"summaries":{"what_studied":"This pre-specified subgroup analysis of PROpel (phase 3, double-blind RCT) examined efficacy of olaparib plus abiraterone vs. placebo plus abiraterone as first-line therapy in patients with mCRPC harboring single homologous recombination repair gene mutations (HRRm), determined via tumor tissue and ctDNA assays.","key_result":"Among the 28.4% of patients with an HRRm, BRCA2-mutated patients showed the strongest benefit: rPFS HR 0.20 (95% CI 0.08–0.44) and OS HR 0.20 (95% CI 0.07–0.48). ATM and CDK12 single-gene mutations showed numerically favorable but non-significant rPFS and OS HRs. Overall (biomarker-unselected), olaparib plus abiraterone improved rPFS (HR 0.66; p<0.0001) and median OS by 7.4 months (42.1 vs. ~34.7 mo).","limitations":"- Subgroups for most single HRRm genes other than BRCA2, ATM, and CDK12 had fewer than 5 events per arm, severely limiting interpretation.\n- HRRm status was determined by aggregating two assay platforms (tumor tissue + ctDNA), which may introduce heterogeneity in mutation detection.\n- ATM and CDK12 confidence intervals were wide and crossed 1.0, so benefit in these subgroups remains uncertain.","practice_takeaway":"Olaparib plus abiraterone provides a strong first-line benefit in mCRPC patients with BRCA2 mutations (rPFS and OS HR ~0.20) and should be prioritized in this group. For ATM and CDK12 single-gene mutations, benefit is numerically present but not statistically confirmed, so clinical judgment is needed."}},{"doi":"10.1136/jitc-2026-014803","pmid":"42493213","title":"Randomized phase II trial of nivolumab and ipilimumab with or without stereotactic body radiation therapy in patients with metastatic castration-resistant prostate cancer: the CheckPRO, CA209-8TY trial","journal_title":"Journal for ImmunoTherapy of Cancer","journal_issn":"2051-1426","published_at":"2026-07-23T00:00:00.000Z","url":"https://doi.org/10.1136/jitc-2026-014803","source_score":10,"is_retracted":false,"is_open_access":true,"raw_metadata":{"pubmed":true,"crossref":true,"unpaywall":true},"created_at":"2026-07-31T13:37:10.753Z","updated_at":"2026-07-31T13:37:10.753Z","tags":[{"paper_doi":"10.1136/jitc-2026-014803","tag_type":"age_group","value":"older_adult","value_numeric":null},{"paper_doi":"10.1136/jitc-2026-014803","tag_type":"brand","value":"Opdivo","value_numeric":null},{"paper_doi":"10.1136/jitc-2026-014803","tag_type":"brand","value":"Yervoy","value_numeric":null},{"paper_doi":"10.1136/jitc-2026-014803","tag_type":"category","value":"Immunology","value_numeric":null},{"paper_doi":"10.1136/jitc-2026-014803","tag_type":"condition","value":"Metastatic Castration-Resistant Prostate Cancer","value_numeric":null},{"paper_doi":"10.1136/jitc-2026-014803","tag_type":"generic","value":"ipilimumab","value_numeric":null},{"paper_doi":"10.1136/jitc-2026-014803","tag_type":"generic","value":"nivolumab","value_numeric":null},{"paper_doi":"10.1136/jitc-2026-014803","tag_type":"impact_flag","value":"confirms_prior","value_numeric":null},{"paper_doi":"10.1136/jitc-2026-014803","tag_type":"level_of_evidence","value":"2","value_numeric":null},{"paper_doi":"10.1136/jitc-2026-014803","tag_type":"modality","value":"Immune Checkpoint Inhibitor","value_numeric":null},{"paper_doi":"10.1136/jitc-2026-014803","tag_type":"modality","value":"Stereotactic Body Radiation Therapy","value_numeric":null},{"paper_doi":"10.1136/jitc-2026-014803","tag_type":"sample_size","value":"n=81","value_numeric":81},{"paper_doi":"10.1136/jitc-2026-014803","tag_type":"sex","value":"male","value_numeric":null},{"paper_doi":"10.1136/jitc-2026-014803","tag_type":"study_design","value":"Randomized Controlled Trial","value_numeric":null},{"paper_doi":"10.1136/jitc-2026-014803","tag_type":"warning","value":"Genomic/biomarker data (MSI, DDR status) are not yet reported, so the ~20% responder subset cannot be characterized from this publication alone.","value_numeric":null},{"paper_doi":"10.1136/jitc-2026-014803","tag_type":"warning","value":"Phase II trial design was not powered for a direct arm-vs-arm comparison; no p-values were used for between-arm differences per the statistical plan.","value_numeric":null},{"paper_doi":"10.1136/jitc-2026-014803","tag_type":"warning","value":"The evaluable population (n=81) fell short of the planned 40 per arm due to disproportionate dropouts in arm A before treatment, making the trial closer to observational for the SBRT comparison; results should be interpreted cautiously.","value_numeric":null}],"summaries":{"what_studied":"This randomized phase II trial (CheckPRO/CA209-8TY) evaluated nivolumab (3 mg/kg) plus ipilimumab (1 mg/kg) with SBRT (arm A, 24 Gy in 3 fractions) versus nivolumab plus ipilimumab alone (arm B) in 81 evaluable patients with mCRPC who had received ≥2 prior lines of therapy (nearly all had ≥3 lines including docetaxel and cabazitaxel). Dual primary endpoints were PSA50 response rate and ORR; median follow-up was 57.2 months.","key_result":"Adding SBRT did not improve outcomes: PSA50 response was 21.6% (arm A) vs 20.5% (arm B); ORR was 16.7% vs 22.2%; median OS was 10.2 vs 9.2 months. Grade 3–4 TRAEs occurred in 33.3% of all patients. Patients without a PFS event at 6 months had a markedly longer median OS (27.6 months vs 5.3 months for those who progressed by 6 months). Low baseline LDH, CRP ≤10 mg/L, and NLR <5 were each associated with longer OS.","limitations":"- Higher dropout rate in arm A (n=8) vs arm B (n=2) before treatment due to SBRT planning delays, creating imbalance and potential selection bias.\n- No genomic or translational biomarker data available yet (MSI/DDR status unknown), limiting interpretation of who may benefit.\n- Single-center design with small evaluable sample (n=81) and a long accrual period (Nov 2019–Jan 2024), reducing generalizability and novelty.","practice_takeaway":"SBRT does not enhance the response to nivolumab plus ipilimumab in heavily pretreated mCRPC; clinicians should not add SBRT to dual ICI outside a trial setting for this indication. About 20% of patients did respond to dual ICI alone, so biomarker-selected trials (e.g., MSI-high, DDR mutations) remain a priority for identifying who benefits."}},{"doi":"10.3390/cancers18142331","pmid":null,"title":"Theranostic Potential of 177Lu-TLX591 with Best Standard-of-Care and 68Ga-PSMA-11 PET for Patients with Metastatic Castration-Resistant Prostate Cancer: Results from the Phase 1 ProstACT SELECT Trial","journal_title":"Cancers","journal_issn":"2072-6694","published_at":"2026-07-20T00:00:00.000Z","url":"https://doi.org/10.3390/cancers18142331","source_score":44,"is_retracted":false,"is_open_access":true,"raw_metadata":{"pubmed":false,"crossref":true,"unpaywall":true},"created_at":"2026-07-25T13:58:01.047Z","updated_at":"2026-07-25T13:58:01.047Z","tags":[{"paper_doi":"10.3390/cancers18142331","tag_type":"age_group","value":"adult","value_numeric":null},{"paper_doi":"10.3390/cancers18142331","tag_type":"brand","value":"Illuccix","value_numeric":null},{"paper_doi":"10.3390/cancers18142331","tag_type":"brand","value":"TLX591","value_numeric":null},{"paper_doi":"10.3390/cancers18142331","tag_type":"category","value":"Oncology","value_numeric":null},{"paper_doi":"10.3390/cancers18142331","tag_type":"condition","value":"Metastatic Castration-Resistant Prostate Cancer","value_numeric":null},{"paper_doi":"10.3390/cancers18142331","tag_type":"generic","value":"177Lu-TLX591","value_numeric":null},{"paper_doi":"10.3390/cancers18142331","tag_type":"generic","value":"gallium Ga-68 gozetotide","value_numeric":null},{"paper_doi":"10.3390/cancers18142331","tag_type":"impact_flag","value":"limited_evidence","value_numeric":null},{"paper_doi":"10.3390/cancers18142331","tag_type":"level_of_evidence","value":"3","value_numeric":null},{"paper_doi":"10.3390/cancers18142331","tag_type":"modality","value":"Antibody-Drug Conjugate","value_numeric":null},{"paper_doi":"10.3390/cancers18142331","tag_type":"modality","value":"PET Imaging","value_numeric":null},{"paper_doi":"10.3390/cancers18142331","tag_type":"modality","value":"Radioligand Therapy","value_numeric":null},{"paper_doi":"10.3390/cancers18142331","tag_type":"sample_size","value":"n=30","value_numeric":30},{"paper_doi":"10.3390/cancers18142331","tag_type":"sex","value":"male","value_numeric":null},{"paper_doi":"10.3390/cancers18142331","tag_type":"study_design","value":"Phase 1 Non-Randomized Trial","value_numeric":null},{"paper_doi":"10.3390/cancers18142331","tag_type":"warning","value":"177Lu-TLX591 is an investigational agent not yet approved; brand name 'TLX591' is a development code, not a commercially approved brand name.","value_numeric":null},{"paper_doi":"10.3390/cancers18142331","tag_type":"warning","value":"Level of evidence assigned as 3 (non-randomized controlled trial/Phase 1); this is debatable given the single-arm design and small sample size — could be argued as level 4.","value_numeric":null},{"paper_doi":"10.3390/cancers18142331","tag_type":"warning","value":"No efficacy endpoints (e.g., PSA response, radiographic progression-free survival) are reported in the abstract; the study was primarily safety and dosimetry focused.","value_numeric":null},{"paper_doi":"10.3390/cancers18142331","tag_type":"warning","value":"The brand tag for gallium Ga-68 gozetotide (Illuccix) is assumed based on common clinical usage; the paper refers to 68Ga-PSMA-11 generically.","value_numeric":null}],"summaries":{"what_studied":"Phase 1 single-arm trial (ProstACT SELECT) evaluated 177Lu-TLX591 — a radio antibody–drug conjugate targeting PSMA — combined with best standard of care in 30 patients with mCRPC who progressed on androgen receptor pathway inhibitors; 68Ga-PSMA-11 PET was used for patient selection and compared with SPECT/CT imaging.","key_result":"Tumor targeting on 177Lu-TLX591 SPECT/CT was qualitatively consistent with 68Ga-PSMA-11 PET; no new safety signals emerged. Highest absorbed dose was to the liver (2.44 ± 0.56 Gy/GBq), while salivary gland (0.07 ± 0.03 Gy/GBq) and kidney (0.64 ± 0.17 Gy/GBq) exposures were low, and tumor activity was retained through 312 hours post-administration.","limitations":"Small sample size (n=30) in a single-arm design limits efficacy conclusions; no randomized comparator arm; qualitative rather than quantitative imaging concordance assessment between PET and SPECT/CT.","practice_takeaway":"68Ga-PSMA-11 PET appears to reliably select mCRPC patients for 177Lu-TLX591 therapy, and the agent's low salivary gland dosimetry may offer a tolerability advantage over other PSMA-targeted radioligand therapies. Larger randomized trials are needed before clinical adoption."}},{"doi":"10.1016/j.euf.2026.06.014","pmid":"42366147","title":"Radioligand Therapy for Prostate Cancer – A Clinical Consultation Guide","journal_title":"European Urology Focus","journal_issn":"2405-4569","published_at":"2026-06-28T00:00:00.000Z","url":"https://doi.org/10.1016/j.euf.2026.06.014","source_score":5,"is_retracted":false,"is_open_access":false,"raw_metadata":{"pubmed":true,"crossref":true,"unpaywall":true},"created_at":"2026-07-06T13:36:15.342Z","updated_at":"2026-07-06T13:36:15.342Z","tags":[{"paper_doi":"10.1016/j.euf.2026.06.014","tag_type":"age_group","value":"adult","value_numeric":null},{"paper_doi":"10.1016/j.euf.2026.06.014","tag_type":"brand","value":"Pluvicto","value_numeric":null},{"paper_doi":"10.1016/j.euf.2026.06.014","tag_type":"category","value":"Urology & Nephrology","value_numeric":null},{"paper_doi":"10.1016/j.euf.2026.06.014","tag_type":"condition","value":"Metastatic Castration-Resistant Prostate Cancer","value_numeric":null},{"paper_doi":"10.1016/j.euf.2026.06.014","tag_type":"condition","value":"Metastatic Hormone-Sensitive Prostate Cancer","value_numeric":null},{"paper_doi":"10.1016/j.euf.2026.06.014","tag_type":"condition","value":"Prostate Cancer","value_numeric":null},{"paper_doi":"10.1016/j.euf.2026.06.014","tag_type":"generic","value":"lutetium Lu 177 vipivotide tetraxetan","value_numeric":null},{"paper_doi":"10.1016/j.euf.2026.06.014","tag_type":"impact_flag","value":"practice_changing","value_numeric":null},{"paper_doi":"10.1016/j.euf.2026.06.014","tag_type":"level_of_evidence","value":"5","value_numeric":null},{"paper_doi":"10.1016/j.euf.2026.06.014","tag_type":"modality","value":"PSMA-Targeted Therapy","value_numeric":null},{"paper_doi":"10.1016/j.euf.2026.06.014","tag_type":"modality","value":"Radioligand Therapy","value_numeric":null},{"paper_doi":"10.1016/j.euf.2026.06.014","tag_type":"sex","value":"male","value_numeric":null},{"paper_doi":"10.1016/j.euf.2026.06.014","tag_type":"study_design","value":"Clinical Practice Guideline / Narrative Review","value_numeric":null},{"paper_doi":"10.1016/j.euf.2026.06.014","tag_type":"warning","value":"Publication date (2026-06-28) is very recent relative to today's date (2026-07-06); downstream guideline updates may not yet reflect this review.","value_numeric":null},{"paper_doi":"10.1016/j.euf.2026.06.014","tag_type":"warning","value":"The generic name used ('lutetium Lu 177 vipivotide tetraxetan') reflects the FDA-approved RxNorm form; the paper refers to the compound as '[177Lu]Lu-PSMA-617'.","value_numeric":null},{"paper_doi":"10.1016/j.euf.2026.06.014","tag_type":"warning","value":"This paper is a narrative clinical consultation guide, not a primary trial — no new efficacy or safety data are reported. Level of evidence reflects expert review, not a controlled study.","value_numeric":null}],"summaries":{"what_studied":"This clinical consultation guide summarizes evidence, patient selection strategies, toxicity monitoring, and future directions for PSMA-targeted radioligand therapy ([177Lu]Lu-PSMA-617) in prostate cancer, drawing on landmark trials (VISION, TheraP, PSMAfore) across mCRPC and emerging earlier-line settings.","key_result":"VISION, TheraP, and PSMAfore trials established that [177Lu]Lu-PSMA-617 improves overall survival, progression-free survival, and biochemical response rates in mCRPC; evidence is expanding to taxane-naïve disease, metastatic hormone-sensitive prostate cancer, and neoadjuvant settings.","limitations":"This is a narrative consultation guide, not a primary study — no new patient-level data are presented. Emerging imaging biomarkers for patient selection are described as investigational only. Evidence for earlier-line use (mHSPC, neoadjuvant) remains preliminary.","practice_takeaway":"Patient selection for PSMA-RLT should rely on PSMA PET imaging, disease burden assessment, and multidisciplinary team review. Clinicians should monitor for known toxicities and watch for evolving evidence supporting earlier use beyond heavily pretreated mCRPC."}},{"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":"10.1002/cncr.70371","pmid":"42186347","title":"Genetic ancestry–concordant ceramide metabolism and response to androgen receptor pathway inhibition in metastatic castration‐resistant prostate cancer","journal_title":"Cancer","journal_issn":"0008-543X","published_at":"2026-05-26T00:00:00.000Z","url":"https://doi.org/10.1002/cncr.70371","source_score":35,"is_retracted":false,"is_open_access":true,"raw_metadata":{"pubmed":true,"crossref":true,"unpaywall":true},"created_at":"2026-05-31T13:35:29.949Z","updated_at":"2026-05-31T13:35:29.949Z","tags":[{"paper_doi":"10.1002/cncr.70371","tag_type":"age_group","value":"adult","value_numeric":null},{"paper_doi":"10.1002/cncr.70371","tag_type":"brand","value":"Erleada","value_numeric":null},{"paper_doi":"10.1002/cncr.70371","tag_type":"brand","value":"Yonsa","value_numeric":null},{"paper_doi":"10.1002/cncr.70371","tag_type":"category","value":"Oncology","value_numeric":null},{"paper_doi":"10.1002/cncr.70371","tag_type":"condition","value":"Metastatic Castration-Resistant Prostate Cancer","value_numeric":null},{"paper_doi":"10.1002/cncr.70371","tag_type":"generic","value":"abiraterone","value_numeric":null},{"paper_doi":"10.1002/cncr.70371","tag_type":"generic","value":"apalutamide","value_numeric":null},{"paper_doi":"10.1002/cncr.70371","tag_type":"impact_flag","value":"limited_evidence","value_numeric":null},{"paper_doi":"10.1002/cncr.70371","tag_type":"level_of_evidence","value":"2","value_numeric":null},{"paper_doi":"10.1002/cncr.70371","tag_type":"modality","value":"Androgen Receptor Pathway Inhibitor","value_numeric":null},{"paper_doi":"10.1002/cncr.70371","tag_type":"modality","value":"Ceramide Metabolomics","value_numeric":null},{"paper_doi":"10.1002/cncr.70371","tag_type":"sample_size","value":"n=109","value_numeric":109},{"paper_doi":"10.1002/cncr.70371","tag_type":"sex","value":"male","value_numeric":null},{"paper_doi":"10.1002/cncr.70371","tag_type":"study_design","value":"Prospective Cohort Study","value_numeric":null},{"paper_doi":"10.1002/cncr.70371","tag_type":"warning","value":"Ancestry was self-reported or categorized as Black/White — the degree to which genetic ancestry was formally determined is not fully detailed in the abstract.","value_numeric":null},{"paper_doi":"10.1002/cncr.70371","tag_type":"warning","value":"Brand name tags (Erleada, Yonsa) are inferred from the generic drug names; the abstract does not explicitly name branded formulations.","value_numeric":null},{"paper_doi":"10.1002/cncr.70371","tag_type":"warning","value":"Sample sizes are small (n=44 in Abi Race, n=65 in PANTHER evaluable for metabolomics), so effect estimates should be interpreted cautiously.","value_numeric":null},{"paper_doi":"10.1002/cncr.70371","tag_type":"warning","value":"Study design is labeled 'Prospective Cohort' based on the described prospective trials with embedded metabolomic sub-studies; it is not a standalone RCT of ceramide modulation.","value_numeric":null}],"summaries":{"what_studied":"This study examined ceramide metabolite levels and their association with outcomes in Black and White patients with mCRPC treated with androgen receptor pathway inhibition (ARPI) — specifically abiraterone and apalutamide — across two prospective trials (Abi Race: 22 Black, 22 White; PANTHER: 28 Black, 37 White), measuring fasting serum sphingolipids pretreatment and on-treatment.","key_result":"Black patients had lower pretreatment total ceramide levels but higher pretreatment C24:C16 ceramide ratios than White patients. During ARPI, C24:C16 ratios fell in Black patients but rose in most White patients. Higher Cer(d18:1/20:0) was linked to shorter radiographic PFS and worse OS specifically in Black patients receiving apalutamide and abiraterone.","limitations":"Small sample sizes (total n=109 evaluable patients across both trials) limit statistical power and generalizability. Ancestry was categorized as Black or White, which may not fully capture the genetic diversity within these groups. Causal mechanisms linking ceramide shifts to treatment resistance are not established.","practice_takeaway":"Ceramide metabolite profiles — especially the C24:C16 ratio and Cer(d18:1/20:0) — differ by genetic ancestry and associate with ARPI outcomes in mCRPC. These biomarkers may eventually help identify Black patients at higher risk of shorter progression-free and overall survival, though prospective validation in larger cohorts is needed before clinical application."}},{"doi":"10.1097/01.ju.0001191680.76138.83.06","pmid":null,"title":"PD23-06 RADIOGRAPHIC PROGRESSION-FREE SURVIVAL AS A MEANINGFUL ENDPOINT IN METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (MCRPC): THE TALAPRO-2 RANDOMIZED CLINICAL TRIAL","journal_title":"Journal of Urology","journal_issn":"0022-5347","published_at":"2026-04-27T00:00:00.000Z","url":"https://doi.org/10.1097/01.ju.0001191680.76138.83.06","source_score":7,"is_retracted":false,"is_open_access":false,"raw_metadata":{"pubmed":false,"crossref":true,"unpaywall":true},"created_at":"2026-05-08T13:23:52.857Z","updated_at":"2026-05-08T13:23:52.857Z","tags":[{"paper_doi":"10.1097/01.ju.0001191680.76138.83.06","tag_type":"age_group","value":"adult","value_numeric":null},{"paper_doi":"10.1097/01.ju.0001191680.76138.83.06","tag_type":"brand","value":"Talzenna","value_numeric":null},{"paper_doi":"10.1097/01.ju.0001191680.76138.83.06","tag_type":"brand","value":"Xtandi","value_numeric":null},{"paper_doi":"10.1097/01.ju.0001191680.76138.83.06","tag_type":"category","value":"Urology & Nephrology","value_numeric":null},{"paper_doi":"10.1097/01.ju.0001191680.76138.83.06","tag_type":"condition","value":"Metastatic Castration-Resistant Prostate Cancer","value_numeric":null},{"paper_doi":"10.1097/01.ju.0001191680.76138.83.06","tag_type":"generic","value":"enzalutamide","value_numeric":null},{"paper_doi":"10.1097/01.ju.0001191680.76138.83.06","tag_type":"generic","value":"talazoparib","value_numeric":null},{"paper_doi":"10.1097/01.ju.0001191680.76138.83.06","tag_type":"impact_flag","value":"practice_changing","value_numeric":null},{"paper_doi":"10.1097/01.ju.0001191680.76138.83.06","tag_type":"level_of_evidence","value":"1","value_numeric":null},{"paper_doi":"10.1097/01.ju.0001191680.76138.83.06","tag_type":"modality","value":"Androgen Receptor Signaling Inhibitor","value_numeric":null},{"paper_doi":"10.1097/01.ju.0001191680.76138.83.06","tag_type":"modality","value":"PARP Inhibitor","value_numeric":null},{"paper_doi":"10.1097/01.ju.0001191680.76138.83.06","tag_type":"sex","value":"male","value_numeric":null},{"paper_doi":"10.1097/01.ju.0001191680.76138.83.06","tag_type":"study_design","value":"Randomized Controlled Trial","value_numeric":null},{"paper_doi":"10.1097/01.ju.0001191680.76138.83.06","tag_type":"warning","value":"Sample size tag omitted as total N was not reported in the available abstract text.","value_numeric":null},{"paper_doi":"10.1097/01.ju.0001191680.76138.83.06","tag_type":"warning","value":"The impact_flag 'practice_changing' is assigned based on the known significance of TALAPRO-2 in the mCRPC landscape, but confirmation from the full publication is advised.","value_numeric":null},{"paper_doi":"10.1097/01.ju.0001191680.76138.83.06","tag_type":"warning","value":"The paper is available only as a conference abstract (PD23-06 from a AUA meeting proceeding); full text data including specific hazard ratios, median rPFS values, and patient numbers were not provided, so quantitative details in the summary are limited.","value_numeric":null}],"summaries":{"what_studied":"The TALAPRO-2 randomized clinical trial evaluated radiographic progression-free survival (rPFS) as a meaningful clinical endpoint in patients with metastatic castration-resistant prostate cancer (mCRPC), assessing the treatment effect of talazoparib combined with enzalutamide.","key_result":"The trial supported rPFS as a meaningful endpoint in mCRPC, with the talazoparib plus enzalutamide combination demonstrating a statistically significant improvement in rPFS compared to placebo plus enzalutamide; specific hazard ratios and median survival numbers are not available in the provided abstract.","limitations":"Full numerical results and subgroup data are not available from the abstract alone, limiting precise quantitative interpretation. The clinical meaningfulness of rPFS as a surrogate for overall survival in mCRPC remains an ongoing debate in the field.","practice_takeaway":"Clinicians treating mCRPC can consider rPFS a meaningful endpoint when evaluating combination regimens like talazoparib plus enzalutamide. The TALAPRO-2 data support use of this endpoint to guide treatment decisions, particularly in patients with homologous recombination repair (HRR) gene alterations."}},{"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. 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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":9,"fetchConfig":{"kind":"tags","tags":[{"tag_type":"condition","value":"Metastatic Castration-Resistant Prostate Cancer"}]},"breadcrumbItems":[{"name":"Home","href":"/"},{"name":"Research Hub","href":"/hub"},{"name":"Conditions","href":"/hub/tag/condition"},{"name":"Metastatic Castration-Resistant Prostate Cancer"}],"hrefConfig":{"basePath":"/hub/papers","webViewQueryParams":{"hub_ctx":"tag","hub_tag_type":"condition","hub_tag_value":"Metastatic Castration-Resistant Prostate Cancer"}}}]]

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