30: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"] 2f:T432,{"@context":"https://schema.org","@type":"CollectionPage","name":"Post Hoc Analysis of Phase III Randomized Controlled Trials: study design Research & Clinical Takeaways","description":"Explore peer-reviewed papers on Post Hoc Analysis of Phase III Randomized Controlled Trials (study design). Clinician-written summaries and actionable practice insights. Updated daily.","url":"https://www.reachrx.ai/hub/tag/study_design/Post%20Hoc%20Analysis%20of%20Phase%20III%20Randomized%20Controlled%20Trials","breadcrumb":{"@type":"BreadcrumbList","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https://www.reachrx.ai"},{"@type":"ListItem","position":2,"name":"Research Hub","item":"https://www.reachrx.ai/hub"},{"@type":"ListItem","position":3,"name":"Study Designs","item":"https://www.reachrx.ai/hub/tag/study_design"},{"@type":"ListItem","position":4,"name":"Post Hoc Analysis of Phase III Randomized Controlled Trials","item":"https://www.reachrx.ai/hub/tag/study_design/Post%20Hoc%20Analysis%20of%20Phase%20III%20Randomized%20Controlled%20Trials"}]}}31:T764,In patients who received enzalutamide, we characterized the development of radiographic progression (rPD) without prostate-specific antigen (PSA) rise or progression in metastatic hormone-sensitive prostate cancer (mHSPC) and nonmetastatic castration-resistant prostate cancer (nmCRPC). We conducted a post hoc analysis in two phase III trials (N = 2,551; ARCHES [ClinicalTrials.gov identifier: NCT02677896]; PROSPER [ClinicalTrials.gov identifier: NCT02003924]) for co-occurrence of rPD ± Prostate Cancer Working Group 2/3-defined PSA progression, and rPD ± any PSA rise from baseline/nadir by treatment. Kaplan-Meier methods were used for overall survival (OS) outcomes. In ARCHES, 3.5% and 8.5% of 574 patients with mHSPC treated with enzalutamide plus androgen-deprivation therapy (ADT) had no PSA rise or PSA progression at rPD, respectively. Of 79 patients with rPD who received enzalutamide plus ADT, 25.3% had no PSA rise and 62.0% did not meet PSA progression criteria compared with 7.4% and 38.3% of 188 patients with rPD treated with ADT alone, respectively. In PROSPER, 4.4% and 10.3% of 933 patients with nmCRPC treated with enzalutamide plus ADT had no PSA rise or PSA progression, respectively, at rPD. However, of 187 patients with rPD who received enzalutamide plus ADT, 21.9% had no PSA rise and 51.3% did not meet PSA progression criteria compared with 3.6% and 18.8% of 224 patients treated with placebo/ADT, respectively. Liver metastases were >5-fold higher in enzalutamide-treated patients with rPD events versus control, although sample size was small. Compared with no rPD, enzalutamide-treated patients with rPD ± PSA rise or progression had worse OS. Given the frequent discordance and poor prognosis of imaging-based progression in the absence of PSA changes during enzalutamide treatment in mHSPC and nmCRPC, periodic surveillance using imaging is recommended.32:Tb70, PURPOSE In patients who received enzalutamide, we characterized the development of radiographic progression (rPD) without prostate-specific antigen (PSA) rise or progression in metastatic hormone-sensitive prostate cancer (mHSPC) and nonmetastatic castration-resistant prostate cancer (nmCRPC). Methods We conducted a post hoc analysis in two phase III trials (N = 2,551; ARCHES [ClinicalTrials.gov identifier: NCT02677896 ]; PROSPER [ClinicalTrials.gov identifier: NCT02003924 ]) for co-occurrence of rPD ± Prostate Cancer Working Group 2/3-defined PSA progression, and rPD ± any PSA rise from baseline/nadir by treatment. Kaplan-Meier methods were used for overall survival (OS) outcomes. RESULTS In ARCHES, 3.5% and 8.5% of 574 patients with mHSPC treated with enzalutamide plus androgen-deprivation therapy (ADT) had no PSA rise or PSA progression at rPD, respectively. Of 79 patients with rPD who received enzalutamide plus ADT, 25.3% had no PSA rise and 62.0% did not meet PSA progression criteria compared with 7.4% and 38.3% of 188 patients with rPD treated with ADT alone, respectively. In PROSPER, 4.4% and 10.3% of 933 patients with nmCRPC treated with enzalutamide plus ADT had no PSA rise or PSA progression, respectively, at rPD. However, of 187 patients with rPD who received enzalutamide plus ADT, 21.9% had no PSA rise and 51.3% did not meet PSA progression criteria compared with 3.6% and 18.8% of 224 patients treated with placebo/ADT, respectively. Liver metastases were >5-fold higher in enzalutamide-treated patients with rPD events versus control, although sample size was small. Compared with no rPD, enzalutamide-treated patients with rPD ± PSA rise or progression had worse OS. CONCLUSION Given the frequent discordance and poor prognosis of imaging-based progression in the absence of PSA changes during enzalutamide treatment in mHSPC and nmCRPC, periodic surveillance using imaging is recommended. 25:[[["$","script","0",{"type":"application/ld+json","dangerouslySetInnerHTML":{"__html":"$2f"}}]],["$","$L30",null,{"title":"Post Hoc Analysis of Phase III Randomized Controlled Trials: Research & Clinical Takeaways","description":"Browse Post Hoc Analysis of Phase III Randomized Controlled Trials research papers with clear, practical takeaways for your clinical practice.","papers":[{"doi":"10.1200/jco-24-02829","pmid":"41894648","title":"Radiographic Progression With and Without Prostate-Specific Antigen Rise in Patients With Advanced Prostate Cancer Treated With Enzalutamide","journal_title":"Journal of Clinical Oncology","journal_issn":"0732-183X","published_at":"2026-03-27T00:00:00.000Z","url":"https://doi.org/10.1200/jco-24-02829","source_score":41,"is_retracted":false,"is_open_access":true,"raw_metadata":{"ooir":{"day":"2026-05-08","doi":"10.1200/jco-24-02829","days":"7","issn":"0732-183X","rank":"4","field":"Clinical Medicine","score":"41","category":"Oncology","categories":["Oncology"],"_categories":["Oncology"]},"pubmed":{"doi":"10.1200/JCO-24-02829","title":"Radiographic Progression With and Without Prostate-Specific Antigen Rise in Patients With Advanced Prostate Cancer Treated With Enzalutamide.","journal":"Journal of clinical oncology : official journal of the American Society of Clinical Oncology","methods":"","results":"In ARCHES, 3.5% and 8.5% of 574 patients with mHSPC treated with enzalutamide plus androgen-deprivation therapy (ADT) had no PSA rise or PSA progression at rPD, respectively. Of 79 patients with rPD who received enzalutamide plus ADT, 25.3% had no PSA rise and 62.0% did not meet PSA progression criteria compared with 7.4% and 38.3% of 188 patients with rPD treated with ADT alone, respectively. In PROSPER, 4.4% and 10.3% of 933 patients with nmCRPC treated with enzalutamide plus ADT had no PSA rise or PSA progression, respectively, at rPD. However, of 187 patients with rPD who received enzalutamide plus ADT, 21.9% had no PSA rise and 51.3% did not meet PSA progression criteria compared with 3.6% and 18.8% of 224 patients treated with placebo/ADT, respectively. Liver metastases were >5-fold higher in enzalutamide-treated patients with rPD events versus control, although sample size was small. Compared with no rPD, enzalutamide-treated patients with rPD ± PSA rise or progression had worse OS.","abstract":"$31","keywords":[],"pubmed_id":"41894648","conclusions":"Given the frequent discordance and poor prognosis of imaging-based progression in the absence of PSA changes during enzalutamide treatment in mHSPC and nmCRPC, periodic surveillance using imaging is recommended.","publication_date":"2026-03-27T00:00:00"},"crossref":{"DOI":"10.1200/jco-24-02829","URL":"https://doi.org/10.1200/jco-24-02829","ISSN":["0732-183X","1527-7755"],"link":[{"URL":"https://ascopubs.org/doi/pdfdirect/10.1200/JCO-24-02829","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"page":"1309-1322","type":"journal-article","issue":"14","score":1,"title":["Radiographic Progression With and Without Prostate-Specific Antigen Rise in Patients With Advanced Prostate Cancer Treated With Enzalutamide"],"author":[{"given":"Andrew J.","family":"Armstrong","sequence":"first","affiliation":[{"name":"Department of Medicine, Division of Medical Oncology, Duke Cancer Institute Center for Prostate and Urologic Cancer, Duke University, Durham, NC"}]},{"given":"Arun A.","family":"Azad","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, Peter MacCallum Cancer Centre, Melbourne, Australia"},{"name":"Sir Peter MacCallum Department of Oncology, University of Melbourne, Parkville, Australia"}]},{"given":"Taro","family":"Iguchi","sequence":"additional","affiliation":[{"name":"Department of Urology, Kanazawa Medical University, Ishikawa, Japan"}]},{"given":"Arnulf","family":"Stenzl","sequence":"additional","affiliation":[{"name":"Department of Urology, University of Tübingen, Tübingen, Germany"}]},{"given":"Nicolas","family":"Mottet","sequence":"additional","affiliation":[{"name":"Department of Urology, University Hospital, St Etienne, France"}]},{"given":"David","family":"Russell","sequence":"additional","affiliation":[{"name":"Pfizer Inc, New York, NY"}]},{"given":"Matt","family":"Rosales","sequence":"additional","affiliation":[{"name":"Astellas Pharma Global Development, Northbrook, IL"}]},{"given":"Gabriel P.","family":"Haas","sequence":"additional","affiliation":[{"name":"Global Product Development, Astellas Pharma Inc, Northbrook, IL"}]},{"given":"Fred","family":"Saad","sequence":"additional","affiliation":[{"name":"University of Montreal Hospital Center, Montreal, QC, Canada"}]},{"given":"Maha","family":"Hussain","sequence":"additional","affiliation":[{"name":"Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL"}]},{"given":"Cora N.","family":"Sternberg","sequence":"additional","affiliation":[{"name":"Englander Institute for Precision Medicine, Meyer Cancer Center, Weill Cornell Medicine, New York, NY"}]}],"issued":{"date-parts":[[2026,5,10]]},"member":"233","prefix":"10.1200","source":"Crossref","volume":"44","created":{"date-time":"2026-03-27T19:59:07Z","timestamp":1774641547000,"date-parts":[[2026,3,27]]},"indexed":{"date-time":"2026-05-13T04:29:29Z","timestamp":1778646569019,"date-parts":[[2026,5,13]]},"subject":[],"abstract":"$32","language":"en","relation":{},"resource":{"primary":{"URL":"https://ascopubs.org/doi/10.1200/JCO-24-02829"}},"subtitle":[],"assertion":[{"name":"received","group":{"name":"publication_history","label":"Publication History"},"label":"Received","order":0,"value":"2024-12-23"},{"name":"revised","group":{"name":"publication_history","label":"Publication 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of Clinical Oncology"],"published-print":{"date-parts":[[2026,5,10]]},"reference-count":34,"published-online":null,"references-count":34,"short-container-title":["J Clin Oncol"],"is-referenced-by-count":1},"unpaywall":{"doi":"10.1200/jco-24-02829","is_oa":true,"title":"Radiographic Progression With and Without Prostate-Specific Antigen Rise in Patients With Advanced Prostate Cancer Treated With Enzalutamide","updated":"2026-03-29T15:52:41+00:00","published_date":"2026-03-27","best_oa_location":{"url":"https://doi.org/10.1200/jco-24-02829","pmh_id":null,"url_for_pdf":null,"url_for_landing_page":"https://doi.org/10.1200/jco-24-02829"}}},"created_at":"2026-05-11T13:21:05.013Z","updated_at":"2026-05-14T15:13:26.918Z","tags":[{"paper_doi":"10.1200/jco-24-02829","tag_type":"age_group","value":"adult","value_numeric":null},{"paper_doi":"10.1200/jco-24-02829","tag_type":"brand","value":"Xtandi","value_numeric":null},{"paper_doi":"10.1200/jco-24-02829","tag_type":"category","value":"Oncology","value_numeric":null},{"paper_doi":"10.1200/jco-24-02829","tag_type":"condition","value":"Metastatic Hormone-Sensitive Prostate Cancer","value_numeric":null},{"paper_doi":"10.1200/jco-24-02829","tag_type":"condition","value":"Nonmetastatic Castration-Resistant Prostate Cancer","value_numeric":null},{"paper_doi":"10.1200/jco-24-02829","tag_type":"generic","value":"enzalutamide","value_numeric":null},{"paper_doi":"10.1200/jco-24-02829","tag_type":"impact_flag","value":"practice_changing","value_numeric":null},{"paper_doi":"10.1200/jco-24-02829","tag_type":"level_of_evidence","value":"2","value_numeric":null},{"paper_doi":"10.1200/jco-24-02829","tag_type":"modality","value":"Androgen Deprivation Therapy","value_numeric":null},{"paper_doi":"10.1200/jco-24-02829","tag_type":"modality","value":"Androgen Receptor Inhibitor","value_numeric":null},{"paper_doi":"10.1200/jco-24-02829","tag_type":"sample_size","value":"n=2551","value_numeric":2551},{"paper_doi":"10.1200/jco-24-02829","tag_type":"sex","value":"male","value_numeric":null},{"paper_doi":"10.1200/jco-24-02829","tag_type":"study_design","value":"Post Hoc Analysis of Phase III Randomized Controlled Trials","value_numeric":null},{"paper_doi":"10.1200/jco-24-02829","tag_type":"warning","value":"Liver metastasis subgroup numbers were explicitly noted as small — those specific estimates should be interpreted cautiously.","value_numeric":null},{"paper_doi":"10.1200/jco-24-02829","tag_type":"warning","value":"The level of evidence is assigned as 2 based on the RCT source data, but the post hoc design introduces analytical limitations.","value_numeric":null},{"paper_doi":"10.1200/jco-24-02829","tag_type":"warning","value":"This is a post hoc analysis; findings are hypothesis-generating and not powered for formal subgroup comparisons.","value_numeric":null}],"summaries":{"what_studied":"Post hoc analysis of two phase III trials (ARCHES, n=574 mHSPC; PROSPER, n=933 nmCRPC; total N=2,551) examining how often radiographic progression (rPD) occurs without PSA rise or PSA progression in patients treated with enzalutamide plus ADT versus ADT alone/placebo.","key_result":"Among enzalutamide-treated patients with rPD, 25.3% (mHSPC) and 21.9% (nmCRPC) had no PSA rise at rPD — roughly 3–6× higher rates than control arms (7.4% and 3.6%, respectively). Liver metastases were >5-fold more common in enzalutamide-treated patients with rPD versus controls. Patients with rPD had worse overall survival regardless of PSA changes.","limitations":"Post hoc analysis limits causal inference. Sample sizes for rPD subgroups (especially liver metastases) were small. PSA progression criteria varied (PCWG2/3), which may affect cross-study comparability.","practice_takeaway":"PSA alone is an unreliable marker of disease control in patients on enzalutamide — up to 1 in 4 with radiographic progression show no PSA rise. Clinicians should use periodic imaging surveillance rather than relying solely on PSA trends to detect progression in mHSPC and nmCRPC."}}],"initialOffset":1,"fetchConfig":{"kind":"tags","tags":[{"tag_type":"study_design","value":"Post Hoc Analysis of Phase III Randomized Controlled Trials"}]},"breadcrumbItems":[{"name":"Home","href":"/"},{"name":"Research Hub","href":"/hub"},{"name":"Study Designs","href":"/hub/tag/study_design"},{"name":"Post Hoc Analysis of Phase III Randomized Controlled Trials"}],"hrefConfig":{"basePath":"/hub/papers","webViewQueryParams":{"hub_ctx":"tag","hub_tag_type":"study_design","hub_tag_value":"Post Hoc Analysis of Phase III Randomized Controlled Trials"}}}]]

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