{"preliminary_commentary":{"by_channel":{"x_thread":3},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. This is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this."},"free_build":{"available":false},"commentary_summary":null,"drugs_tested":null,"indication":null,"name":"ARCHES","nct_id":"NCT02677896","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=arches-nct02677896. The price is an estimate of verified statements from the commentary indexed so far. Final coverage is set when the report is built. You never pay more than quoted: if the report is delivered at a smaller size, you pay that size's price, and anything paid above it is refunded. We build the report within 24 hours of confirming the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_rule":"Never more than quoted: the buyer pays the smaller of price_usd and the price the delivered edition is sold at.","price_usd":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":"ARCHES","arms":[{"description":"Participants received 160 mg enzalutamide orally once daily during double-blind treatment period until radiographic progression was documented or until the participants started an investigational agent or new therapy for treatment of prostate cancer or until any other discontinuation criterion was met. Eligible participants who received enzalutamide during double-blind treatment period and provided informed consent to take part in open-label period continued to receive 160 mg enzalutamide orally once daily in open-label period until disease progression, unacceptable toxicity or any other discontinuation criteria were met. ADT (either bilateral orchiectomy or Luteinizing hormone-releasing hormone (LHRH) agonist/antagonist) was maintained during study treatment as per standard of care and provided by the site's pharmacy stock.","label":"Enzalutamide + Androgen Deprivation Therapy (ADT)","type":"EXPERIMENTAL"},{"description":"Participants received matching placebo orally once daily during double-blind treatment period until radiographic progression was documented or until the participants started an investigational agent or new therapy for treatment of prostate cancer or until any other discontinuation criterion was met. ADT (either bilateral orchiectomy or LHRH agonist/antagonist) was maintained during study treatment as per standard of care and provided by the site's pharmacy stock.","label":"Placebo + Androgen Deprivation Therapy (ADT)","type":"PLACEBO_COMPARATOR"},{"description":"Eligible participants who received enzalutamide matching placebo during double-blind treatment period and provided informed consent to take part in open-label period switched to receive 160 mg enzalutamide orally once daily in open-label period until disease progression, unacceptable toxicity or any other discontinuation criteria were met. ADT (either bilateral orchiectomy or LHRH agonist/antagonist) was maintained during study treatment as per standard of care and provided by the site's pharmacy stock.","label":"Placebo followed by Enzalutamide","type":"EXPERIMENTAL"}],"collaborators":["Medivation LLC, a wholly owned subsidiary of Pfizer Inc."],"completion_date":{"date":"2024-07-31","type":"ACTUAL"},"conditions":["Metastatic Hormone Sensitive Prostate Cancer"],"enrollment":{"count":1150,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Enzalutamide","otherNames":["Xtandi"],"type":"DRUG"},{"name":"Placebo","otherNames":[],"type":"DRUG"}],"last_update":"2025-10-24","lead_sponsor":"Astellas Pharma Global Development, Inc.","official_title":"A Multinational, Phase 3, Randomized, Double-blind, Placebo-controlled Efficacy and Safety Study of Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus ADT in Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC)","overall_status":"COMPLETED","phases":["PHASE3"],"primary_completion_date":{"date":"2018-10-14","type":"ACTUAL"},"primary_outcomes":[{"measure":"Radiographic Progression-Free Survival (rPFS) Based on Independent Central Review (ICR) of Bone Scan According to Prostate Cancer Clinical Trials Working Group 2 (PCWG2) Criteria","timeFrame":"From the date of randomization to the first objective evidence of rPD at any time or death (maximum duration was 26.6 months)"},{"measure":"rPFS Based on ICR of Bone Scan According to Protocol Assessment Criteria","timeFrame":"From the date of randomization to the first objective evidence of rPD at any time or death (maximum duration was 26.6 months)"}],"references":[{"citation":"Armstrong AJ, Szmulewitz RZ, Petrylak DP, Holzbeierlein J, Villers A, Azad A, Alcaraz A, Alekseev B, Iguchi T, Shore ND, Rosbrook B, Sugg J, Baron B, Chen L, Stenzl A. ARCHES: A Randomized, Phase III Study of Androgen Deprivation Therapy With Enzalutamide or Placebo in Men With Metastatic Hormone-Sensitive Prostate Cancer. J Clin Oncol. 2019 Nov 10;37(32):2974-2986. doi: 10.1200/JCO.19.00799. Epub 2019 Jul 22.","pmid":"31329516","type":"RESULT"},{"citation":"Armstrong AJ, Azad AA, Iguchi T, Stenzl A, Mottet N, Russell D, Rosales M, Haas GP, Saad F, Hussain M, Sternberg CN. Radiographic Progression With and Without Prostate-Specific Antigen Rise in Patients With Advanced Prostate Cancer Treated With Enzalutamide. J Clin Oncol. 2026 May 10;44(14):1309-1322. doi: 10.1200/JCO-24-02829. Epub 2026 Mar 27.","pmid":"41894648","type":"DERIVED"},{"citation":"Azad AA, Petrylak DP, Iguchi T, Shore ND, Villers A, Gomez-Veiga F, Alcaraz A, Alekseev B, Szmulewitz RZ, Holzbeierlein J, Rosbrook B, Ma J, Zohren F, El-Chaar NN, Haas GP, Stenzl A, Armstrong AJ. Enzalutamide and Prostate-Specific Antigen Levels in Metastatic Prostate Cancer: A Secondary Analysis of the ARCHES Randomized Clinical Trial. JAMA Netw Open. 2025 May 1;8(5):e258751. doi: 10.1001/jamanetworkopen.2025.8751.","pmid":"40332939","type":"DERIVED"},{"citation":"Armstrong AJ, Azad AA, Conduit C, Haas GP, Bland C, Davis ID. Enzalutamide in metastatic hormone-sensitive prostate cancer: A plain language summary of the ARCHES and ENZAMET follow-up studies. Future Oncol. 2025 Jan;21(1):15-24. doi: 10.1080/14796694.2024.2408101. Epub 2024 Oct 15.","pmid":"39404227","type":"DERIVED"},{"citation":"Armstrong AJ, Iguchi T, Azad AA, Villers A, Alekseev B, Petrylak DP, Szmulewitz RZ, Alcaraz A, Shore ND, Holzbeierlein J, Gomez-Veiga F, Rosbrook B, Zohren F, Haas GP, Gourgiotti G, El-Chaar N, Stenzl A. The Efficacy of Enzalutamide plus Androgen Deprivation Therapy in Oligometastatic Hormone-sensitive Prostate Cancer: A Post Hoc Analysis of ARCHES. Eur Urol. 2023 Aug;84(2):229-241. doi: 10.1016/j.eururo.2023.04.002. Epub 2023 May 12.","pmid":"37179240","type":"DERIVED"},{"citation":"Cella D, Ganguli A, Turnbull J, Rohay J, Morlock R. US Population Reference Values for Health-Related Quality of Life Questionnaires Based on Demographics of Patients with Prostate Cancer. Adv Ther. 2022 Aug;39(8):3696-3710. doi: 10.1007/s12325-022-02204-3. Epub 2022 Jun 22.","pmid":"35731340","type":"DERIVED"},{"citation":"Armstrong AJ, Azad AA, Iguchi T, Szmulewitz RZ, Petrylak DP, Holzbeierlein J, Villers A, Alcaraz A, Alekseev B, Shore ND, Gomez-Veiga F, Rosbrook B, Zohren F, Yamada S, Haas GP, Stenzl A. Improved Survival With Enzalutamide in Patients With Metastatic Hormone-Sensitive Prostate Cancer. J Clin Oncol. 2022 May 20;40(15):1616-1622. doi: 10.1200/JCO.22.00193. Epub 2022 Apr 14.","pmid":"35420921","type":"DERIVED"},{"citation":"Stenzl A, Dunshee C, De Giorgi U, Alekseev B, Iguchi T, Szmulewitz RZ, Flaig TW, Tombal B, Morlock R, Ivanescu C, Ramaswamy K, Saad F, Armstrong AJ. Effect of Enzalutamide plus Androgen Deprivation Therapy on Health-related Quality of Life in Patients with Metastatic Hormone-sensitive Prostate Cancer: An Analysis of the ARCHES Randomised, Placebo-controlled, Phase 3 Study. Eur Urol. 2020 Oct;78(4):603-614. doi: 10.1016/j.eururo.2020.03.019. Epub 2020 Apr 23.","pmid":"32336645","type":"DERIVED"}],"start_date":{"date":"2016-03-09","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Study of Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus ADT in Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC)","url":"https://clinicaltrials.gov/study/NCT02677896"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.2","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/arches-nct02677896"}