{"preliminary_commentary":{"by_channel":{"youtube":2,"x_thread":1},"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":[["enzalutamide"]],"indication":"high-risk biochemically recurrent non-metastatic castration-sensitive prostate cancer","name":"EMBARK","nct_id":"NCT02319837","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=embark-nct02319837. The price is an estimate of verified statements from the commentary indexed so far, fixed at order. Final coverage is set when the report is built. 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_usd":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"Enzalutamide (160 mg) administered as four 40-mg capsules by mouth once daily in combination with leuprolide administered as as a single intramuscular or subcutaneous injection once every 12 weeks","label":"Enzalutamide plus leuprolide","type":"EXPERIMENTAL"},{"description":"Enzalutamide (160 mg) administered as four 40-mg capsules by mouth once daily","label":"Enzalutamide monotherapy","type":"EXPERIMENTAL"},{"description":"Enzalutamide placebo (placebo) capsules (identical in appearance to enzalutamide) administered as 4 capsules by mouth once daily in combination with leuprolide administered as a single intramuscular or subcutaneous injection once every 12 weeks.\n\nThe randomized blinded portion of the study has concluded following primary endpoint analyses. 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Enzalutamide in biochemically recurrent prostate cancer: key findings from subsequent analyses of EMBARK and their implications in clinical practice. Future Oncol. 2026 Jun;22(14):1593-1600. doi: 10.1080/14796694.2026.2676559. Epub 2026 Jun 23.","pmid":"42333826","type":"DERIVED"},{"citation":"Shore ND, Gleave M, De Giorgi U, Rannikko A, Pieczonka CM, Sridharan S, Brasso K, Woo HH, Gomez Caamano A, Saranchuk JW, Nordquist LT, Ferreira U, Tang Y, Rosbrook B, Haas GP, Rosales M, Zohren F, Tarazi J, Freedland SJ. Treatment of High-Risk Biochemically Recurrent Prostate Cancer With Enzalutamide in Combination With Leuprolide: Secondary End Points From the EMBARK Trial. J Urol. 2026 May;215(5):512-525. doi: 10.1097/JU.0000000000004890. Epub 2025 Dec 9.","pmid":"41364813","type":"DERIVED"},{"citation":"Shore ND, De Giorgi U, Tutrone RF, Bailen JL, Roos EPM, Kliment J, Marx G, Karsh LI, Ramirez-Backhaus M, Uchio EM, Supiot S, Tang Y, Rosbrook B, Haas GP, Rosales M, Zohren F, Tarazi J, Freedland SJ. Enzalutamide Monotherapy for the Treatment of Prostate Cancer With High-Risk Biochemical Recurrence: EMBARK Secondary End Points. J Urol. 2026 Apr;215(4):396-407. doi: 10.1097/JU.0000000000004879. Epub 2025 Dec 5.","pmid":"41349040","type":"DERIVED"},{"citation":"Shore ND, Luz MA, De Giorgi U, Gleave M, Gotto GT, Pieczonka CM, Haas GP, Kim CS, Ramirez-Backhaus M, Rannikko A, Kalac M, Sridharan S, Rosales M, Tang Y, Tutrone RF Jr, Venugopal B, Villers A, Woo HH, Wang F, Freedland SJ. Improved Survival with Enzalutamide in Biochemically Recurrent Prostate Cancer. N Engl J Med. 2026 Feb 5;394(6):563-575. doi: 10.1056/NEJMoa2510310. Epub 2025 Oct 19.","pmid":"41124201","type":"DERIVED"},{"citation":"De Giorgi U, Freedland SJ, Rannikko A, Ramirez-Backhaus M, Villers A, Tarazi J, Tang Y, Haas GP, Rosales M, Shore ND. Enzalutamide in patients with high-risk biochemically recurrent prostate cancer according to the European Association of Urology definition: a post hoc analysis of EMBARK. Prostate Cancer Prostatic Dis. 2026 Mar;29(1):198-201. doi: 10.1038/s41391-025-00959-8. Epub 2025 Mar 26.","pmid":"40140551","type":"DERIVED"},{"citation":"Morgan TM, Boorjian SA, Buyyounouski MK, Chapin BF, Chen DYT, Cheng HH, Chou R, Jacene HA, Kamran SC, Kim SK, Kirkby E, Luckenbaugh AN, Nathanson BJ, Nyame YA, Posadas EM, Tran PT, Chen RC. Salvage Therapy for Prostate Cancer: AUA/ASTRO/SUO Guideline Part III: Salvage Therapy After Radiotherapy or Focal Therapy, Pelvic Nodal Recurrence and Oligometastasis, and Future Directions. J Urol. 2024 Apr;211(4):526-532. doi: 10.1097/JU.0000000000003890. Epub 2024 Feb 29.","pmid":"38421252","type":"DERIVED"},{"citation":"Morgan TM, Boorjian SA, Buyyounouski MK, Chapin BF, Chen DYT, Cheng HH, Chou R, Jacene HA, Kamran SC, Kim SK, Kirkby E, Luckenbaugh AN, Nathanson BJ, Nyame YA, Posadas EM, Tran PT, Chen RC. Salvage Therapy for Prostate Cancer: AUA/ASTRO/SUO Guideline Part II: Treatment Delivery for Non-metastatic Biochemical Recurrence After Primary Radical Prostatectomy. J Urol. 2024 Apr;211(4):518-525. doi: 10.1097/JU.0000000000003891. Epub 2024 Feb 29.","pmid":"38421243","type":"DERIVED"},{"citation":"Freedland SJ, Gleave M, De Giorgi U, Rannikko A, Pieczonka CM, Tutrone RF, Venugopal B, Woo HH, Ramirez-Backhaus M, Supiot S, Lantz A, Ganguli A, Ivanova J, Kral P, Huang SP, Saad F, Shore ND. Enzalutamide and Quality of Life in Biochemically Recurrent Prostate Cancer. NEJM Evid. 2023 Dec;2(12):EVIDoa2300251. doi: 10.1056/EVIDoa2300251. Epub 2023 Oct 22.","pmid":"38320501","type":"DERIVED"},{"citation":"Freedland SJ, de Almeida Luz M, De Giorgi U, Gleave M, Gotto GT, Pieczonka CM, Haas GP, Kim CS, Ramirez-Backhaus M, Rannikko A, Tarazi J, Sridharan S, Sugg J, Tang Y, Tutrone RF Jr, Venugopal B, Villers A, Woo HH, Zohren F, Shore ND; EMBARK Study. Improved Outcomes with Enzalutamide in Biochemically Recurrent Prostate Cancer. N Engl J Med. 2023 Oct 19;389(16):1453-1465. doi: 10.1056/NEJMoa2303974.","pmid":"37851874","type":"DERIVED"},{"citation":"LBA02-09 EMBARK: A Phase 3 Randomized Study of Enzalutamide or Placebo Plus Leuprolide Acetate and Enzalutamide Monotherapy in High-risk Biochemically Recurrent Prostate Cancer. J Urol. 2023 Jul;210(1):224-226. doi: 10.1097/JU.0000000000003518. Epub 2023 May 2.","pmid":"37119051","type":"DERIVED"},{"citation":"Freedland SJ, De Giorgi U, Gleave M, Rosbrook B, Shen Q, Sugg J, Haas GP, Shore ND. A phase 3 randomised study of enzalutamide plus leuprolide and enzalutamide monotherapy in high-risk non-metastatic hormone-sensitive prostate cancer with rising PSA after local therapy: EMBARK study design. BMJ Open. 2021 Aug 12;11(8):e046588. doi: 10.1136/bmjopen-2020-046588.","pmid":"34385241","type":"DERIVED"}],"start_date":{"date":"2014-12-17","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Safety and Efficacy Study of Enzalutamide Plus Leuprolide in Patients With Nonmetastatic Prostate Cancer (EMBARK)","url":"https://clinicaltrials.gov/study/NCT02319837"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.1","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/embark-nct02319837"}