drugset / Trial / NCT01957436
A Phase III Study for Patients With Metastatic Hormone-naïve Prostate Cancer
Phase 3
Active not recruiting
1173 enrolled
UNICANCER
European Organisation for Research and Treatment of Cancer - EORTC · collabIpsen · collabJanssen-Cilag Ltd. · collabSanofi · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a multi-center phase III study to compare the clinical benefit of androgen deprivation therapy with or without docetaxel with or without local radiotherapy with or without abiraterone acetate and prednisone in patient with metastatic hormone-naïve prostate cancer.
Timeline
- Start
- 2013-11-13
- Primary completion
- 2021-08-18
- Completion
- 2032-12
Outcome
Met primary endpoint
paper In the overall population, patients assigned to receive abiraterone (n=583) had longer radiographic progression-free survival (hazard ratio [HR] 0·54, 99·9% CI 0·41-0·71; p<0·0001) PMID 35405085 ↗
paper and overall survival (0·82, 95·1% CI 0·69-0·98; p=0·030) than patients who did not receive abiraterone PMID 35405085 ↗
Publications
- Alyamani N, Clementel E, Sargos P, Blanchard P, Supiot S, Ronchin P, Pommier P, Duberge T, Silva M, Hammoud Y, Hasbini A, Khalifa J, Gnep K, Scrase C, Saez J, Vieillevigne L, Christiaens M, Zilli T, Ribault H, Bossi A, Fizazi K, Andratschke N. Radiotherapy quality assurance for the PEACE 1 trial: An individual case review analysis. Radiother Oncol. 2025 May;206:110780. doi: 10.1016/j.radonc.2025.110780. Epub 2025 Feb 7.
- Roubaud G, Kostine M, McDermott RS, Bernard-Tessier A, Maldonado X, Silva M, Flechon A, Berthold DR, Ronchin P, Tombal BF, Mourey L, Gravis G, Escande A, Abadie-Lacourtoisie S, Maurina T, Climent MA, Ribault H, Bossi A, Foulon S, Fizazi K. Assessment of bone mineral density in men with de novo metastatic castration-sensitive prostate cancer treated with or without abiraterone acetate plus prednisone in the PEACE-1 phase 3 trial. Eur J Cancer. 2025 Mar 11;218:115293. doi: 10.1016/j.ejca.2025.115293. Epub 2025 Feb 6.
- Fizazi K, Foulon S, Carles J, Roubaud G, McDermott R, Flechon A, Tombal B, Supiot S, Berthold D, Ronchin P, Kacso G, Gravis G, Calabro F, Berdah JF, Hasbini A, Silva M, Thiery-Vuillemin A, Latorzeff I, Mourey L, Laguerre B, Abadie-Lacourtoisie S, Martin E, El Kouri C, Escande A, Rosello A, Magne N, Schlurmann F, Priou F, Chand-Fouche ME, Freixa SV, Jamaluddin M, Rieger I, Bossi A; PEACE-1 investigators. Abiraterone plus prednisone added to androgen deprivation therapy and docetaxel in de novo metastatic castration-sensitive prostate cancer (PEACE-1): a multicentre, open-label, randomised, phase 3 study with a 2 x 2 factorial design. Lancet. 2022 Apr 30;399(10336):1695-1707. doi: 10.1016/S0140-6736(22)00367-1. Epub 2022 Apr 8.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Abiraterone acetate | Small molecule | 1000 mg | — |
| Subject | Docetaxel | Small molecule | 75 mg/m2 | Intravenous |
| Subject | Prednisone | Other / unclassified | 5 mg | Oral |