Evaluation of the Efficacy and Safety of Darolutamide + ADT Combined With Low-dose Docetaxel in mHSPC

Summary

This is a single-arm, prospective, multicenter, interventional study, aimed at exploring the efficacy and safety of darolutamide + ADT combined with low-dose docetaxel in treating patients with mHSPC planning to recruit approximately 109 patients. The purpose of this study is to investigate the proportion of patients who reach PSA undetectable (PSA\< 0.2ng/ml) at the primary analysis (24 weeks). According to the ARASENS study, the percentage of undetectable PSA in the experimental arm in the Chinese subset at 24 weeks is 46.2%. This study calculates that it is possible to maintain the therapeutic efficacy of PSA while reducing the dose of docetaxel.

Timeline

Start

2026-04

Primary completion

2027-12

Completion

2028-12

Publications

• Results Kamiya N, Suzuki H, Ueda T, Sato N, Nakatsu H, Mikami K, Sato N, Nomura K, Akakura K, Okano T, Ooki T, Naya Y, Ota S, Masai M, Ichikawa T. Clinical outcomes by relative docetaxel dose and dose intensity as chemotherapy for Japanese patients with castration-resistant prostate cancer: a retrospective multi-institutional collaborative study. Int J Clin Oncol. 2014 Feb;19(1):157-64. doi: 10.1007/s10147-012-0510-9. Epub 2013 Jan 9.
• Results Smith MR, Hussain M, Saad F, Fizazi K, Sternberg CN, Crawford ED, Kopyltsov E, Park CH, Alekseev B, Montesa-Pino A, Ye D, Parnis F, Cruz F, Tammela TLJ, Suzuki H, Utriainen T, Fu C, Uemura M, Mendez-Vidal MJ, Maughan BL, Joensuu H, Thiele S, Li R, Kuss I, Tombal B; ARASENS Trial Investigators. Darolutamide and Survival in Metastatic, Hormone-Sensitive Prostate Cancer. N Engl J Med. 2022 Mar 24;386(12):1132-1142. doi: 10.1056/NEJMoa2119115. Epub 2022 Feb 17.
• Results Jimenez N, Garcia de Herreros M, Reig O, Marin-Aguilera M, Aversa C, Ferrer-Mileo L, Garcia-Esteve S, Rodriguez-Carunchio L, Trias I, Font A, Rodriguez-Vida A, Climent MA, Cros S, Chirivella I, Domenech M, Figols M, Carles J, Suarez C, Herrero Rivera D, Gonzalez-Billalabeitia E, Civico C, Sala-Gonzalez N, Ruiz de Porras V, Ribal MJ, Prat A, Mellado B. Development and Independent Validation of a Prognostic Gene Expression Signature Based on RB1, PTEN, and TP53 in Metastatic Hormone-sensitive Prostate Cancer Patients. Eur Urol Oncol. 2024 Aug;7(4):954-964. doi: 10.1016/j.euo.2023.12.012. Epub 2024 Mar 1.

Drugs

Indications

No indication recorded.