A Study of SHR3680 in Treating Patients With Hormone Sensitive Prostate Cancer

Summary

The aim of this study is to compare the safety and efficacy of SHR3680 with bicalutamide in the treatment of patients with hormone sensitive prostate cancer.

Timeline

Start

2018-05-30

Primary completion

2023-04-30

Completion

2025-04-30

Outcome

Met primary endpoint

paper Rezvilutamide significantly improved radiographic progression-free survival compared with bicalutamide PMID 36075260 ↗

paper hazard ratio [HR] 0·44 [95% CI 0·33-0·58]; p<0·0001). PMID 36075260 ↗

Publications

• Wu JL, Jiang SS, Luo H, Dong P, Wang ZJ, Xing NZ, Ma T, Wang ZP, Gu XQ, Zhou GC, Xue XY, Sun ZQ, Yang Y, Wang CX, Shan GY, Zhang AL, Ding DG, Wang LP, Duan XH, Wang TT, He T, Lin CY, Zhong XW, Lian JP, Wang WL, Ye DW, Dai B. Impact of hepatotoxicity and lipid metabolism-related toxicity on survival and quality of life in patients with high-volume metastatic hormone-sensitive prostate cancer treated with rezvilutamide in the CHART trial: a post hoc analysis. BMC Med. 2026 Jun 30. doi: 10.1186/s12916-026-04985-8. Online ahead of print.
• Wang H, Jiang S, Luo H, Zhou F, He D, Ma L, Guo H, Liang C, Chong T, Jiang J, Chen Z, Wang Y, Zou Q, Tian Y, Xiao J, Huang J, Chen J, Dong Q, Zhang X, Li H, Yang X, Lian J, Wang W, Ye D. Patient-reported outcomes of rezvilutamide versus bicalutamide in combination with androgen deprivation therapy in high-volume metastatic hormone-sensitive prostate cancer patients (CHART): a randomized, phase 3 study. Signal Transduct Target Ther. 2024 Dec 18;9(1):351. doi: 10.1038/s41392-024-02064-z.
• Bian X, Gu W, Zhang X, Xie L, Wang S, Shi B, Sun T, Wei S, Weng Z, Xia S, Han B, Xu Z, Xing J, Zhang D, Xu D, Du C, He C, Wang Q, Yang X, Lian J, Wang W, Ye D. Correlation of PSA and survival in metastatic hormone-sensitive prostate cancer treated with rezvilutamide plus ADT in the CHART trial. Med. 2025 Feb 14;6(2):100520. doi: 10.1016/j.medj.2024.09.009. Epub 2024 Oct 16.
• Gu W, Han W, Luo H, Zhou F, He D, Ma L, Guo H, Liang C, Chong T, Jiang J, Chen Z, Wang Y, Zou Q, Tian Y, Xiao J, Huang J, Zhu S, Dong Q, Zhang X, Li H, Yang X, Chen C, Li J, Jin C, Zhang X, Ye D; CHART Investigators. Rezvilutamide versus bicalutamide in combination with androgen-deprivation therapy in patients with high-volume, metastatic, hormone-sensitive prostate cancer (CHART): a randomised, open-label, phase 3 trial. Lancet Oncol. 2022 Oct;23(10):1249-1260. doi: 10.1016/S1470-2045(22)00507-1. Epub 2022 Sep 5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Bicalutamide	Other / unclassified	50 mg	—
Subject	Rezvilutamide	Unknown	80 mg	—

Indications