NCT07503379

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

Evaluation of the Efficacy and Safety of Darolutamide + ADT Combined With Low-dose Docetaxel in mHSPC: a Multi-center, Prospective, Single-arm Study

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 109 (estimated)
• Sponsor: Yonghong Li · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• mHSPC

Interventions

Type	Name	Description
DRUG	Darolutamide + ADT Combined with Low-dose Docetaxel	1. Darolutamide This study used Darolutamide from Bayer Pharmaceuticals, with a specification of 300mg per tablet. The dose is 600 mg （2 tablets）, taken twice a day with meals. 2. Docetaxel The dose of docetaxel is 60mg/m2, administered intravenously on the first day of each cycle. This cycle should be repeated every 3 weeks for a maximum of 6 cycles. Docetaxel can be administered in combination with prednisone/prednisolone at the discretion of the researcher. To prevent hypersensitivity and fluid retention.

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-12-01
• Completion: 2028-12-01
• First posted: 2026-03-31
• Last updated: 2026-03-31

Locations

2 sites across 1 country: China