NCT07516704

Safety and Efficacy of Docetaxel, Darolutamide, and Homoharringtonine Combined With Androgen Deprivation Therapy in Neoadjuvant Treatment of High-Risk Prostate Cancer: A Multicenter Prospective, Single-Arm Clinical Study

• Status: Not Yet Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 94 (estimated)
• Sponsor: Zhongda Hospital · Academic / Other
• Sex: Male
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Previous study findings suggest that the efficacy limitations of the neoadjuvant treatment regimen combining docetaxel with androgen deprivation therapy are associated with protein synthesis. Homoharringtonine (HHT) is currently the only small-molecule translation elongation inhibitor approved by the U.S. Food and Drug Administration (FDA). Building on this foundation, we plan to conduct a prospective interventional study aimed at validating whether the intensified quadruple regimen, formed by adding darolutamide and homoharringtonine (HHT) to the standard regimen, can further significantly enhance the depth of pathological response and improve patient outcomes through multi-mechanism synergy.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Docetaxel+ Darolutamide + Homoharringtonine+ Androgen Deprivation Therapy	\*\*Docetaxel:\*\* 75 mg/m², intravenous infusion, once every 3 weeks (administered in weeks 1, 4, and 7), for a total of 3 cycles. To prevent allergic reactions and fluid retention, oral dexamethasone 8 mg is administered twice daily on the day before, the day of, and the day after docetaxel infusion. \*\*Darolutamide:\*\* 600 mg, orally, twice daily, starting from day 1 of treatment and continued until 1 week before surgery. To be taken with food. \*\*Homoharringtonine:\*\* 1 mg of homoharringtonine diluted in 250 mL of 5% glucose injection, administered intravenously once daily for two consecutive days, repeated every 3 weeks (administered in weeks 1, 4, and 7), for a total of 3 cycles. \*\*Androgen Deprivation Therapy:\*\* Luteinizing hormone-releasing hormone (LHRH) analogs such as goserelin. The specific dosage is goserelin 3.6 mg, administered as a subcutaneous injection into the anterior abdominal wall once every 28 day

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-12-01
• Completion: 2027-12-12
• First posted: 2026-04-08
• Last updated: 2026-04-08

Regulatory

• FDA-regulated drug study