NCT05249712

Efficacy and Safety of Darolutamide Combined With ADT in High-risk/Very High-risk Localized Prostate Cancer

Medical Ethics Committee of Nanjing Drum Tower Hospital Affiliated to Medical School of Nanjing University

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Academic / Other
• Sex: Male
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This trial aims to evaluate the efficacy and safety of neoadjuvant therapy with Darolutamide combined with Androgen-Deprivation Therapy in High-risk/Very high-risk localized prostate cancer. This trial is A prospective, single-arm, multicenter clinical trial. Treatment cycle is 24 weeks,

Detailed description

High risk prostate cancer (PCa) had worse outcomes on radical treatment results, short-time oncological results, even cancer-specific survival, than those low or mediate risk PCa. Neoadjuvant treatment before radical prostatectomy had been proven to get some benefits on peri-operation results, especially on reduction of tumor volume and minimization of biochemical recurrence. This study will evaluate the efficacy and safety of androgen deprivation therapy (ADT) with Darolutamide in neoadjuvant therapy for surgically resectable high-risk or very high-risk PCa.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Darolutamide 300 mg	600 mg (300 mg × 2 tablets) twice daily with meals, equivalent to a total daily dose of 1200 mg.
OTHER	Androgen deprivation therapy	The ADT regimen used by each patient will be determined by the investigator, and the dose and frequency of administration will be consistent with the prescribing information.

Timeline

• Start date: 2022-01-01
• Primary completion: 2023-01-01
• Completion: 2025-12-01
• First posted: 2022-02-22
• Last updated: 2023-01-03

Locations

1 site across 1 country: China