NCT06177015

Intermittent Darolutamide Treatment in the Triple Therapy of mHSPC

Randomized Controlled Study on the Efficacy and Safety of Intermittent Darolutamide Treatment in the Triple Therapy of Metastatic Hormone Sensitive Prostate Cancer

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: Male
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy and safety of intermittent use of darolutamide compared to long-term use in combination with ADT and docetaxel in the treatment of mHSPC patients.

Detailed description

Patients will firstly receive 6 months of darolutamide in combination with docetaxel and ADT treatment. 1\. When the patient reaches: 1. PSA ≤ 0.2ng/ml 2. Or PSA \> 0.2ng/ml but with more that 90% decrease comparing baseline 3. Without newly discovered metastatic lesions. They will be randomly assigned in a 1:1 ratio to either continuous treatment group or intermittent treatment group (1) Continuous treatment group: Darolutamide: 600mg, bid+ADT: Leuprorelin (3.6mg qm or 10.8mg q3m) or goserelin 80mg qm until mCRPC; (2) Intermittent treatment group: Only ADT as background treatment without Darolutamide. PSA check every three months, when the patient's PSA \> 1ng/ml (or PSA \> 1ng/ml and PSA has risen by more than 20% comparing baseline), restart the darolutamide, until mCRPC. 2\. When the patient: 1. PSA \> 0.2ng/ml and has not decreased by 90% compared to baseline 2. Or has new metastatic lesions, they will exit the study. Imaging assessment will be conducted every 3 months

Conditions

• Metastatic Prostate Cancer
• Intermitent Anti-androgen Therapy

Interventions

Type	Name	Description
DRUG	Darolutamide continuous	standard of care
DRUG	Darolutamide intermittent	experimental group

Timeline

• Start date: 2023-12-11
• Primary completion: 2025-12-31
• Completion: 2027-12-31
• First posted: 2023-12-20
• Last updated: 2023-12-26

Locations

1 site across 1 country: China