Trials / Not Yet Recruiting
Not Yet RecruitingNCT07031258
Evaluation of the Efficacy of Darolutamide Triplet Therapy in Patients With Metastatic Hormone-sensitive Prostate Cancer
Prospective Real-world Data Evaluation of Darolutamide (DARO) in Combination With Androgen-deprivation Therapy (ADT) and Docetaxel (DOC) in Patients With Metastatic Hormone-sensitive Prostate Cancer
- Status
- Not Yet Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 50 (estimated)
- Sponsor
- Nanfang Hospital, Southern Medical University · Academic / Other
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to investigate the clinical efficacy and safety of darolutamide combined with androgen deprivation therapy (ADT) and different dose-intensity docetaxel chemotherapy in the treatment of patients with metastatic hormone-sensitive prostate cancer.
Conditions
- Metastatic Hormone-sensitive Prostate Cancer
- Darolutamide (DARO) in Combination With Androgen-deprivation Therapy (ADT) and Docetaxel (DOC)
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Dose of docetaxel | According to the relative dose intensity of docetaxel (RDI; Defined as the ratio of the dose received to the full planned dose of 75mg/m2 per 6 cycles specified in the protocol) were divided into cohort 1 (patients receiving docetaxel dose intensity ≤80%) and cohort 2 (patients receiving docetaxel dose intensity ≤80%). A total of 50 patients who received docetaxel dose intensity \> 80% were planned to be enrolled, including 25 patients in the docetaxel dose intensity ≤80% group and 25 patients in the docetaxel dose intensity \> 80% group |
Timeline
- Start date
- 2025-06-01
- Primary completion
- 2026-12-01
- Completion
- 2027-06-01
- First posted
- 2025-06-22
- Last updated
- 2025-06-22
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07031258. Inclusion in this directory is not an endorsement.