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Evaluation of the Efficacy of Darolutamide Triplet Therapy in Patients With Metastatic Hormone-sensitive Prostate Cancer

NCT07031258 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2025-06-22

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Nanfang Hospital, Southern Medical University

    lead OTHER

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-30
Primary Completion
2026-12-31
Completion
2027-06-30
FDA Drug
Yes

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07031258 on ClinicalTrials.gov