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

NCT07031258 | Not Yet Recruiting FDA Drug

• 1 other identifier: NFEC-2025-218
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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)

Outcome Measures

Primary Outcomes (1)

• 6-month prostate-specific antigen (PSA) undetectable rate

  The proportion of patients with PSA \<0.2 ng/mL after 6 months of treatment

  From the beginning of the patient's treatment to 6 months

Secondary Outcomes (2)

• Radiological progression-free survival

  From the beginning of the patient's treatment to 6 months

• PSA kinetics curve

  Every 3 weeks during the triplet therapy, and every month after treatment.

Interventions

Dose of docetaxel DRUG

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

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of patients diagnosed with metastatic hormone-sensitive prostate cancer who have chosen to receive darolutamide triplet therapy.

You may qualify if:

• Voluntarily signed informed consent form and able to understand and agree to comply with study requirements; Age ≥18； Male； Patients diagnosed with metastatic hormone-sensitive prostate cancer via CSCO guidelines, histopathology, etc.； Patients determined by treating physician to require darolutamide triplet therapy ECOG performance status score of 0-1 as evaluated by the Eastern Cooperative Oncology Group (ECOG) criteria； Life expectancy of over 1 year； Good compliance with regular serum PSA testing during treatment；

You may not qualify if:

• Presence of other malignancies within the past 2 years or currently; Severe cardiovascular/cerebrovascular disease within 6 months prior to study treatment initiation, including: severe/unstable angina, myocardial infarction, congestive heart failure \[NYHA Class III or worse\], stroke, or arrhythmia requiring medication; Allergy to any study drug or excipient; Inability to swallow, chronic diarrhea, intestinal obstruction, or other factors affecting drug intake/absorption; Underlying medical condition/alcohol or drug abuse/dependence that may interfere with drug administration, result in adverse events, or complicate outcome interpretation; Participation in another therapeutic clinical study; Deemed unsuitable for the study by the investigator.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Central Study Contacts

Wu Y Wang

CONTACT

China+15066541238; 1470329253@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2025
• First Posted: June 22, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: June 22, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share