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

ConditionsMetastatic Hormone-sensitive Prostate CancerDarolutamide (DARO) in Combination With Androgen-deprivation Therapy (ADT) and Docetaxel (DOC)
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18+
SponsorNanfang Hospital, Southern Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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

Treatment groups

No treatment groups listed

Trial outcomes

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

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

Secondary outcomes

1

Radiological progression-free survival

Time from treatment initiation to radiological progression

Time frame
From the beginning of the patient's treatment to 6 months
2

PSA kinetics curve

The PSA decline curve from the start of ADT, darolutamide, and docetaxel treatment to the completion of docetaxel.

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nanfang Hospital, Southern Medical University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: