Efficacy and Safety of Apantamide Combined With Docetaxel and ADT vs. Apantamide Combined With ADT in Patients With High Tumor Burden mHSPC: a Multicenter and Prospective Cohort Study

EARLY_PHASE1RecruitingINTERVENTIONAL
Enrollment

220

Participants

Timeline

Start Date

March 1, 2023

Primary Completion Date

February 1, 2026

Study Completion Date

December 1, 2026

Conditions
Cohort Studies
Interventions
DRUG

apantamide+docetaxel+ADT

Apantamide, 240 mg (4 × 60 mg tablets), once a day, orally; ADT regimen was treated with gonadotropin releasing hormone analog (GnRHa), including GnRHa agonist or GnRHa antagonist. The type, frequency and dose of ADT to be used in each research center are determined by the investigator; The treatment of docetaxel was started within 6 weeks after the treatment of apantamide and ADT. The single dose of docetaxel was 75 mg/m2, intravenous drip for 1 hour, repeated every 3 weeks, and docetaxel lasted for 6 cycles.

DRUG

apantamide+ADT treatment

apantamide+ADT treatment

Trial Locations (1)

276600

RECRUITING

Qilu hospital, Jinan

All Listed Sponsors
lead

Qilu Hospital of Shandong University

OTHER