Study Comparing Apantamide with Docetaxel plus ADT versus Apantamide with ADT Alone for Patients with High Tumor Burden Metastatic Hormone-Sensitive Prostate Cancer

What this Trial Is About

Researchers are evaluating the safety and effectiveness of two treatment combinations in patients with high tumor burden metastatic hormone-sensitive prostate cancer mHSPC. This multicenter, prospective cohort study compares apantamide combined with docetaxel and androgen deprivation therapy ADT versus apantamide combined with ADT alone. The study includes 220 patients and aims to provide data on treatment outcomes and manage side effects under clinical supervision. Participants are divided into two groups one receives apantamide, docetaxel, and ADT, while the other receives apantamide and ADT. Apantamide is taken orally daily at 240 mg. ADT uses gonadotropin releasing hormone analogs as per each research centers protocols. Docetaxel is given intravenously every three weeks for six cycles, starting within six weeks after beginning apantamide and ADT. Dosages are adjusted based on adverse reactions, and preventive medications may be used to reduce side effects. Treatment continues until clinical benefit is no longer observed, intolerable side effects occur, or the patient withdraws consent. During the study, patients are monitored for progression of cancer using imaging and laboratory assessments. The main outcome measured is the three-year radiographic progression-free survival rate. Secondary outcomes include time to castration-resistant prostate cancer, PSA progression time, and survival without asymptomatic skeletal events. Patients undergo regular evaluations to track safety, treatment response, and overall health. The study is expected to complete by December 2026, with ongoing monitoring throughout the treatment period.

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