Primary Objective: To explore whether a 6-month course of Rezvilutamide in the triple therapy regimen is non-inferior to long-term Rezvilutamide treatment in improving radiographic progression-free survival (rPFS) in patients with high tumor burden metastatic hormone-sensitive prostate cancer (mHSPC). Secondary Objectives: To evaluate and compare the time to prostate-specific antigen (PSA) progression, time to next bone-related event, time to initiation of subsequent anti-prostate cancer treatment, and objective response rate (ORR) between the 6-month and long-term course of Rezvilutamide with androgen deprivation therapy (ADT) plus docetaxel in patients with high tumor burden mHSPC. To assess and compare the incidence of adverse events between the 6-month and long-term course of Rezvilutamide with ADT plus docetaxel in patients with high tumor burden mHSPC. Exploratory Objectives: To observe the circulating tumor cell status at 6 months, 12 months, 18 months, and 24 months in patients with high tumor burden mHSPC receiving the triple therapy regimen.
Primary Study Endpoints: Radiographic progression-free survival (rPFS) Secondary Study Endpoints: Time to prostate-specific antigen (PSA) progression Time to next bone-related event (including fractures, spinal cord compression, radiation therapy, or surgery targeting the bones) Time to initiation of subsequent anti-prostate cancer treatment Objective response rate (ORR) Quality of life assessment scores
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
6-month course of Rezvilutamide and ADT + chemotherapy
Long-term course of Rezvilutamide and ADT + chemotherapy
Urology dpt, First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
RECRUITINGrPFS
Radiographic progression-free survival
Time frame: 36 months
Time to prostate-specific antigen (PSA) progression
Time to PSA doubling on ADT + Rezvilutamide + Chemo
Time frame: 36 months
Time to next bone-related event
including fractures, spinal cord compression, radiation therapy, or surgery targeting the bones
Time frame: 36 months
Time to initiation of subsequent anti-prostate cancer treatment
Bone related treatment; Radiation therapy
Time frame: through study completion, an average of 3 year
Objective response rate (ORR)
PSA response, tumor burden shrink on radiographic reports
Time frame: 36 months
Quality of life assessment scores
Quality of life form with higher score indicating a better life experience under cancer condition
Time frame: 36 months
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