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Study identifier: NCT05956639 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Comparing a 6-month vs Long-term Course of Rezvilutamide With ADT Plus Chemotherapy in mHSPC

Condition: Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)  ·  Sponsor: The First Affiliated Hospital with Nanjing Medical University

PhasePhase 3
Planned participants100
Who can joinMale, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Shangqian Wang, M.D.,PhD  ·  68303186  ·  wsq5501@126.com

Always discuss trial participation with your own doctor first.

Locations (1)

Urology dpt, First Affiliated Hospital of Nanjing Medical UniversityNanjing, Jiangsu, ChinaRecruiting

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Source record: clinicaltrials.gov/study/NCT05956639