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

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 w

Trial Details

NCT ID
NCT05956639
Phase
PHASE3
Sponsor
The First Affiliated Hospital with Nanjing Medical University
Status
RECRUITING
Cancer Type
Hormone-Sensitive Prostate Cancer
Interventions
  • 6-month course of antiandrogen drugs
  • Long-term course of antiandrogen drugs
Locations (sample)
  • Nanjing, Jiangsu, China|32.06167,118.77778

Key Eligibility Criteria

  • Inclusion criteria:
  • Age ≥ 18 years, male.
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
  • Histologically or cytologically confirmed prostate adenocarcinoma without evidence of neuroendocrine or small cell features.

For full eligibility, visit ClinicalTrials.gov.

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