Actively Recruiting
Phase II Study of Disitamab Vedotin and Abiraterone for Treating Metastatic Castration-Resistant Prostate Cancer in Men
Led by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Updated on 2025-07-30
20
Participants Needed
1
Research Sites
52 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of combining disitamab vedotin with abiraterone in men with metastatic castration-resistant prostate cancer mCRPC. This open-label, single-arm, phase 2 trial focuses on patients whose tumors express HER2. The study aims to provide important information about this treatment combination in this specific prostate cancer population. Participants receive disitamab vedotin intravenously at 2 mgkg every two weeks, along with daily oral doses of abiraterone 1000 mg and prednisone 5 mg twice daily. This treatment is given continuously during the study period to assess its impact on cancer progression and safety. The trial is conducted as a single experimental arm without a comparison group. During the study, participants will be monitored regularly through blood tests measuring prostate-specific antigen PSA levels up to 24 weeks, and imaging scans to track disease progression for up to 36 months. Safety evaluations and other assessments will be conducted throughout the trial. Participants are expected to be involved in treatment and follow-up visits according to the study schedule.
CONDITIONS
Brief Title
Efficacy and Safety of Disitamab Vedotin Plus Abiraterone for Metastatic Castration-Resistant Prostate Cancer：a Phase II Study
Research Team
H
Hongqian Guo Hong qian Guo
S
Shun Zhang Shun Zhang
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