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Efficacy and safety of first-line chemotherapy with docetaxel plus platinum for metastatic castration-resistant prostate cancer with abnormal DNA damage repair genes

Efficacy and safety of first-line chemotherapy with docetaxel plus platinum for metastatic castration-resistant prostate cancer with abnormal DNA damage repair genes

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100053482
Enrollment
Unknown
Registered
2021-11-22
Start date
2021-11-15
Completion date
Unknown
Last updated
2023-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate cancer

Interventions

therapy group:Docetaxel plus platinum chemotherapy

Sponsors

Huadong Hospital Affiliated to Fudan University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Male, >=18 years old; 2. Pathologically confirmed prostate adenocarcinoma (prostate cancer, Pca); 3. The disease progresses after castration treatment, and the blood testosterone reaches the castration level; 4. The new generation of endocrine therapy drugs (abiraterone or enzalutamide, etc.) are resistant or not suitable for the new generation of endocrine therapy; 5. No chemotherapy (except estradiol phosphate mustard); 6. The DNA damage repair gene abnormality has been confirmed by the second-generation DNA sequencing technology; 7. Physical condition can tolerate chemotherapy; 8. Sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Received Pca chemotherapy in the past (except estradiol, except those who have completed adjuvant/neoadjuvant chemotherapy for more than 3 years, and those who have completed chemotherapy in the metastatic hormone-sensitive stage for more than 1 year); 2. There is a history of brain metastases, uncontrolled spinal cord compression or cancerous meningitis, or signs of new brain or leptomeningeal disease; 3. Any of the following conditions within 6 months before entering the study: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass grafting, NYHA class III or IV congestive heart failure, stroke or transient brain ischemic attack; 4. Previous use of PARP inhibitors; 5. History of docetaxel or platinum allergy.

Design outcomes

Primary

MeasureTime frame
prostate specific antigen;bone scan;

Secondary

MeasureTime frame
gene test;

Countries

China

Contacts

Public ContactSheng Lu

Huadong Hospital Affiliated to Fudan University

shlu213@126.com+86 18121220612

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026