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A prospective, randomized controlled, multicenter clinical trial of indomethacin in the treatment of abiraterone-resistant castration-resistant prostate cancer

A prospective, randomized controlled, multicenter clinical trial of indomethacin in the treatment of abiraterone-resistant castration-resistant prostate cancer

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000038968
Enrollment
Unknown
Registered
2020-10-11
Start date
2020-10-30
Completion date
Unknown
Last updated
2021-01-11

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

Conditions

Prostate Cancer

Interventions

experiment group:indomethacin treatment
control group:Abiraterone treatment

Sponsors

The Second Hospital of Tianjin Medical University
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1. Patients with written informed consent; 2. Males aged 18 or above; 3. Patients with prostate malignant adenoma confirmed by histology or cytology; 4. Patients with mcrpc assessed by researchers according to NCCN, Eau or cau guidelines; 5. Blood cell count at the time of screening: hemoglobin >= 9.0 g / dl, absolute neutrophil count >= 1.5 x 10^9 / L, platelet count >= 100 x 10^9 / L (at the time of screening, subjects should not receive any growth factor treatment within 4 weeks before obtaining laboratory blood samples, or blood transfusion within 7 days before obtaining samples); 6. The screening values of serum alanine aminotransferase and / or aspartate aminotransferase were <= 1.5 x ULN, total bilirubin <= ULN, creatinine <=2.0 x ULN; 7. The patient did not receive any chemotherapy, abirateron, enzalutamide, radium-233, sipuleucel-t and other treatments to improve the survival of the patient.

Exclusion criteria

Exclusion criteria: 1. Patients with non metastatic hormone resistant prostate cancer; 2. Patients in the control group who could not complete the DP chemotherapy cycle due to failure of treatment and serious side effects; 3. Patients in the experimental group who could not complete the DC chemotherapy cycle, continuous treatment with abiraterone or continuous treatment with targeted therapy due to treatment failure and serious side effects; 4. Patients who have contraindications to CT and MRI contrast media and cannot complete follow-up review; 5. Patients who have received systemic therapy other than ADT; 6. Patients who are known to be allergic to any kind of research drug, similar drugs or excipients in research drug preparations; 7. Patients with any of the following conditions within 6 months before enrollment: stroke, myocardial infarction, severe / unstable angina pectoris, coronary artery / peripheral artery bypass grafting, congestive heart failure (New York Heart Association grade III or IV); 8. Patients with active viral hepatitis, known human immunodeficiency virus infection with detectable viral load, or chronic liver disease requiring treatment; 9. Patients with any other serious or unstable disease or medical, social or psychological condition that may endanger the safety of the subjects and / or affect their compliance with the test procedures, or may prevent the subjects from participating in the study or evaluating the results of the study; 10. Patients who cannot swallow oral medicine.

Design outcomes

Primary

MeasureTime frame
OS;PFS;PSA response rate;

Countries

China

Contacts

Public ContactZhiqun Shang

The Second Hospital of Tianjin Medical University

zhiqun_shang@tmu.edu.cn+86 18722292731

Outcome results

None listed

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