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A prospective cohort study of androgen deprivation therapy combined with docetaxel chemotherapy in AR-V7 positive high-risk metastatic hormone sensitive prostate cancer

A prospective cohort study of androgen deprivation therapy combined with docetaxel chemotherapy in AR-V7 positive high-risk metastatic hormone sensitive prostate cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200061266
Enrollment
Unknown
Registered
2022-06-18
Start date
2022-06-30
Completion date
Unknown
Last updated
2023-03-26

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

Conditions

prostatic cancer

Interventions

None listed

Sponsors

Zhongnan Hospital of Wuhan University
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1. Pathologically diagnosed as prostate adenocarcinoma; 2. High-risk metastatic prostate cancer is considered by imaging examinations including PMSA-PET and bone scan: Gleason score >= 8, three or more lesions in bone scan, or measurable internal organs except lymph node metastasis transfer; 3. Have not received any form of anti-tumor therapy including androgen deprivation therapy before; 4. ECOG score <= 2; 5. Immunohistochemical staining of AR-V7 in prostate cancer tissue was positive; 6. Patients who can tolerate androgen deprivation therapy, docetaxel chemotherapy and abiraterone therapy.

Exclusion criteria

Exclusion criteria: 1. Patients with a life expectancy of less than 1 year; 2. Patients with severe mental illness or other reasons that prevent them from cooperating with treatment or follow-up; 3. Patients who fail to standardize treatment according to doctor's orders; 4. Patients with other tumor diseases; 5. Prostate cancer with pathological types other than adenocarcinoma; 6. Patients with severe allergies to gonadotropin-releasing hormone (GnRH) analogues; 7. Blood testosterone cannot reach castration level (<= 50 ng/ml) during treatment; 8. Patients receiving immunosuppressive therapy or with immunodeficiency diseases; 9. Patients with severe liver damage (Child-Pugh class C); 10. Patients with severe renal impairment requiring long-term dialysis treatment; 11. Patients with severe bone marrow suppression and severe neutropenia; 12. Participate in other clinical studies from 30 days before enrollment to the completion of this study.

Design outcomes

Primary

MeasureTime frame
Overall survival;Progression Free Survival;

Countries

China

Contacts

Public ContactHua Xu

Zhongnan Hospital of Wuhan University

xuhuawhu@163.com+86 13971051016

Outcome results

None listed

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