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A prospective cohort study to evaluate the effect of AR-V7 expression on the prognosis of patients with high-risk metastatic hormone sensitive prostate cancer treated with androgen deprivation combined with abiraterone prednisone

A prospective cohort study to evaluate the effect of AR-V7 expression on the prognosis of patients with high-risk metastatic hormone sensitive prostate cancer treated with androgen deprivation combined with abiraterone prednisone

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200060707
Enrollment
Unknown
Registered
2022-06-08
Start date
2022-05-30
Completion date
Unknown
Last updated
2024-06-03

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

Conditions

prostatic cancer

Interventions

case series:NA

Sponsors

Zhongnan Hospital of Wuhan University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Prostate adenocarcinoma diagnosed by pathology; 2. Considered as high-risk metastatic prostate cancer by imaging examination including PMSA-PET and bone scan: Gleason score >= 8, there are three or more lesions in bone scan, or there are measurable visceral metastasis except lymph node metastasis; 3. Have not received any anti-tumor treatment including androgen deprivation before; 4. ECOG score <= 2; 5. Prostate cancer tissues can be obtained for AR-V7 immunohistochemical staining; 6. Patients planned to be treated with androgen deprivation combined with abiraterone prednisone.

Exclusion criteria

Exclusion criteria: 1. Patients whose life expectancy is less than 1 year; 2. Patients who have serious mental illness or are unable to cooperate with treatment or follow-up due to other reasons; 3. Patients who fail to treat according to the doctor's instructions; 4. Patients with other tumor diseases; 5. Prostate cancer with pathological types other than adenocarcinoma; 6. Patients with severe allergy to gonadotropin releasing hormone (GnRH) analogues; 7. Blood testosterone could not reach castration level (<= 50ng/mL) during treatment; 8. Patients receiving immunosuppressive therapy or with immune deficiency diseases; 9. Patients with severe liver function damage (Child Pugh grade C); 10. Patients with severe renal function injury who need long-term dialysis treatment; 11. Patients with severe myelosuppression 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;

Countries

China

Contacts

Public ContactHua Xu

Zhongnan Hospital of Wuhan University

xuhuawhu@163.com13971051016

Outcome results

None listed

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