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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200058791
Enrollment
Unknown
Registered
2022-04-17
Start date
2022-04-22
Completion date
Unknown
Last updated
2024-01-22

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

Conditions

Prostate cancer

Interventions

Sponsors

Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
Male

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 form of anti-tumor treatment including androgen deprivation treatment before; 4. ECOG score <= 2; 5. Prostate cancer tissues can be obtained for AR-V7 immunohistochemical staining; 6. Patients who plan to receive androgen deprivation therapy combined with abiraterone prednisone.

Exclusion criteria

Exclusion criteria: 1. Patients with life expectancy less than 1 year; 2. Patients with serious mental illness or 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 neoplastic diseases; 5. Prostate cancer with other pathological types other than adenocarcinoma; 6. Patients with severe allergy to gonadotropin releasing hormone (GnRH) analogues; 7. Blood testosterone cannot reach the castration level (<= 50 ng/ml) during treatment; 8. Patients receiving immunosuppressive therapy or with immune deficiency diseases; 9. Patients with severe liver function impairment (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
Progress-free survival;

Secondary

MeasureTime frame
Overall survival;Proportion of Patients With PSA Complete Response;

Countries

China

Contacts

Public ContactHeng Li

Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology

lihengtjmu@163.com+86 18986292538

Outcome results

None listed

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