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Efficacy and safety of bipolar androgen therapy in mCRPC after progression on abiraterone or docetaxel: A prospective single-arm clinical study based on Chinese populations

Efficacy and safety of bipolar androgen therapy in mCRPC after progression on abiraterone or docetaxel: A prospective single-arm clinical study based on Chinese populations

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200061437
Enrollment
Unknown
Registered
2022-06-24
Start date
2022-06-10
Completion date
Unknown
Last updated
2023-04-03

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

Conditions

Prostate Cancer

Interventions

Experimental group:bipolar androgen therapy

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. ECOG score =18 years; 3. Pathological findings suggested prostate adenocarcinoma; 4. Progress after treatment of persistent androgen deprivation (surgical castration/drug castration); 5. Serum testosterone was castrated (<50 ng/dl); 6. Patients must have been treated with docetaxel and abiraterone acetate in the past and have subsequently developed disease progression (as determined by PSA criteria or radiological examination); 7. PSA elevation was measured twice in succession with an interval of at least two weeks; 8. The patient understands and is willing to sign the written informed consent.

Exclusion criteria

Exclusion criteria: 1. Use opioid painkillers to control the pain caused by metastatic prostate cancer; 2. There are more than 5 metastatic foci in the lungs or liver; 3. Secondary urinary tract obstruction caused by prostatic hyperplasia or prostate cancer requires urinary catheterization; 4. Researchers believe that testosterone therapy increases the risk of disease occurrence in certain areas or degrees (e.g., femoral metastasis is related to fracture risk, spinal metastasis is related to spinal cord compression, and lymph node disease is related to ureteral obstruction); 5. Previously severe/unstable medical, psychiatric or other conditions (including laboratory abnormalities) that may interfere with the patient's safety or provide informed consent to participate in the study; 6. Any psychological, family, sociological or geographical conditions that may affect their compliance with the research plan and follow-up work; 7. There is a previous history of thromboembolism in the past two years, and there is no systemic anticoagulation therapy at present.

Design outcomes

Primary

MeasureTime frame
PSA drops by half;PSA progression free survival;

Secondary

MeasureTime frame
clinical/radiogarphical progression free survival;quality of life;

Countries

China

Contacts

Public ContactYang Lu

West China Hospital, Sichuan University

wycleflue@163.com+86 18980606829

Outcome results

None listed

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