Skip to content

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
ChiCTR2200061643
Enrollment
Unknown
Registered
2022-06-30
Start date
2022-06-16
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

Group A:Testosterone propionate

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1. ECOG score = 18 years; 3. Pathological results suggest prostate adenocarcinoma; 4. Progression after persistent androgen deprivation therapy (surgical castration/drug castration); 5. Serum testosterone is castration level (< 50 ng/dL); 6. The patient must have been treated with doxetazel and abiraterone acetate in the past, and subsequent disease progression (determined according to PSA criteria or radiological examination); 7. Two consecutive measurements of elevated PSA with an interval of at least two weeks; 8. The patient understands and is willing to sign a written informed consent form.

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 50;PSA progression free survival;

Secondary

MeasureTime frame
clinical or radiological progerssion free survival;quality of life;adverse event;

Countries

China

Contacts

Public ContactYang Lu

West China Hospital of Sichuan University

wycleflue@163.com+86 18980606829

Outcome results

None listed

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