prostate cancer
Conditions
Interventions
Control group:The control group received abiraterone 1000 mg orally once daily and prednisone 5 mg orally twice daily continuously until disease progression.
Intervention Group 1:After enrollment, patients received two cycles of bipolar androgen therapy (BAT) with intramuscular injection of testosterone propionate at a dose of 4 mg/kg body weight per 28?da
Intervention Group 2:After enrollment, patients received two cycles of bipolar androgen therapy (BAT) with intramuscular injection of testosterone propionate at a dose of 4 mg/kg body weight per 28?da
Sponsors
Beijing Hospital
Eligibility
Sex/Gender
Male
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 85 years; 2. Patients with metastatic castration-resistant prostate cancer (mCRPC) who have experienced treatment failure with prior novel androgen receptor inhibitors (ARIs) (excluding abiraterone) for metastatic hormone-sensitive prostate cancer (mHSPC), and who are permitted to have received chemotherapy in the hormone-sensitive setting, where CRPC is defined as serum testosterone 2 ng/mL), or radiographic progression (two or more new bone lesions on bone scan, or progression per RECIST criteria for solid tumors).; 3. No significant pain symptoms (NRS 6 months
Exclusion criteria
Exclusion criteria: 1. Prior receipt of bipolar androgen therapy (BAT). 2. Patients at high risk of pathological fracture or spinal cord compression due to bone metastases on imaging examination. 3. Concurrent autoimmune disease, uncontrolled infectious disease, severe cardiovascular or cerebrovascular disease, severe thrombosis-related disease, or interstitial pneumonia. 4. Allergy to testosterone, enzalutamide, or toripalimab. 5. Currently participating in another clinical trial. 6. History of psychiatric disorder, poor compliance, or deemed by the investigator to be unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease progression; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival (OS);PSA50 (>=50% decline in PSA from baseline);Objective response rate (ORR);Quality of Life (QoL) symptom relief rate;Comparison of pain scores after treatment completion;Occurrence of complications during treatment; | — |
Countries
China
Contacts
Public ContactMing Liu
Beijng Hospital
Outcome results
None listed