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A prospective study of bipolar androgen followed by novel AR inhibitors combined with PD-1 inhibitors in the treatment of mCRPC

A prospective study of bipolar androgen followed by novel AR inhibitors combined with PD-1 inhibitors in the treatment of mCRPC

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600116595
Enrollment
Unknown
Registered
2026-01-12
Start date
2022-07-28
Completion date
Unknown
Last updated
2026-01-27

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

Conditions

prostate cancer

Interventions

treatment group:Intramuscular injection of testosterone propionate+Oral reverumide+Intravenous Carrilizumab

Sponsors

Beijing Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. metastatic prostate cancer with Gleason score >= 7; 2. diagnosis of denuded resistant prostate cancer (CRPC): 3. Age 18 to 85 years; 4. failure of chemotherapy or patients who cannot or do not wish to receive chemotherapy after failure of novel endocrine therapy; 5. No obvious pain symptoms (NRS = 90g/L, white blood cells >= 3.5 x 10^9/L, and neutrophils >= 1.5 x 10^9/L, platelets >= 100 x 10^9/L; (2) Creatinine 60 ml/min; (3) Alanine aminotransferase (ALT) <= 1.5 x upper limit of normal (UNL); aspartate aminotransferase (AST) <= 1.5 x upper limit of normal (UNL); alkaline phosphatase (ALP) <= 1.5 x upper limit of normal (4) Total bilirubin (TBIL) <= 1.5 x upper limit of normal (UNL). 8. Be able to cooperate with treatment and follow-up regularly; 9. Life expectancy of enrolled cancer patients should not be <4 months; 10. Sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Previously received BAT treatment; 2. Patients with high-risk skeletal lesions: bone scan nuclide accumulation, femoral or spinal metastases. Those with higher risk of pathological fracture or spinal cord compression; 3. Combined with the following diseases: autoimmune diseases, infectious diseases (HIV, HBV, HCV). Severe cardiovascular and cerebrovascular diseases (history of previous myocardial infarction and cerebral infarction), thrombosis-related diseases, intermittent qualitative pneumonia; 4. Patients with metastatic prostate cancer who require opioid pain relief; 5. More than 5 metastatic lesions in the lung or liver (non-specific nodules <=1 cm in the lung are not counted) 6. Patients with hypersensitivity to the active ingredients of ravelutamide or camrelizumab and any of the listed excipients need to be excluded; 7. Those who are participating in other clinical trials; 8. Those with a history of mental illness or those with poor compliance or who the researchers think are not suitable for participating in this study.

Design outcomes

Primary

MeasureTime frame
PSA remission rate after end of treatment;

Secondary

MeasureTime frame
Recurrence-free survival;objective response rate;overall survival;quality of life;Complications occurred during the treatment process;Comparison of pain scores after treatment;

Countries

China

Contacts

Public ContactShengjie Liu

Beijing Hospital

liushengjie0412@163.com+86 183 0123 0629

Outcome results

None listed

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