Metastatic castration-resistant prostate cancer
Conditions
Interventions
Trial Group:SBRT (Stereotactic Body Radiation Therapy) combined with Atezolizumab and Rivenlumab
Sponsors
The first affiliated hospital of anhui medical university
Eligibility
Sex/Gender
Male
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Age 18-75 years; 2.Patients must have histologically or cytologically confirmed adenocarcinoma of the prostate that has been clinically determined to be metastatic prostate cancer based on routine imaging (bone scan or CT/MRI) assessment; 3.Patients have evaluable visceral metastases or soft tissue lesions (outside the pelvic cavity) and are able to undergo a single premedication biopsy; or have lesion biopsy tissue within 30 days before enrollment; 4.Patients are able to undergo FDG PET/CT to assess FDG uptake status of metastases; 5.Patients must >= 1 novel endocrine therapy drug that has failed (e.g., abiraterone acetate, rezvilutamide, enzalutamide, apalutamide or darotamide, etc.) and/or Patient with docetaxel chemotherapy resistance or intolerance to chemotherapy; 6.Patients who have been treated with rezvilutamide and need to have had a PSA response during rezvilutamide therapy (defined as the proportion of patients with a 50% or greater decrease in serum PSA levels from baseline at any time on treatment and reconfirmed by testing after 3 weeks); 7.Patients have PSA progression (defined as elevated PSA levels on at least 2 consecutive assessments, with an interval greater than or equal to 1 week between each assessment and a PSA value greater than or equal to 1 ng/mL at screening), or radiographic disease progression on soft tissues with or without PSA progression according to RECIST 1.1 criteria, or bone lesion progression according to PCWG3 criteria: bone scan reveals >= 2 new bone lesions; 8.Patient requires ongoing ongoing luteinizing hormone-releasing hormone-releasing hormone (LHRHa) therapy throughout the study treatment period, or has undergone orchiectomy surgery; and serum testosterone levels maintained castration levels (= 6 months; 11.Normal bone marrow function: absolute neutrophil count >=1.5×10^9/L; platelets >= 75×10^9/L; Hemoglobin >= 90g/L; White blood cell count >= 3.0×10^9/L; 12.Normal liver function: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) 1.5 times ULN and direct bilirubin =50%; QTc = 3.5 mmol/L for blood potassium; 16.Normal blood pressure: systolic blood pressure = 50 mL/min; 18.Patients who are considered by the investigator to have the ability to ejaculate and are sexually active must agree to take effective contraceptive measures and not donate sperm from the first dose to the last dose of this study within 3 months; 19.Subject is able to understand and willing to sign the informed consent form; 20.Able to comply with the study visit schedule and other protocol requirements;
Exclusion criteria
Exclusion criteria: 1.Planned receipt of any other anti-tumor therapy during the treatment period of this study; 2.The metastatic lesions are only bone metastases or there are brain metastases; 3.Previous treatment includes immune checkpoint inhibitors (including PD-1, PD-L1, CDLA-4 inhibitors, etc.), or antitumor drugs that target T cells and activate the immune system; 4.Have a known other malignancy that is progressing or requires active treatment during the past 3 years. Subjects with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ who have received potentially curative therapy may be enrolled in the study; 5.Active autoimmune disease or active infection (including tuberculosis) requiring systemic treatment (e.g., use of disease-modifying drugs, corticosteroids, or immunosuppressive medications) during the past 2 years. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for renal or pituitary insufficiency) does not count as systemic therapy; 6.Diagnosed immunodeficiency or on chronic systemic steroid therapy (daily use of more than 10 mg prednisone or equivalent) or any other form of immunosuppressive therapy within 14 days prior to the first dose of study intervention; 7.Has a history of (non-infectious) pneumonitis requiring steroid therapy or currently has non-infectious pneumonitis; 8.Received radiation therapy or radionuclide therapy (such as Radium-223) within 28 days prior to study administration; or treatment with abiraterone within 1 week, noracetylcyclodigestrel within 10 days, and antiandrogen therapy within 2 weeks prior to study dosing; 9.Allergy or intolerance to the active ingredient or any of the excipients of PD-L1 monoclonal antibody; 10.Have a clear history of neurological and psychiatric disorders such as dementia, epilepsy, or seizures; 11.According to the judgment of the investigator, there are serious concomitant diseases that endanger the safety of the subject, or affect the subject's completion of this study (such as severe diabetes, thyroid disease, and psychosis, etc.), or there are factors that affect the safety of the patient or affect the patient's ability to provide informed consent (including abnormal laboratory tests), or there are any psychological, family, sociological or geographical conditions that affect the study protocol and follow-up plan; 12.The investigator is not suitable to participate in this clinical trial for any reason;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease Control Rate (DCR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of Life;Objective Response Rate (ORR);Prostate-Specific Antigen (PSA) Response Rate;Imaging-based Progression-Free Survival (i-PFS);PSA Progression-Free Survival (PSA PFS);Overall Survival (OS); | — |
Countries
China
Contacts
Public ContactTai Sheng
The first affiliated hospital of anhui medical university
Outcome results
None listed