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The aim of this study is to evaluate the efficacy of 2 cycles of combinatory adebrelimab and stereotactic radiotherapy, followed by monotherapy adebrelimab in patients with metastatic castration-resistant prostate cancer. Dr. Yao Zhu from Fudan University Shanghai Cancer Center is the co-leading PI of this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group | Experimental | Stereotactic body radiotherapy of 8 Gray (Gy) x 3 on targeted metastasis determined by MDT + Adebrelimab 20mg/kg IV every 3 weeks (Q3W) for 2 cycles, then Adebrelimab 20mg/kg IV alone Q3W until progression |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stereotactic body radiotherapy | Radiation | 8 Gray x 3 for 2 cycles |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Control Rate | DCR (Disease Control Rate) is defined as the proportion of patients with a confirmed complete response (CR) or partial response (PR) of any duration, or stable disease (SD)/non-CR/nonprogressive disease (non-PD) for ≥6 months according to modified Response Evaluation Criteria in Solid Tumours (RECIST1.1) per Prostate Cancer Clinical Trials Working Group (PCWG3) criteria | From baseline until progression (up to 24 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate | ORR (objective response rate) is defined as the proportion of patients with a confirmed complete response (CR) or partial response (PR) of any duration according to modified Response Evaluation Criteria in Solid Tumours (RECIST1.1) per Prostate Cancer Clinical Trials Working Group (PCWG3) criteria | From baseline until progression (up to 24 months) |
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Inclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yao Zhu | Contact | 13816751347 | zhuyao@fudan.edu.cn | |
| Yu Wei | Contact | 17621008152 | yuwei21@m.fudan.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujian Cancer Hospital | Recruiting | Fuzhou | Fujian | 350014 | China |
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| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
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| Adebrelimab |
| Drug |
Adebrelimab 20mg/kg IV Q3W for 2 cycles, then Adebrelimab 20mg/kg IV alone Q3W until progression |
|
| Radiographic progression-free survival | Defined by radiographic progression by RECIST 1.1 for soft tissue and PCWG3 version 1.1 for bone metastases. | From baseline until progression (up to 24 months) |
| PSA progression-free survival | Time to PSA progression as defined by PCWG3 criteria. | From baseline until progression (up to 24 months) |
| PSA response rate | PSA response per PCWG3. PSA response is defined as a ≥50% decline in PSA from baseline (measured twice at least 3 weeks apart). | From baseline until progression (up to 24 months) |
| Overall survival | Overall survival (OS) is defined as time from start of study treatment to the date of death from any cause. Subjects who are alive will be censored at last follow up date. | From baseline until progression (up to 24 months) |
| Functional Assessment of Quality of life of cancer patients | Determined by the FACT-P (Functional Assessment of Cancer Therapy-Prostate) version 4. | up to 24 months |
| Fudan University Shanghai Cancer Center Xiamen Branch. | Recruiting | Xiamen | Fujian | 361000 | China |
|
| Fudan University Shanghai Cancer Center | Recruiting | Shanghai | Shanghai Municipality | 200000 | China |
|
| D013514 |
| Surgical Procedures, Operative |
| D008919 | Investigative Techniques |