The aim of this study is to evaluate the efficacy of SHR-1701 in combination with SBRT 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
66
Stereotactic body radiotherapy on targeted metastasis determined by MDT + SHR1701 30mg/kg IV every 3 weeks (Q3W) for 2 cycles, then SHR1701 alone Q3W until progression
Stereotactic body radiotherapy on targeted metastasis determined by MDT
Fujian Cancer Hospital
Fujian, China
RECRUITINGFudan University Shanghai Cancer Center
Shanghai, China
RECRUITINGFudan University Shanghai Cancer Center Xiamen Branch
Xiamen, China
RECRUITINGRadiographic Progression-Free Survival (rPFS)
Description: Defined as bone disease progression (occurrence of two or more new lesions on bone scan) per PCWG3, or soft tissue/clinical progression per RECIST v1.1.
Time frame: From randomization to radiographic progression or death (up to 24 months)
Objective Response Rate (ORR)
The proportion of patients with a best overall response of Complete Response (CR) or Partial Response (PR), as assessed by RECIST v1.1 and PCWG3 criteria.
Time frame: From randomization until progression (up to 24 months)
PSA Response Rate
The proportion of patients achieving a ≥ 50% reduction in serum PSA from baseline, confirmed by a second measurement at least 3 weeks later.
Time frame: From randomization until progression (up to 24 months)
PSA Progression-Free Survival (PSA-PFS)
Defined according to PCWG3 criteria as: (1) For patients with a decline from baseline: A ≥ 25% increase in PSA and an absolute increase of ≥ 2 ng/mL above the nadir, confirmed by a second measurement at least 3 weeks later; (2) For patients without a decline from baseline: A ≥ 25% increase in PSA and an absolute increase of ≥ 2 ng/mL from baseline after at least 12 weeks of intervention. Subjects with PSA progression alone in the absence of symptomatic or radiographic progression may continue treatment at the investigator's discretion if clinical benefit is perceived.
Time frame: From randomization until progression (up to 24 months)
Overall Survival (OS)
Defined as the time from enrollment to death from any cause.
Time frame: From randomization until death (up to 24 months)
Safety and Tolerability
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The National Cancer Institute-Common Terminology Criteria for Adverse Events version 5 (NCI-CTCAE v5) is widely accepted in the community of oncology research as the leading rating scale for adverse events. This scale, divided into 5 grades (1 = "mild", 2 = "moderate", 3 = "severe", 4 = "life-threatening", and 5 = "death") determined by the investigator, will make it possible to assess the severity of the disorders.
Time frame: up to 24 months