SHR-1701 in Combination With Stereotactic Body Radiotherapy in mCRPC

NCT07451795 | Recruiting Phase 2

• 1 other identifier: 2509328-15
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Prostate Cancer; mCRPC (Metastatic Castration-resistant Prostate Cancer)

Outcome Measures

Primary Outcomes (1)

• Radiographic 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.

  From randomization to radiographic progression or death (up to 24 months)

Secondary Outcomes (5)

• Objective Response Rate (ORR)

  From randomization until progression (up to 24 months)

• PSA Response Rate

  From randomization until progression (up to 24 months)

• PSA Progression-Free Survival (PSA-PFS)

  From randomization until progression (up to 24 months)

• Overall Survival (OS)

  From randomization until death (up to 24 months)

• Safety and Tolerability

  up to 24 months

Other Outcomes (1)

• Immune Microenvironment Analysis

  up to 24 months

Study Arms (2)

Radiotherapy plus immunotherapy group

EXPERIMENTAL

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

Combination Product: SHR-1701 + SBRT

Radiotherapy alone group

ACTIVE COMPARATOR

Stereotactic body radiotherapy on targeted metastasis determined by MDT

Radiation: SBRT

Interventions

SHR-1701 + SBRT COMBINATION_PRODUCT

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

Radiotherapy plus immunotherapy group

SBRT RADIATION

Stereotactic body radiotherapy on targeted metastasis determined by MDT

Radiotherapy alone group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18 to 80 years old.
• Diagnosis: Histologically or cytologically confirmed adenocarcinoma of the prostate, clinically staged as metastatic prostate cancer based on conventional imaging (bone scan or CT/MRI).
• Biopsy: Whenever possible, patients should undergo a pre-treatment image-guided biopsy of a lesion; alternatively, archived biopsy tissue obtained within 30 days prior to enrollment is acceptable.
• Prior Therapy: Failure of at least one prior next-generation hormone therapy (NHT), such as abiraterone acetate, rezivilutamide, enzalutamide, apalutamide, or darolutamide.
• Chemotherapy History: Prior treatment with docetaxel, or documentation of intolerance to or refusal of chemotherapy.
• Disease Progression: Evidence of disease progression defined by: PSA progression: At least two consecutive increases in PSA levels, measured at least 1 week apart, with a screening PSA value ≥ 1 ng/mL; OR Radiographic progression in soft tissue per RECIST v1.1 (with or without PSA progression); OR Bone progression per PCWG3 criteria (occurrence of ≥ 2 new bone lesions on bone scan).
• Castration Status: Maintenance of effective and continuous luteinizing hormone-releasing hormone analog (LHRHa) therapy throughout the study period, or prior bilateral orchidectomy; serum testosterone must be maintained at castrate levels (\< 50 ng/dL).
• Performance Status: ECOG Performance Status score of 0 to 2.
• Life Expectancy: ≥ 6 months.
• Hematologic Function: Absolute neutrophil count (ANC) ≥ 1.5 ×10\^9/L; Platelets ≥ 75 ×10\^9/L; Hemoglobin ≥ 90 g/L; White blood cell (WBC) count ≥ 3.0 ×10\^9/L.
• Hepatic Function (Transaminases): Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 2.5 × upper limit of normal (ULN); for patients with liver metastases, ALT/AST ≤ 5 × ULN.
• Hepatic Function (Bilirubin): Total bilirubin ≤ 1.5 × ULN, or total bilirubin \> 1.5
• × ULN if direct bilirubin ≤ ULN.
• Coagulation Function: INR ≤ 1.5, Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN, and Prothrombin time (PT) \< ULN + 4 seconds.
• Cardiac Function: Left ventricular ejection fraction (LVEF) ≥ 50%; QTc \< 450 ms for males; serum potassium ≥ 3.5 mmol/L.

You may not qualify if:

• Concurrent Therapy: Plan to receive any other anti-tumor therapy during the study treatment period.
• Brain Metastasis: Presence of brain metastases.
• Prior Immunotherapy: Previous treatment with immune checkpoint inhibitors (including PD-1, PD-L1, CTLA-4 inhibitors, etc.) or any anti-tumor agents targeting T-cells or activating the immune system.
• Other Malignancies: Known other malignancies that are progressing or require active treatment within the past 3 years. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ that have undergone potentially curative therapy.
• Autoimmune Disease/Infection: Active autoimmune disease or active infection (including tuberculosis) requiring systemic treatment (e.g., disease-modifying drugs, corticosteroids, or immunosuppressants) within the past 2 years. Replacement therapy (e.g., thyroxine, insulin, or physiological corticosteroid replacement for adrenal/pituitary insufficiency) is not considered systemic treatment.
• Immunosuppression: Diagnosis of immunodeficiency or receipt of chronic systemic steroid therapy (doses exceeding 10 mg daily of prednisone or equivalent) or any other form of immunosuppressive therapy within 14 days prior to the first dose.
• Pneumonitis: History of (non-infectious) pneumonitis requiring steroid treatment or current non-infectious pneumonitis.
• Prior Radiation/Hormonal Washout: Receipt of radiotherapy or radionuclide therapy (e.g., Radium-223) within 28 days prior to the first dose; or abiraterone within 1 week, or other anti-androgen therapy within 2 weeks prior to the first dose.
• Hypersensitivity: Hypersensitivity or intolerance to the active ingredients or any excipients of the PD-L1 monoclonal antibody.
• Neuropsychiatric Disorders: Known history of significant neurological or psychiatric disorders, such as dementia, epilepsy, or seizure-prone conditions.
• Concomitant Conditions: Any concurrent medical condition (e.g., severe diabetes, thyroid disease, or psychiatric illness) that, in the investigator's judgment, poses a severe risk to subject safety or interferes with study completion; or any unstable medical/psychiatric condition (including laboratory abnormalities) that compromises safety or the ability to provide informed consent; or any psychological, familial, social, or geographical conditions that may affect protocol compliance and follow-up.
• Investigator's Discretion: Any other reason that the investigator deems the patient unsuitable for participation in this clinical trial.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (3)

Fujian Cancer Hospital

Fujian, China

RECRUITING

Fudan University Shanghai Cancer Center

Shanghai, China

RECRUITING

Fudan University Shanghai Cancer Center Xiamen Branch

Xiamen, China

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

SHR-1701; Radiosurgery

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Yao Zhu

CONTACT

13816751347; zhuyao@fudan.edu.cn

XuDong Ni

CONTACT

19946234803; xdni18@fudan.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 24, 2025
• First Posted: March 5, 2026
• Study Start: March 2, 2026
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)