BridgeMD
New treatment option for Prostate Cancer
Official title SHR-1701 in Combination With Stereotactic Body Radiotherapy in mCRPC
ClinicalTrials.gov ID: NCT07451795
What this study is testing
What is SHR-1701 + SBRT?
SHR-1701 + SBRT is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for prostate cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80, men only
You may be able to join if
- Age: 18 to 80 years old.
- Diagnosis: Histologically or cytologically confirmed adenocarcinoma of the prostate, clinically staged as metastatic prostate cancer based on...
- Biopsy: Whenever possible, patients should undergo a pre-treatment image-guided biopsy of a lesion; alternatively, archived biopsy tissue obtained...
- Prior Therapy: Failure of at least one prior next-generation hormone therapy (NHT), such as abiraterone acetate, rezivilutamide, enzalutamide...
- Chemotherapy History: Prior treatment with docetaxel, or documentation of intolerance to or refusal of chemotherapy.
You likely can't join 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...
- Other Malignancies: Known other malignancies that are progressing or require active treatment within the past 3 years. Exceptions include basal cell...
- Autoimmune Disease/Infection: Active autoimmune disease or active infection (including tuberculosis) requiring systemic treatment (e.g...
- Immunosuppression: Diagnosis of immunodeficiency or receipt of chronic systemic steroid therapy (doses exceeding 10 mg daily of prednisone or...
See the full eligibility criteria
Who can join
- 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...
- 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...
- 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.
- Blood Pressure: Systolic BP \< 160 mmHg and diastolic BP \< 95 mmHg; patients with stable BP after appropriate clinical management are eligible.
- Renal Function: Serum creatinine ≤ 1.5 × ULN and creatinine clearance ≥ 50 mL/min.
- Contraception: Sexually active patients with ejaculatory potential must agree to use effective contraception and refrain from sperm donation from the first dose until 3 months after the last dose of study treatment.
- Informed Consent: Ability to understand and willingness to sign a written Informed Consent Form (ICF).
- Compliance: Ability to comply with the study visit schedule and other protocol requirements.
What rules you out
- 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...
- 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...
- 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...
- 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...
- 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...
- Investigator's Discretion: Any other reason that the investigator deems the patient unsuitable for participation in this clinical trial.
The study team makes the final eligibility decision.
Where it's taking place
- Fujian, China
- Shanghai, China
- Xiamen, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fujian, China; Shanghai, China; Xiamen, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.