Phase
Condition
Prostate Cancer
Metastatic Cancer
Urologic Cancer
Treatment
TURP
Standard Medical Therapy
Clinical Study ID
Ages 18-80 Male
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients must voluntarily agree to participate and provide signed informed consent.
aged 18 to 80 years.
Pathologically or cytologically confirmed adenocarcinoma of the prostate, withneuroendocrine differentiation components ≤10%, and no small cell or signet ringcell carcinoma histological features.
Newly diagnosed metastatic prostate cancer with evidence of metastasis (lymph node,bone, or visceral metastases) confirmed by PSMA/PET-CT, CT, or MRI.
Patients must not have participated in or plan to participate in another clinicaltrial.
ECOG PS score of 0-1.
Adequate Organ and Bone Marrow Function:
- Absolute neutrophil count (ANC) ≥ 1.5×10⁹/L (1500/μL).
- Hemoglobin ≥ 90 g/L (9.0 g/dL).
- Platelet count ≥ 80×10⁹/L (100,000/μL).
- Liver function: total bilirubin ≤ 1.5×ULN, AST/ALT and alkalinephosphatase ≤ 2.5×ULN. Ⅴ. Kidney function: serum creatinine ≤ 2×ULN or calculatedcreatinine clearance ≥ 30 mL/min. Ⅵ. Coagulation function: INR ≤ 1.5.
Exclusion
Exclusion Criteria:
History of hypersensitivity or intolerance to any of the drugs used in the study.
Patients diagnosed with metastatic castration-resistant prostate cancer (mCRPC) whohave already undergone TURP and do not present with lower urinary tract obstructionor hematuria.
Oligometastatic mHSPC Patients: Patients with oligometastatic hormone-sensitiveprostate cancer (mHSPC) who are planning to undergo radical prostatectomy as theprimary treatment.
Patients with significant contraindications to TURP, such as severe urethralstricture or inability to catheterize.
History of seizures or medications known to lower the seizure threshold, or anydisease that may induce seizures (e.g., stroke or transient ischemic attacks) within 12 months prior to the study.
Recent Major Surgery: Patients who have undergone major surgery within 4 weeksbefore starting the study treatment.
History of severe or unstable cardiovascular disease within the last 6 months,including severe angina, myocardial infarction, congestive heart failure (NYHA IIIor higher), cerebrovascular accident, or requiring medication for arrhythmia.
Severe Digestive Disorders: Patients with chronic diarrhea, bowel obstruction, orother factors affecting drug absorption.
Patients with active infections, including HIV, hepatitis B (HBsAg-positive), orhepatitis C, that may affect the safety and efficacy of the treatment.
Patients diagnosed with other malignancies in the past 3 years, excluding curedbasal cell carcinoma of the skin.
Patients with active brain metastases or leptomeningeal disease.
Patients currently receiving any investigational drugs or devices.
Patients who are unlikely to comply with the treatment protocol and follow-upschedule.
Any condition that the investigator believes could compromise the patient's safetyor interfere with the study results (e.g., uncontrolled hypertension, severediabetes, psychiatric conditions).
Study Design
Connect with a study center
Fudan University Shanghai Cancer Center
Shanghai, Shanghai 200032
ChinaActive - Recruiting
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