prostate cancer
Conditions
Interventions
Initial diagnosis of oligometastasis: Patients with <= 5 metastatic lesions (limited to the axial skeleton, excluding soft tissue metastases) who meet the criteria for surgical treatment.:Patients wit
Endocrine therapy only: Patients who meet the criteria for endocrine therapy but are not suitable for surgical treatment (e.g., excessive number of metastatic lesions or presence of other severe comor
Multiple metastases to oligometastases: Patients with multiple metastases transition to an oligometastatic state (<=5 metastatic lesions) after endocrine therapy.:After endocrine therapy, researchers
Sponsors
Department of Urology, The First Hospital of Shanxi Medical University
Eligibility
Sex/Gender
Male
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Pathological or clinical evidence indicates prostate cancer. 2. Diagnosis of oligometastatic prostate cancer: Confirmed as oligometastatic patients (typically defined as =110 g/L; Platelets (PLT) >=80×10^9/L; Absolute neutrophil count (ANC) >=1.5×10^9/L; White blood cell count (WBC) =3.0×10^9/L; Lymphocytes >=0.5×10^9/L; Alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP) =30 g/L; Serum creatinine =50 mL/minute (using the Cockcroft/Gault formula); Activated partial thromboplastin time (APTT), International Normalized Ratio (INR), Prothrombin time (PT) =3.5 mmol/L. 5. Suitable for surgical treatment: Patients deemed suitable for surgery after endocrine therapy by the investigator, with <=5 metastatic lesions, excluding soft tissue (liver, lung, brain) metastases, and limited to the axial skeleton, may undergo radical prostatectomy. 6. Postoperative adjuvant local radiotherapy is feasible: The investigator determines that the patient is suitable for postoperative adjuvant local radiotherapy. 7. Patient consent to participate in the study: The patient is informed, consents, and is willing to participate in the study, signing the informed consent form. The patient agrees to follow-up at 1 month, 3 months, 6 months, and 12 months post-surgery, every 3 months in the second year, and every 6 months in the third and fourth years post-surgery.
Exclusion criteria
Exclusion criteria: 1. Excessive number of metastatic lesions: Diagnosed with multiple metastases (usually defined as more than 5 metastatic lesions) based on imaging studies (PSMA PET/CT, MRI, whole-body bone scan), with imaging evidence of liver or (and) lung or (and) brain tumor lesions. 2. Severe comorbidities: Presence of severe cardiovascular diseases (e.g., left ventricular ejection fraction (LVEF) = 70%, etc.), severe hypertension (>180/110 mmHg with acute hypertensive crisis or target organ damage, etc.), hepatic or renal dysfunction (ALT, AST > 5 times the normal value, liver enzymes > 1000 U/L), with coagulation disorders (INR > 1.5 and/or hepatic encephalopathy, eGFR = 1.5 times baseline, urine output =8%, diabetic retinopathy, diabetic nephropathy, diabetic neuropathy, diabetic ketoacidosis, etc.), history of cerebral ischemia, stroke, traumatic brain injury with impaired consciousness, etc., affecting surgical and recovery conditions, severe fractures or spinal compression in patients with bone metastases, posing serious risks to patient safety, making surgery or radiation therapy unfeasible. 3. Patients deemed unsuitable for surgery by the investigator, those unable to undergo surgery or unwilling to accept surgery, and those who have not signed informed consent. 4. Patients scheduled to undergo bilateral orchiectomy during the study period. 5. Other malignancies: History of malignancies in other sites that may affect the interpretation of study results, except for completely resolved in situ cancers and malignancies deemed to progress slowly by the investigator. 6. Active hepatitis B (positive hepatitis B surface antigen with HBV DNA >=500 IU/mL or 2500 copies/mL) or hepatitis C (positive hepatitis C antibody with HCV RNA above the upper limit of normal). 7. History of immunodeficiency (including positive HIV test, other acquired or congenital immunodeficiency diseases) or organ transplantation. 8. Other situations deemed unsuitable for inclusion in the study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival of PSA;Overall Survival);Local Recurrence Rate;Distant Metastasis-Free Survival;Treatment-Related Complications; | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of Life;Tumor markers; | — |
Countries
China
Contacts
Public ContactWu Bo
Department of Urology, The First Hospital of Shanxi Medical University
Outcome results
None listed