Hormone-sensitive prostate cancer with limited metastasis
Conditions
Interventions
Experimental group:Prostate Cell Decimation Combined with ADT + Darolutamide + Docetaxel
Sponsors
The First Affiliated Hospital of Sun Yat-sen University
Eligibility
Sex/Gender
Male
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Males aged 18–85 years; 2. Histologically or cytologically confirmed prostate adenocarcinoma; 3. Oligometastatic disease diagnosed by CT, MRI, or bone scan as M1a and/or M1b, with =5 bone metastases, with or without cN positive. Patients with only regional lymph node metastasis (N1, below the aortic bifurcation) do not meet the study criteria; 4. According to the investigator's judgment, patients must meet the indications for ADT and docetaxel; 5. Patients have not previously received local or systemic treatment for primary or metastatic prostate cancer; 6. ECOG score 0–1; 7. Screening blood counts: hemoglobin >= 9.0 g/dL, absolute neutrophil count >= 1.5 × 10^9/L, platelet count >=100 × 10^9/L (patients have not received colony-stimulating factor therapy within 4 weeks before blood collection, or blood/blood products within 7 days); serum alanine aminotransferase and/or aspartate aminotransferase <=1.5 × upper limit of normal (ULN), total bilirubin <= ULN, creatinine <= 2.0 × ULN.
Exclusion criteria
Exclusion criteria: 1. Previous treatments: ADT, second-generation androgen receptor inhibitors, CYP17 enzyme inhibitors, any chemotherapy or immunotherapy for prostate cancer, radiotherapy (external beam radiotherapy, brachytherapy, or radiopharmaceuticals); 2. Known allergy to any investigational drug or excipient in the formulation; 3. Presence of visceral metastases; 4. Any of the following within 6 months prior to randomization: stroke, myocardial infarction, severe or unstable angina, coronary or peripheral arterial bypass surgery, or congestive heart failure (NYHA Class III or IV); 5. History of malignancy, except for basal cell carcinoma or fully resolved squamous cell carcinoma of the skin; 6. Gastrointestinal disease or surgical history expected to significantly interfere with the absorption of the investigational drug; 7. Active acute or chronic viral hepatitis, known HIV infection; 8. Participation in another clinical study of an investigational drug; 9. Other serious or unstable health conditions that may affect participation in the study, evaluation of study results, or may pose a risk to trial safety; 10. Inability to swallow oral medications.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of progression to CRPC within 1 year; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pathological complete remission rate;PSA undetectable rate (<=0.2 ng/mL) at 6, 12, and 24 months post-surgery;Time to progression to castration-resistant prostate cancer;Circulating Tumor Cell Assay; | — |
Countries
China
Contacts
Public ContactJunxing Chen
The First Affiliated Hospital of Sun Yat-sen University
Outcome results
None listed