Maximal Cytoreductive Therapies on Post-treatment Metastases in Pts With mHSPC During Apalutamide Plus ADT Treatment

Inclusion Criteria

• •1. Able to understand and willing to sign the informed consent;
• •2. Aged ≥18 years;
• •3. Histologically or cytologically confirmed prostate adenocarcinoma (primary small cell carcinoma or signet-ring cell carcinoma of the prostate are not allowed, however adenocarcinoma with neuroendocrine differentiation accounting ≤10% is allowed);
• •4. Newly diagnosed prostate cancer (within 3 months prior to enrollment);
• •5. M1a/b disease with the presence of 1-10 visible metastases at diagnosis by conventional imagine including bone scan (ECT) and CT or MRI of the chest, abdomen, and pelvis;
• •6. With initial systemic treatment of apalutamide plus ADT and willing and expected to comply with treatment and follow up schedule \[No more than 2-month systemic treatment before enrollment (including ADT and ADT combined with short-term first-generation anti-androgen therapy (flutamide or bicalutamide); To maximize enrollment, patients who had started apalutamide plus ADT before enrollment are allowed into the study provided that they are otherwise eligible and therapy was initiated no longer than 2 months before enrollment\];
• •7. Fit to undergo cytoreductive radical prostatectomy and radiotherapy to the visible sites of metastases;
• •8. ECOG PS score is 0-1;
• •9. Adequate organ function;
• •10. Life expectancy ≥ 12 months.
• •3. Any chemotherapy;
• •4. local treatment or metastatic treatment for primary prostate cancer or metastases;
• •5. Any immunotherapy (PD-L1 etc.), target therapy (PARPi etc), etc;
• •5. History of seizure or known condition that may predispose to seizure;
• •6. History of major surgery 4 weeks before enrollment;
• •7. Had major cardiovascular and cerebrovascular diseases within 6 months prior to the start of the study;
• •8. Any condition that could interfere with drug absorption(e.g. unable to swallow, chronic diarrhea etc. );
• •9. Conditions of active infection;
• •10. History of previous or current malignant disease, except for curatively treated tumors cured for more than 3 years;
• •11. Patients who is currently undergoing other trials;
• •12. Unwilling or difficult to cooperate with treatment and follow-up visit;
• •13. Other sever conditions which could interfere with trial safety or results judged by the investigator.