maximal cytoreductive therapies on post-treatment metastases in pts with mhspc during apalutamide plus adt treatment

Conditions: Metastatic Prostate Cancer; Castration-Sensitive Prostate Cancer

Summary: to assess the feasibility and safety of maximal cytoreductive therapies in patients with de novo mcspc who achieve ≤10 oligopersistent metastases on psma pet ct after initial 3-month systemic treatment with apalutamide plus adt. maximal cytoreductive therapies consist of 1.cytoreductive radical prostatectomy with/without plnd guided by post-treatment pet 2.metastasis-directed therapy with radiation guided by post-treatment oligopersistent metastases. all patients receive continuous systemic treatment with apalutamide plus adt.


Eligibility criteria:
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. exclusion criteria: 1. history of allergies, hypersensitivity, or intolerance to any drug used in the study; 2. had the contraindications or is intolerant to crp or rt; 3. had any visceral metastases (brain, liver, lung etc.) on screening conventional imaging (bone scans, ct or mri); 4. prior received any of the following treatments for primary and metastatic prostate cancer; 1. \>2-month adt or first-generation antiandrogens (bicalutamide, flutamide etc.); 2. any other novel hormonal therapies (enzalutamide, darolutamide, abiraterone etc.) except ≤ 2-month apalutamide plus adt listed in inclusion criteria; 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.