[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100494392":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":23,"centralContacts":23,"locations":38,"responsibleParty":68,"collaborators":23,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":73,"sex":79,"minAge":80,"maxAge":23,"enrollmentInfo":81,"targetDuration":23,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":23,"overallStatus":91,"whyStopped":23,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Fudan University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"maximal-cytoreductive therapy","EXPERIMENTAL","Patients with de novo mCSPC who achieve ≤10 oligopersistent metastases on PSMA PET CT after initial 3-month systemic treatment with apalutamide plus ADT will receive cytoreductive radical prostatectomy with\u002Fwithout PLND and metastasis-directed therapy with radiation.",[13,14,15,16],"Drug: apalutamide","Drug: androgen deprivation therapy","Procedure: cytoreductive radical prostatectomy with\u002Fwithout pelvic lymph node dissection","Radiation: metastasis-directed therapy with radiation",[18,24,28,33],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"DRUG","apalutamide","Patients receive apalutamide 240mg,qd,po.",[9],null,{"type":19,"name":25,"description":26,"armGroupLabels":27,"otherNames":23},"androgen deprivation therapy","Patients receive systemic ADT.",[9],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":23},"PROCEDURE","cytoreductive radical prostatectomy with\u002Fwithout pelvic lymph node dissection","Patients receive cytoreductive radical prostatectomy with\u002Fwithout pelvic lymph node dissection.",[9],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":23},"RADIATION","metastasis-directed therapy with radiation","Patients receive metastasis-directed therapy with radiation guided by post-treatment oligopersistent metastases.",[9],[39,52],{"facility":40,"status":23,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":23},"Fudan University Shanghai Cancer Center Pudong Hospital","Shanghai","Shanghai Municipality","200000","China","CN",{"type":47,"coordinates":48},"Point",[49,50],121.45806,31.22222,{"lat":50,"lon":49},{"facility":53,"status":23,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":54,"geoPoint":56,"contacts":57},"Fudan University Shanghai Cancer Center Xuhui Hospital",{"type":47,"coordinates":55},[49,50],{"lat":50,"lon":49},[58,63,66],{"name":59,"role":60,"phone":61,"phoneExt":23,"email":62},"Beihe Wang, M.D.","CONTACT","+8602164135590","med_wangbh@163.com",{"name":64,"role":65,"phone":23,"phoneExt":23,"email":23},"Yao Zhu, M.D.","PRINCIPAL_INVESTIGATOR",{"name":59,"role":67,"phone":23,"phoneExt":23,"email":23},"SUB_INVESTIGATOR",{"type":65,"investigatorFullName":69,"investigatorTitle":70,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"Ding-Wei Ye","Prof.","100494392","phase-2-maximal-cytoreductive-therapies-on-post-treatment-metastases-in-pts-with-mhspc-during-apalutamide-plus-adt-treatment-100494392",false,"NCT05717582","Maximal Cytoreductive Therapies on Post-treatment Metastases in Pts With mHSPC During Apalutamide Plus ADT Treatment","A Prospective Study of Maximal-Cytoreductive Therapies for Patients With de Novo Metastatic Hormone-sensitive Prostate Cancer Who Achieve Oligopersistent Metastases During Systemic Treatment With Apalutamide Plus ADT (CHAMPION Study)","CHAMPION","Inclusion Criteria:\n\n1. Able to understand and willing to sign the informed consent;\n2. Aged ≥18 years;\n3. 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);\n4. Newly diagnosed prostate cancer (within 3 months prior to enrollment);\n5. M1a\u002Fb 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;\n6. 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\\];\n7. Fit to undergo cytoreductive radical prostatectomy and radiotherapy to the visible sites of metastases;\n8. ECOG PS score is 0-1;\n9. Adequate organ function;\n10. Life expectancy ≥ 12 months.\n\nExclusion Criteria:\n\n1. History of allergies, hypersensitivity, or intolerance to any drug used in the study;\n2. Had the contraindications or is intolerant to cRP or RT;\n3. Had any visceral metastases (brain, liver, lung etc.) on screening conventional imaging (bone scans, CT or MRI);\n4. Prior Received any of the following treatments for primary and metastatic prostate cancer;\n\n   1. \\>2-month ADT or first-generation antiandrogens (bicalutamide, flutamide etc.);\n   2. Any other novel hormonal therapies (enzalutamide, darolutamide, abiraterone etc.) except ≤ 2-month apalutamide plus ADT listed in inclusion criteria;\n   3. Any chemotherapy;\n   4. local treatment or metastatic treatment for primary prostate cancer or metastases;\n   5. Any immunotherapy (PD-L1 etc.), target therapy (PARPi etc), etc;\n5. History of seizure or known condition that may predispose to seizure;\n6. History of major surgery 4 weeks before enrollment;\n7. Had major cardiovascular and cerebrovascular diseases within 6 months prior to the start of the study;\n8. Any condition that could interfere with drug absorption(e.g. unable to swallow, chronic diarrhea etc. );\n9. Conditions of active infection;\n10. History of previous or current malignant disease, except for curatively treated tumors cured for more than 3 years;\n11. Patients who is currently undergoing other trials;\n12. Unwilling or difficult to cooperate with treatment and follow-up visit;\n13. Other sever conditions which could interfere with trial safety or results judged by the investigator.","MALE","18 Years",{"count":82,"type":83},47,"ESTIMATED","INTERVENTIONAL",[86],"PHASE2","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\u002Fwithout 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.",[89,90],"Metastatic Prostate Cancer","Castration-Sensitive Prostate Cancer","NOT_YET_RECRUITING","2023-02-04",{"date":94,"type":95},"2023-02-08","ACTUAL",{"date":97,"type":83},"2023-05-01",{"date":99,"type":83},"2026-12-31",{"name":5,"class":6},2]