[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100489194":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":32,"centralContacts":36,"locations":42,"responsibleParty":87,"collaborators":89,"id":92,"slug":93,"hasResults":94,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":98,"eligibilityCriteria":99,"healthyVolunteers":94,"sex":100,"minAge":101,"maxAge":40,"enrollmentInfo":102,"targetDuration":40,"studyType":105,"phases":106,"briefSummary":108,"conditions":109,"keywords":40,"overallStatus":75,"whyStopped":40,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},{"fullName":5,"class":6},"Fondazione IRCCS Istituto Nazionale dei Tumori, Milano","OTHER",[8,14],{"label":9,"type":6,"description":10,"interventionNames":11},"APA + ADT + RP\u002FRT","Apalutamide 240 mg, four 60 mg tablets as an oral single daily dose, according to clinical practice, plus Androgen Deprivation Therapy (ADT) plus clinician-driven choice local treatment with Radiotherapy or Radical Prostatectomy, six months after starting treatment with apalutamide",[12,13],"Drug: APA + ADT","Procedure: Local Treatmetn RT or RP",{"label":15,"type":6,"description":16,"interventionNames":17},"APA + ADT","Apalutamide 240 mg, four 60 mg tablets as an oral single daily dose, according to clinical practice, plus Androgen Deprivation Therapy (ADT)",[12],[19,25],{"type":20,"name":15,"description":21,"armGroupLabels":22,"otherNames":23},"DRUG","All participants will receive apalutamide 240 mg (4 x 60 mg) tablets orally once daily. Apalutamide is distributed in Italy under the trade name of Erleada® 60 mg.\n\nAll patients not undergoing surgical castration should also continue medical castration by taking a gonadotropin-releasing hormone (GnRHa) analogue during treatment.",[15,9],[24],"Apalutamide 240 mg + Androgen Deprivation Therapy",{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"PROCEDURE","Local Treatmetn RT or RP","Patients who will undergo radiotherapy as a local treatment must be treated according to the following scheme:\n\nExternal beam radiotherapy administered at 36 Gy in six consecutive weekly fractions of 6 Gy, or 55 Gy in 20 daily fractions of 2・75 Gy over 4 weeks.\n\nRadiation therapy will be given with the patient supine and with a full bladder and an empty rectum. The planned target volume is prostate only, with an 8 mm margin posteriorly and a 10 mm margin elsewhere.\n\nNo RT on lymph nodes is foreseen. RT should begin 6 months after the first dose of apalutamide (+\u002F- 2 weeks).\n\nRadical prostatectomy should be performed 6 months after the first dose of apalutamide (+\u002F- 2 weeks).",[9],[31],"Local treatment with radiotherapy or radical prostatectomy, clinician-driven choice",[33],{"name":34,"affiliation":5,"role":35},"Valentina Guadalupi, MD","PRINCIPAL_INVESTIGATOR",[37],{"name":34,"role":38,"phone":39,"phoneExt":40,"email":41},"CONTACT","00390223903811",null,"valentina.guadalupi@istitutotumori.mi.it",[43,62,73],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"European Institute of Oncology","NOT_YET_RECRUITING","Milan","Lombardy","20141","Italy","IT",{"type":52,"coordinates":53},"Point",[54,55],9.18951,45.46427,{"lat":55,"lon":54},[58,61],{"name":59,"role":38,"phone":40,"phoneExt":40,"email":60},"Barbara Alicja Jereczek, MD","barbara.jereczek@ieo.it",{"name":59,"role":35,"phone":40,"phoneExt":40,"email":40},{"facility":63,"status":45,"city":46,"state":47,"zip":64,"country":49,"countryCode":50,"cosmosGeoPoint":65,"geoPoint":67,"contacts":68},"ASST Santi Paolo e Carlo","20153",{"type":52,"coordinates":66},[54,55],{"lat":55,"lon":54},[69,72],{"name":70,"role":38,"phone":40,"phoneExt":40,"email":71},"Bernardo Rocco, MD","bernardo.rocco@gmail.com",{"name":70,"role":35,"phone":40,"phoneExt":40,"email":40},{"facility":74,"status":75,"city":46,"state":76,"zip":77,"country":49,"countryCode":50,"cosmosGeoPoint":78,"geoPoint":80,"contacts":81},"Istituto Tumori Milano","RECRUITING","Mi","20156",{"type":52,"coordinates":79},[54,55],{"lat":55,"lon":54},[82,84,86],{"name":34,"role":38,"phone":83,"phoneExt":40,"email":41},"+390223902811",{"name":85,"role":38,"phone":40,"phoneExt":40,"email":40},"MD",{"name":34,"role":35,"phone":40,"phoneExt":40,"email":40},{"type":88,"investigatorFullName":40,"investigatorTitle":40,"investigatorAffiliation":40,"oldNameTitle":40,"oldOrganization":40},"SPONSOR",[90,91],{"name":63,"class":6},{"name":44,"class":6},"100489194","multimodal-approach-in-patients-with-mhspc-randomized-trial-of-apaadt-vs-apa-adt-and-local-treatment-100489194",false,"NCT05649943","Multimodal Approach in Patients With mHSPC. Randomized Trial of APA+ADT vs APA-ADT and Local Treatment","APPROACH : Multimodal Approach in Patients With mHSPC. A Pragmatic Randomized Trial of Apalutamide Plus Androgen Deprivation Therapy (APA-ADT) Versus APA-ADT Plus Local Treatment. A Meet-URO 29 Study","APPROACH","Inclusion Criteria:\n\n* Age \\> 18\n* Histologically confirmed diagnosis of prostate adenocarcinoma\n* Metastatic disease documented by ≥1 bone lesion with Technetium 99m (99mTc) bone scan. Individuals with only one bone lesion should have confirmation of that lesion on CT or MRI.\n* Eastern Cooperative Oncology Group Performance Status (ECOG PS) Grade ≤ 2\n* No previous treatment with antiandrogens or GnRH analogues, or a treatment ≤ 3 months.\n* No previous systemic or local treatment for prostate adenocarcinoma, including pelvic radiotherapy.\n* Laboratory values at the time of screening:\n\n  a. Neutrophils ≥ 1500\u002FμL b. Hemoglobin ≥ 9.0 mg\u002FμL (no transfusions in the past 28 days) c. Platelets ≥ 100,000\u002FμL d. Creatinine ≤ 2 x upper limit of normal and serum albumin ≥ 3.0 g\u002FdL f. Total bilirubin ≤ 1.5 x upper limit of normal \\[NOTE: In subjects with Gilbert syndrome, if total bilirubin is \\>1.5 x ULN, measure direct and indirect bilirubin, and if direct bilirubin is ≤ 1.5 x ULN subjects may be eligible\\]; g. AST and ALT ≤ 2.5 x upper limit of normal\n* Able to swallow Apalutamide tablets whole.\n* All subjects must sign an Informed Consent Form indicating that they understand the purpose of the study and its procedures and intend to participate. The subject must be willing and must be able to comply with the restrictions specified in this protocol.\n\nInclusion criteria for cytoreductive surgery:\n\n* Age \\>18 years\n* Clinical stage cT3\n* Robot-assisted radical prostatectomy with iliac obturator lymphadenectomy\n* Surgical piece management criteria similar to Proteus criteria.\n\nExclusion Criteria:\n\n* Pathologic findings consistent with small cell, ductal, or neuroendocrine prostate cancer.\n* Known brain metastases.\n* Lymph node metastases only.\n* Visceral metastases.\n* Patients not eligible for surgery or radiotherapy.\n* Unacceptable increase in cardiovascular risk, defined as the occurrence of at least one of the following episodes in the 6 months prior to randomization: unstable angina, myocardial infarction, symptomatic congestive heart failure, clinically significant thromboembolic events (e.g., pulmonary embolism), or clinically significant ventricular arrhythmias .\n* Uncontrolled high blood pressure (systolic blood pressure \\> 160 mmHg or diastolic blood pressure \\> 100 mmHg).\n* Previous treatment with antiandrogens, GnRH analogues, or other systemic treatments for adenocarcinoma of the prostate.\n* Previous local treatment with surgery and\u002For radiotherapy.\n* Any prior malignancy (except adequately treated basal cell carcinoma or a squamous cell skin carcinoma, superficial bladder carcinoma, or any other in situ carcinoma currently in complete remission) within 5 years of randomization.\n* Known allergies, hypersensitivity or intolerance to the excipients of Apalutamide.\n* Patients who, within 28 days prior to randomisation, have received:\n\n  1. transfusions (red blood cells and\u002For platelets);\n  2. hematopoietic growth factors;\n  3. major surgery.\n* Symptomatic and\u002For chronic viral hepatitis; chronic liver disease; moderate or severe liver failure (class B and C according to the Child-Pugh scale); encephalopathy, ascites or thrombo-haemorrhagic disorders secondary to liver failure.\n* Gastrointestinal disorders affecting drug absorption\n* Active infections requiring systemic therapy such as human immunodeficiency virus (HIV);\n* Any condition or situation which, in the judgment of the investigator, precludes participation in this trial.\n\nExclusion criteria for cytoreductive surgery:\n\n* Contraindication for surgery","MALE","18 Years",{"count":103,"type":104},566,"ESTIMATED","INTERVENTIONAL",[107],"NA","Italian multicenter study, will enroll \\~566 pts with oligometastatic hormone sensitive prostate cancer who are candidates to receive treatment with apalutamide.\n\nAfter 6 months from the start of treatment, patients will be randomized to receive local treatment based on the investigator's choice ( either one between primary radiotherapy or cytoreductive prostatectomy), in addition to apalutamide, or to continue just with medical therapy.",[110],"Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)","2025-09-02",{"date":113,"type":114},"2025-09-03","ACTUAL",{"date":116,"type":114},"2023-03-01",{"date":118,"type":104},"2029-01-01",{"name":5,"class":6},3]