[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100470307":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":30,"centralContacts":39,"locations":45,"responsibleParty":72,"collaborators":74,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":80,"sex":86,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":30,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":30,"overallStatus":48,"whyStopped":30,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"University Health Network, Toronto","OTHER",[8,13,19],{"label":9,"type":6,"description":10,"interventionNames":11},"Arm 1 - Standard of Care","Participants in this group will receive standard of care radiation treatment and ADT. Participants will start ADT first. Androgen deprivation therapy will be delivered via injection every 3-4 months as per standard of care (for 8-9 months total). At the same time, or within 3 months of starting ADT, participants will begin radiation treatment. The radiation treatment course will consist of 2-5 sessions of radiation daily or every other day (the number of sessions will be determined by the physician depending on the location of cancer, number of cancer spots, etc.).",[12],"Other: Standard of Care SBRT and ADT",{"label":14,"type":15,"description":16,"interventionNames":17},"Arm 3 - Study Treatment (Abiraterone)","EXPERIMENTAL","Participants in this group will receive standard of care radiation treatment and ADT, plus abiraterone. Participants will start ADT first. Androgen deprivation therapy will be delivered via injection every 3-4 months as per standard of care (for 8-9 months total). At the same time, or within 3 months of starting ADT, participants will begin radiation treatment. The radiation treatment course will consist of 2-5 sessions of radiation daily or every other day (the number of sessions will be determined by the physician depending on the location of cancer, number of cancer spots, etc.). In addition, participants will take abiraterone orally (by mouth) daily for 8-9 months. Participants will start the first pill within a month of enrollment. This pill can be taken around the same time of day with or without food.",[18,12],"Drug: Abiraterone",{"label":20,"type":15,"description":21,"interventionNames":22},"Arm 4: Study Treatment (Abiraterone + Atorvastatin)","Participants in this group will receive standard of care radiation treatment and ADT, plus abiraterone and atorvastatin. Participants will start ADT first. Androgen deprivation therapy will be delivered via injection every 3 or 4 months as per standard of care (for 8-9 months total). At the same time, or within 3 months of starting ADT, participants will begin radiation treatment. The radiation treatment course will consist of 2-5 sessions of radiation daily or every other day (the number of sessions will be determined by the physician depending on the location of cancer, number of cancer spots, etc.). In addition, participants will take abiraterone orally (by mouth) daily for 8-9 months. Participants will start the first pill within a month of enrollment. This pill can be taken around the same time of day with or without food. Participants will also take atorvastatin once daily by mouth for 2 years. This may also be taken with or without food.",[18,12,23],"Drug: Atorvastatin",[25,31,35],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","Abiraterone","Second-generation androgen pathway inhibitor (ARAT), oral tablet",[14,20],null,{"type":6,"name":32,"description":33,"armGroupLabels":34,"otherNames":30},"Standard of Care SBRT and ADT","Standard of care stereotactic body radiation therapy (SBRT) and androgen deprivation therapy (ADT)",[9,14,20],{"type":26,"name":36,"description":37,"armGroupLabels":38,"otherNames":30},"Atorvastatin","Lipid metabolism regulator",[20],[40],{"name":41,"role":42,"phone":43,"phoneExt":30,"email":44},"Rachel Glicksman, MD","CONTACT","416-946-4961","rachel.glicksman@uhn.ca",[46,64],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Princess Margaret Cancer Center","RECRUITING","Toronto","Ontario","M5G 2M9","Canada","CA",{"type":55,"coordinates":56},"Point",[57,58],-79.39864,43.70643,{"lat":58,"lon":57},[61],{"name":41,"role":42,"phone":62,"phoneExt":63,"email":44},"416-946-4501","4483",{"facility":65,"status":66,"city":49,"state":67,"zip":68,"country":52,"countryCode":53,"cosmosGeoPoint":69,"geoPoint":71,"contacts":30},"Sunnybrook Research Institute","ACTIVE_NOT_RECRUITING","Ontartio","M4N 3M5",{"type":55,"coordinates":70},[57,58],{"lat":58,"lon":57},{"type":73,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR",[75],{"name":76,"class":77},"Astellas Pharma Inc","INDUSTRY","100470307","phase-2-duration-of-androgen-receptor-pathway-inhibitor-and-adt-with-metastasis-directed-therapy-in-oligometastatic-cancer-of-the-prostate-direct-100470307",false,"NCT05404139","Duration of Androgen Receptor Pathway Inhibitor and ADT With Metastasis Directed Therapy in Oligometastatic Cancer of the Prostate (DIRECT)","Duration of Androgen Receptor Pathway Inhibitor and ADT With Metastasis Directed Therapy in Oligometastatic Cancer of the Prostate","DIRECT","Inclusion Criteria:\n\n1. Age \\> 18 years\n2. Able to provide informed consent\n3. Histologic diagnosis of prostate adenocarcinoma\n4. ECOG performance status 0-2\n5. Stage IV castrate sensitive metachronous metastatic prostate cancer. diagnosed within 6 months of study enrollment with 1-10 metastases\n\n   1. Maximum one metastatic deposit on conventional imaging (CT or bone scan or MR)\n   2. Additional metastases can be detectable by PSMA PET only\n6. All sites of disease are amenable to and can be safely treated with radiotherapy\n7. Patients decline continuous use of ADT\n\nExclusion Criteria (for all patients):\n\n1. Significant comorbidities rendering patient not suitable for ADT, ARPI (enzalutamide or abiraterone) and SBRT\n\n   a. Patients with significant comorbidities rendering patient not suitable for atorvastatin is not an exclusion criteria, as these patients can still enroll and be randomized between Arms 1 and 3.\n2. History of malignancy within the past 5 years, excluding non-melanoma skin cancer and in-situ cancer, managed non-curatively\n3. Prior use of salvage systemic therapy\n4. Evidence of spinal cord compression\n\nExclusion Criteria (for Arm 4 only, after randomization)\n\n1. ALT\u002FAST \\> 3 x ULN\n2. History of myasthenia gravis or active myasthenia gravis\n3. History of ocular myasthenia or active ocular myasthenia","MALE","18 Years","100 Years",{"count":90,"type":91},352,"ESTIMATED","INTERVENTIONAL",[94],"PHASE2","This is a multi-centre, investigator-initiated, three-arm, randomized trial to investigate the addition on androgen receptor pathway inhibitor and atorvastatin to standard of care radiation and hormone therapy improve quality of life.\n\nParticipants will either receive standard of care radiation and hormone (ADT) therapy (Arm 1), standard of care radiation and hormone (ADT) therapy plus oral abiraterone for 8-9 months (Arm 3) or standard of care radiation and hormone (ADT) therapy plus oral abiraterone for 8-9 months plus atorvastatin for 2 years (Arm 4). Participants will be routinely follow-up in clinic or remotely for up to 5 years.",[97],"Metastatic Prostate Cancer","2026-07-23",{"date":100,"type":101},"2026-07-27","ACTUAL",{"date":103,"type":101},"2023-05-24",{"date":105,"type":91},"2031-02",{"name":5,"class":6},2]