[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100647670":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":29,"centralContacts":45,"locations":51,"responsibleParty":74,"collaborators":29,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":78,"sex":84,"minAge":85,"maxAge":29,"enrollmentInfo":86,"targetDuration":29,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":95,"overallStatus":109,"whyStopped":29,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},{"fullName":5,"class":6},"AstraZeneca","INDUSTRY",[8,17],{"label":9,"type":10,"description":11,"interventionNames":12},"Saruparib (AZD5305) + Physician's Choice ARPI - enzalutamide, darolutamide, or abiraterone","EXPERIMENTAL","Saruparib 60 mg + ARPI (enzalutamide, darolutamide, or abiraterone) : Participants will receive saruparib 60 mg orally once daily in combination with physician's choice of ARPI in cycles of 28 days",[13,14,15,16],"Drug: Saruparib","Drug: Enzalutamide","Drug: Darolutamide","Drug: Abiraterone",{"label":18,"type":19,"description":20,"interventionNames":21},"Placebo + Physician's Choice ARPI - enzalutamide, darolutamide, or abiraterone","PLACEBO_COMPARATOR","Placebo + ARPI (enzalutamide, darolutamide, or abiraterone): Participants will receive placebo orally once daily in combination with physician's choice of ARPI in cycles of 28 days",[22,14,15,16],"Other: Placebo",[24,30,35,39,42],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DRUG","Saruparib","Arm 1: Saruparib (AZD5305) + Physician's Choice ARPI (enzalutamide, darolutamide, or abiraterone)",[9],null,{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":29},"OTHER","Placebo","Arm 2: Placebo + Physician's Choice ARPI (enzalutamide, darolutamide, or abiraterone)",[18],{"type":25,"name":36,"description":37,"armGroupLabels":38,"otherNames":29},"Enzalutamide","Arm 1: Saruparib (AZD5305) + Physician's Choice ARPI (enzalutamide, darolutamide, or abiraterone) Arm 2: Placebo + Physician's Choice ARPI",[18,9],{"type":25,"name":40,"description":37,"armGroupLabels":41,"otherNames":29},"Darolutamide",[18,9],{"type":25,"name":43,"description":37,"armGroupLabels":44,"otherNames":29},"Abiraterone",[18,9],[46],{"name":47,"role":48,"phone":49,"phoneExt":29,"email":50},"AstraZeneca Clinical Study Information Center","CONTACT","1-877-240-9479","information.center@astrazeneca.com",[52,65],{"facility":53,"status":29,"city":54,"state":55,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":29},"Research Site","Ottawa","Ontario","K1H 7W9","Canada","CA",{"type":60,"coordinates":61},"Point",[62,63],-75.69812,45.41117,{"lat":63,"lon":62},{"facility":53,"status":29,"city":66,"state":67,"zip":68,"country":57,"countryCode":58,"cosmosGeoPoint":69,"geoPoint":73,"contacts":29},"Montreal","Quebec","H2X 0A9",{"type":60,"coordinates":70},[71,72],-73.58781,45.50884,{"lat":72,"lon":71},{"type":75,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR","100647670","phase-3-saruparib-in-combination-with-physicians-choice-of-arpi-in-patients-with-mhspc-previously-treated-with-docetaxel-or-177lu-psma-therapy-without-disease-progression-and-psa--02-ngml-evopar-pr05-100647670",false,"NCT07711002","Saruparib in Combination With Physician's Choice of ARPI in Patients With mHSPC Previously Treated With Docetaxel or 177Lu-PSMA Therapy Without Disease Progression and PSA ≥ 0.2 ng\u002FmL (EvoPAR-PR05)","A Randomized, Double-Blind, Placebo-Controlled, 2-Cohort, Phase III Study of Saruparib Combined With Physician's Choice of Androgen Receptor Pathway Inhibitor in Patients With Metastatic Hormone-Sensitive Prostate Cancer, Previously Treated With Docetaxel or PSMA-directed 177Lutetium-Containing Therapy Without Disease Progression, and With Prostate-Specific Antigen ≥ 0.2 ng\u002FmL: EvoPAR-Prostate05","EvoPAR-PR05","Inclusion Criteria:\n\n* Participant must be ≥ 18 at the time of signing the informed consent.\n* Histologically documented diagnosis of prostate adenocarcinoma that is de novo or recurrent and hormone-sensitive.\n* Metastatic disease confirmed prior to initiation of previous treatment with docetaxel or Lu-PSMA-containing regimens for mHSPC.\n* Previous treatment with docetaxel (IV, Q3w)- or Lu-PSMA (IV, Q6w) with last dose within past 6 months.\n* Participants must have the following:\n\n  * Must be receiving ADT with a GnRH analogue or has undergone bilateral orchiectomy.\n  * Had no evidence of disease progression\n  * Had all toxicities related to docetaxel- or Lu-PSMA-containing treatment (except for alopecia and peripheral neuropathy) resolved to CTCAE Grade 1 or lower.\n* PSA ≥ 0.2 ng\u002FmL within 14 days prior to randomization.\n* Serum testosterone \\\u003C 1.7 nmol\u002FL or 50 ng\u002FdL.\n* Palliative radiotherapy for symptoms management will be permitted and is to be completed at least 4 weeks prior to randomization for wide field radiation therapy and at least 2 weeks prior to randomization for limited field radiation therapy.\n* Provision of a FFPE tumor tissue sample and a blood sample (for ctDNA).\n* Confirmed HRRm, HRD and PTEN status.\n* Adequate organ and bone marrow function.\n* Minimum life expectancy of 6 months.\n* Male, assigned at birth, inclusive of all gender identities.\n* Contraceptive use by participants or participant partners should be consistent with local regulations.\n* Capable of giving signed informed consent.\n* \\- -\n\nExclusion Criteria:\n\n* Hypersensitivity to saruparib, ARPI or any excipients of these products or any contraindication or restriction based on the local label.\n* Any history of persisting (\\> 2 weeks) severe cytopenia due to any cause (eg, ANC\\\u003C 0.5 × 10\\^9\u002FL or platelets \\\u003C 50 × 10\\^9\u002FL)\n* Any known predisposition to bleeding (eg, active peptic ulceration, recent \\[within6 months\\] hemorrhagic stroke, proliferative diabetic retinopathy.\n* Spinal cord compression or brain metastases unless asymptomatic and stable.\n* History of MDS\u002FAML or with features suggestive of MDS\u002FAML\n* History of another primary malignancy, with some exceptions.\n* Any chronic gastrointestinal diseases or conditions including inability to swallow the formulated product that would preclude adequate absorption of any study drug.\n* History of seizure or predispose to seizure, including any history of loss of consciousness or transient ischemic attack within 12 months of enrolment.\n* Serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection.\n* Major surgical procedure or significant traumatic injury within 4 weeks of the first dose or an anticipated need for major surgery during the study.\n* Switched ARPI agent in previous treatment for mHSPC due to disease progression. Note: if the ARPI agent was switched due to any reason other than disease progression and switch was prior to ICF signature, participants will be eligible.\n* Any prior treatment with a PARPi or platinum chemotherapy.\n* \\- -","MALE","18 Years",{"count":87,"type":88},1330,"ESTIMATED","INTERVENTIONAL",[91],"PHASE3","The primary objective of this study is to measure efficacy of saruparib + physician's choice of ARPI compared with placebo + ARPI in men with metastatic hormone-sensitive prostate cancer (mHSPC) who have previously received docetaxel chemotherapy or a prostate-specific membrane antigen (PSMA)-directed lutetium-177 radioligand therapy with no evidence of disease progression and PSA ≥ 0.2 ng\u002FmL.",[94],"Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)",[26,96,97,98,99,100,101,102,103,104,105,106,107,108],"HRRm","non-HRRm","mHSPC","Prostate Cancer","AZD5305","PSA>0.2ng\u002Fml","Androgen pathway modulation sensitive (APMS)","Castration sensitive","Metastatic prostate cancer","Hormone sensitive prostate cancer","PARPi","Docetaxel","PSMA-directed 177Lutetium","NOT_YET_RECRUITING","2026-07-14",{"date":112,"type":113},"2026-07-17","ACTUAL",{"date":115,"type":88},"2026-10-01",{"date":117,"type":88},"2033-06-14",{"name":5,"class":6},2]