[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"metastatic-castration-sensitive-prostate-cancer-mcspc\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:metastatic-castration-sensitive-prostate-cancer-mcspc":24},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,37],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":4,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":26,"lastUpdatePostDateStruct":27,"startDateStruct":30,"completionDateStruct":32,"leadSponsor":34,"locationsCount":4},"100652927","a-study-to-learn-about-the-outcomes-between-study-medicines-enzalutamide-and-darolutamide-among-men-with-metastatic-castration-sensitive-prostate-cancer-mcspc-100652927",false,"NCT07779590","A Study to Learn About the Outcomes Between Study Medicines, Enzalutamide and Darolutamide Among Men With Metastatic Castration Sensitive Prostate Cancer (mCSPC)","Real-World Outcomes Among Patients Receiving Enzalutamide Plus ADT or Darolutamide Plus ADT in Metastatic Castration Sensitive Prostate Cancer (mCSPC)","Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:\n\n1. Patients included in the Flatiron Prostate Cancer Panoramic dataset:\n\n   1. Has an International Classification of Diseases (ICD) diagnosis of PC (ICD-9 185x or ICD-10 C61x)\n   2. At least two documented clinic visits on different days in the Flatiron network occurring on or after 01 January 2011\n   3. Has evidence of diagnosis of PC with an initial or metastatic diagnosis date.\n2. Evidence of mCSPC diagnosis date, as defined below:\n\n   a. The mCSPC diagnosis date is determined using information on the date of metastatic diagnosis and the CSPC status. The data of metastatic diagnosis is the earliest date of the first confirmation of metastatic prostate cancer using the following hierarchy, where available: 1) Biopsy specimen collection date from the pathology report; 2) Physician reported date of biopsy; 3) Date of the radiology scan that indicated metastatic disease, if it was later confirmed by the physician; 4) Physician reported date of metastatic diagnosis. CSPC status is determined based on the following hierarchical evidence sources: 1) metastatic diagnosis date (if metastatic at initial diagnosis); 2) Explicit clinician documentation of CSPC; 3) Earliest ADT start date; 4) Clinician documented response or PSA decline while on ADT\n3. Has evidence of treatment with enzalutamide or darolutamide in combination with ADT in the 1L mCSPC setting , on or after 01 August 2022.\n\n   Note: The index date is the start of the ARPI in combination with ADT (i.e., the first episode of ARPI treatment, which can occur up to 90 days after initiation of 1L therapy if ADT is initiated before the ARPI).\n4. Index date is no more than 30 days prior to or 6 months after the mCSPC diagnosis date\n\nPatients meeting any of the following criteria will not be included in the study:\n\n1. Birth sex reported as female or unknown\n2. Age \\\u003C18 years at index date\n3. Evidence of receiving a clinical study drug on or prior to index date\n4. Diagnosed with neuroendocrine and\u002For small cell PC on or prior to index\n5. Diagnosed with additional malignancies, excluding nonmelanoma skin cancer, at any time prior to index date\n6. Index date \\\u003C6 months prior to data cutoff date\n7. Received multiple ARPIs or ARPI in combination with any drug other than ADT or first-generation anti-androgen treatments prior to and up to 28 days after index date\n8. Evidence of ADT or first-generation anti-androgen treatment between 1 year and 91 days prior to index date\n9. Evidence of an orchiectomy occurring more than 90 days prior to index date\n10. Evidence of CRPC any time prior or up to 90 days after the index date\n11. Evidence of treatments for mCRPC on or prior to index date\n12. Has a Line 0 as defined by Flatiron line of therapy (LOT) business rules, indicating potentially missing treatment data at the start of mCSPC setting\n13. Received docetaxel prior to and up to 120 days after index date","MALE","18 Years",{"count":19,"type":20},4700,"ESTIMATED","OBSERVATIONAL","The purpose of this real-world study of electronic medical records is to look back to compare the time to next treatment after initial treatment with enzalutamide or darolutamide in addition to androgen deprivation therapy (ADT). ADT is a hormone therapy used to stop testosterone from being released or to prevent it from acting on prostate cells. The study includes men with metastatic castration-sensitive prostate cancer (mCSPC). This is a cancer that has spread outside the prostate to other parts of the body, but can still be successfully managed by lowering male hormones like testosterone. The study uses data from the Flatiron's Prostate Cancer Panoramic Database. This data base contains information on prostate cancer patients such as their clinical characteristics, lab, vitals, treatments and outcomes.\n\nThis study is seeking participants included in the Flatiron Prostate Cancer Panoramic dataset who:\n\n* Have a diagnosis of prostate cancer (PC) that has spread to other parts of the body\n* With at least two documented clinic visits on different days in the Flatiron network occurring on or after 01 January 2011\n* Has proof of treatment with enzalutamide or darolutamide in combination with ADT as a first line treatment\n* The treatment with enzalutamide or darolutamide in combination with ADT is no more than 30 days prior to or 6 months after the mCSPC diagnosis date\n\nAll participants in this study received at least 1 dose of enzalutamide or darolutamide in combination with ADT. The experiences of the participants receiving the enzalutamide or darolutamide will be looked at.\n\nParticipants will take part in this study for at least 6 months. During this time, they will have at least 2 documented clinic visits from 01 January 2011 to 31 March 2026. These visits will be updated if newer information becomes available at the time of the analysis.",[24],"Metastatic Castration Sensitive Prostate Cancer (mCSPC)","NOT_YET_RECRUITING","2026-08-18",{"date":28,"type":29},"2026-08-21","ACTUAL",{"date":31,"type":20},"2026-09-01",{"date":33,"type":20},"2026-11-15",{"name":35,"class":36},"Pfizer","INDUSTRY",{"id":38,"slug":39,"hasResults":11,"nctId":40,"briefTitle":41,"officialTitle":42,"acronym":4,"eligibilityCriteria":43,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":44,"targetDuration":4,"studyType":46,"phases":47,"briefSummary":49,"conditions":50,"keywords":54,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},"100595161","phase-3-this-study-will-explore-whether-a-combination-of-the-investigational-drug-mevrometostat-pf-06821497-and-enzalutamide-will-work-better-than-taking-enzalutamide-alone-in-participants-with-mcspc-who-are-arpi-nave-100595161","NCT07028853","This Study Will Explore Whether a Combination of the Investigational Drug Mevrometostat (PF-06821497) and Enzalutamide Will Work Better Than Taking Enzalutamide Alone in Participants With mCSPC Who Are ARPI naïve.","A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF MEVROMETOSTAT (PF-06821497) WITH ENZALUTAMIDE IN METASTATIC CASTRATION-SENSITIVE PROSTATE CANCER (MEVPRO-3)","Inclusion Criteria\n\n* Male participants aged ≥18 years (or the minimum age of consent in accordance with local regulations) at screening.\n* Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell features.\n* Metastatic prostate cancer documented by positive bone scan (for bone disease) or metastatic lesion(s) on CT or MRI (for soft tissue\u002Fvisceral disease).\n* Resolution of acute effects of any prior therapy to either baseline severity or CTCAE Grade ≤1 (except for AEs which do not constitute a safety risk in the investigator's judgement).\n* Participants must have ECOG PS 0 or 1.\n\nExclusion Criteria\n\n* Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation\u002Fbehavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.\n* Clinically significant cardiovascular disease.\n* Known or suspected brain metastasis or active leptomeningeal disease.\n* Participants must be treatment naïve at the mCSPC stage, eg, participants cannot have received any cytotoxic chemotherapy with the following exceptions: Treatment with first-generation antiandrogen (ADT) agents is allowed for mCSPC.\n* Previous administration with an investigational product (drug or vaccine) within 30 days.\n* Use of 5-alpha reductase inhibitors is prohibited within 28 days of randomization.\n* Prior surgery from which the participant has not fully recovered at least 28 days prior to randomization\n* Current use or anticipated need for drugs that are known strong CYP3A4\u002F5 inhibitors and inducers (with exception of enzalutamide as part of this study).\n* Inadequate organ function.\n* Known allergic or hypersensitivity reactions to mevrometostat or its excipients or to enzalutamide or its excipients.",{"count":45,"type":20},1000,"INTERVENTIONAL",[48],"PHASE3","This study will explore whether a combination of the investigational drug mevrometostat (PF-06821497) and enzalutamide will work better than taking enzalutamide alone in participants with mCSPC who are ARPI naïve and have not yet received chemotherapy in the mCSPC setting.",[24,51,52,53],"Hormone Sensitive Prostate Cancer","Prostate Cancer","Cancer of the Prostate",[51,55,56,57,58,59,60,61,62,63,64,65,66,67,68,69,70],"Mevrometostat","Metastatic castration sensitive prostate cancer","PF-06821497","EZH2","enhancer of zeste homologue-2","enzalutamide","mCSPC","HSPC","Prostate cancer","castrate sensitive prostate cancer","prostatecancer-study.com","Phase 3","efficacy","safety","pharmacokinetics","pharmacodynamics","RECRUITING","2026-08-13",{"date":74,"type":29},"2026-08-14",{"date":76,"type":29},"2025-09-28",{"date":78,"type":20},"2034-12-08",{"name":35,"class":36},337]