protocolSection identificationModule nctId: NCT06312670, orgStudyIdInfo id: CASE2823, briefTitle: Combining EPI-7386 With Enzalutamide and Androgen Deprivation Therapy for Metastatic Hormone-Sensitive Prostate Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08-01, primaryCompletionDateStruct date: 2026-03-01, completionDateStruct date: 2026-03-01, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Pedro Barata, MD, MSc, class: OTHER, collaborators name: ESSA Pharma Inc., descriptionModule briefSummary: The purpose of this study is to study the effects of EPI-7386 in combination with Enzalutamide on participants diagnosed with prostate cancer. The main goals of this study are to evaluate the antitumor activity of EPI-7386 in combination with enzalutamide in metastatic hormone-sensitive prostate cancer (mHSPC), and to evaluate the pharmacokinetics (PK) of EPI-7386 when dosed in combination with enzalutamide. Participants will will take the study drug, EPI-7360, twice a day by mouth and enzalutamide once a day by mouth, alongside clinic visits every two weeks., conditionsModule conditions: Metastatic Hormone-sensitive Prostate Cancer (mHSPC), conditions: Prostate Cancer, conditions: Prostate Adenocarcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Phase 2, single-arm study composed of 2 stages: in the first stage, 13 subjects diagnosed with mHSPC will be enrolled and treated with EPI-7386 in combination with enzalutamide. If there are 8 or less subjects with a biochemical response at 6 months, then the trial will be suspended. Otherwise, 22 additional subjects will be enrolled and treated., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 35, type: ESTIMATED, armsInterventionsModule interventions name: EPI-7386, interventions name: Enzalutamide, interventions name: Androgen Deprivation Therapy (ADT), outcomesModule primaryOutcomes measure: Biochemical response rate, primaryOutcomes measure: PSA progesterone-free survival (PFS), primaryOutcomes measure: Radiographic PFS (rPFS), primaryOutcomes measure: ORR (confirmed), secondaryOutcomes measure: AUC0-24, secondaryOutcomes measure: Maximum concentration (Cmax), secondaryOutcomes measure: Predose Plasma Concentration, secondaryOutcomes measure: Time to reach Cmax (Tmax), secondaryOutcomes measure: Terminal elimination half-life, secondaryOutcomes measure: Volume of distribution at steady state after extravascular administration, secondaryOutcomes measure: Clearance after extravascular administration, secondaryOutcomes measure: Treatment-emergent adverse events, secondaryOutcomes measure: Rate of abnormalities in clinical laboratory parameters, secondaryOutcomes measure: Rate of abnormalities in vital sign measurements, secondaryOutcomes measure: Rate of bnormalities in electrocardiograms (ECGs), secondaryOutcomes measure: Changes in Eastern Cooperative Oncology Group (ECOG) performance status, eligibilityModule sex: MALE, minimumAge: 19 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospitals Cleveland Medical Center Seidman Cancer Center, Case Comprehensive Cancer Center, city: Cleveland, state: Ohio, zip: 44106, country: United States, contacts name: Pedro Barata, MD, MSc, role: CONTACT, phone: 216-262-1214, email: Pedro.Barata@UHhospitals.org, geoPoint lat: 41.4995, lon: -81.69541, locations facility: Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center, city: Cleveland, state: Ohio, zip: 44195, country: United States, contacts name: Christopher Wee, MD, role: CONTACT, phone: 866-223-8100, email: TaussigResearch@ccf.org, geoPoint lat: 41.4995, lon: -81.69541, hasResults: False