[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100623225":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":22,"centralContacts":22,"locations":33,"responsibleParty":80,"collaborators":84,"id":90,"slug":91,"hasResults":92,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":96,"eligibilityCriteria":97,"healthyVolunteers":92,"sex":98,"minAge":99,"maxAge":22,"enrollmentInfo":100,"targetDuration":22,"studyType":103,"phases":104,"briefSummary":106,"conditions":107,"keywords":111,"overallStatus":54,"whyStopped":22,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":131},{"fullName":5,"class":6},"Brigham and Women's Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"ADT + SBRT + PSMA PET\u002FCT Imaging","EXPERIMENTAL","* ADT as prescribed\n* PSMA PET\u002FCT imaging will be completed at baseline, 8 weeks after ADT start, and at end of treatment\n* SBRT is administered starting 10 weeks after ADT start",[13,14,15],"Diagnostic Test: PSMA PET\u002FCT","Drug: Androgen Deprivation Therapy (ADT) +\u002F- bicalutamide","Radiation: Stereotactic Body Radiation Therapy (SBRT) +\u002F- focal microboost",[17,23,28],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":22},"DIAGNOSTIC_TEST","PSMA PET\u002FCT","PSMA PET\u002FCT is an imaging test that uses a radioactive tracer to highlight prostate cancer cells. Imaging will be performed at baseline, approximately eight weeks after starting ADT, and approximately 24 weeks after starting ADT (end of treatment). These scans are used to guide radiation treatment planning and assess treatment response.",[9],null,{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":22},"DRUG","Androgen Deprivation Therapy (ADT) +\u002F- bicalutamide","ADT is used to lower testosterone levels, which can slow or shrink prostate tumors. All participants will receive approximately six months of ADT starting before radiation therapy, using injectable or oral medications. Depending on the type of ADT, participants may also receive daily bicalutamide. Bicalutamide is categorized as an antiandrogen, which means it will block the effects of testosterone and work together with ADT to slow down or shrink prostate cancer.",[9],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":22},"RADIATION","Stereotactic Body Radiation Therapy (SBRT) +\u002F- focal microboost","SBRT is a form of radiation therapy that delivers precise, high-dose radiation to the prostate over a short period of time. SBRT will be initiated 10 weeks after initiation of ADT and will be delivered in five sessions over two weeks. Based on PSMA PET\u002FCT and MRI findings after initiation of ADT, some participants may receive an optional focal radiation microboost to areas of residual cancer. The microboost, if delivered, will be given during the same SBRT treatment sessions and will be limited by standard safety constraints.",[9],[34,47,52,68],{"facility":5,"status":35,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":22},"NOT_YET_RECRUITING","Boston","Massachusetts","02115","United States","US",{"type":42,"coordinates":43},"Point",[44,45],-71.05977,42.35843,{"lat":45,"lon":44},{"facility":48,"status":35,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":49,"geoPoint":51,"contacts":22},"Dana Farber Cancer Institute",{"type":42,"coordinates":50},[44,45],{"lat":45,"lon":44},{"facility":53,"status":54,"city":55,"state":37,"zip":56,"country":39,"countryCode":40,"cosmosGeoPoint":57,"geoPoint":61,"contacts":62},"Dana-Farber\u002FBrigham and Women's Cancer Center at Milford Regional Medical Center","RECRUITING","Milford","01757",{"type":42,"coordinates":58},[59,60],-71.51617,42.13982,{"lat":60,"lon":59},[63],{"name":64,"role":65,"phone":66,"phoneExt":22,"email":67},"Luke Peng, MD","CONTACT","508-488-3800","lcpeng@bwh.harvard.edu",{"facility":69,"status":54,"city":70,"state":37,"zip":71,"country":39,"countryCode":40,"cosmosGeoPoint":72,"geoPoint":76,"contacts":77},"Dana-Farber\u002FBrigham and Women's Cancer Center in Clinical Affiliation with South Shore Hospital","Weymouth","02190",{"type":42,"coordinates":73},[74,75],-70.93977,42.22093,{"lat":75,"lon":74},[78],{"name":79,"role":65,"phone":66,"phoneExt":22,"email":67},"Luke Peng",{"type":81,"investigatorFullName":82,"investigatorTitle":83,"investigatorAffiliation":5,"oldNameTitle":22,"oldOrganization":22},"SPONSOR_INVESTIGATOR","Martin T. King, MD, PhD","Director, Brachytherapy Clinical Operations, Associate Professor of Radiation Oncology, Harvard Medical School",[85,88],{"name":86,"class":87},"Blue Earth Diagnostics","INDUSTRY",{"name":89,"class":6},"Dana-Farber\u002FBrigham and Women's Cancer Center","100623225","phase-2-androgen-responsive-posluma-guided-intra-prostatic-boost-100623225",false,"NCT07393867","Androgen-responsive POSLUMA-guided Intra-prostatic Boost","Androgen-responsive POSLUMA-guided Intra-prostatic Boost (ARPEGGIO)","ARPEGGIO","Inclusion Criteria:\n\n* 18 years of age and older.\n* Eastern Oncology Group Status 0 to 1.\n* Histologic diagnosis of prostate cancer.\n* Prior screening MRI with at least one PI-RADS4 or PI-RADS 5 lesion, obtained within 180 days of screening.\n* NCCN intermediate-risk or high-risk prostate cancer (Appendix B). All patients will be staged by MRI.\n* Prior PSMA PET scan with at least one focal avid lesion greater than background prostate that is concordant with a lesion on MRI, obtained within 180 days of screening.\n* Intention for SBRT (36.25 Gy\u002F5 fraction) with focal boost (up to 50 Gy) to one MRI\u002FPET-concordant lesion34.\n\nExclusion Criteria:\n\n* Prior imaging (CT, bone scan, MRI, PSMA-PET\u002FCT) showing nodal or distant disease.\n* Intention to receive treatment intensification with secondary androgen receptor signaling inhibitors or chemotherapy.\n* Clinical T4 disease.\n* Prior ADT.\n* Prior pelvic RT.\n* Prior prostate surgery, including TURP.\n* International prostate symptom score \\> 20.\n* Prior urethral stricture.\n* Prostate volume \\> 80 cc on MRI.\n* Hip implants that cause artifacts over the prostate gland.\n* Inability to discontinue anti-coagulation for fiducial marker placement.\n* Active Crohn's disease or scleroderma.","MALE","18 Years",{"count":101,"type":102},23,"ESTIMATED","INTERVENTIONAL",[105],"PHASE2","This research study is for men with intermediate- or high-risk prostate cancer who are planning to receive hormone therapy and radiation treatment. The purpose of the study is to see whether a special type of diagnostic imaging done during hormone therapy can help doctors more accurately target remaining cancer with radiation, while avoiding areas that may no longer need extra treatment. All participants will receive standard hormone therapy and radiation therapy, along with three imaging scans, over a six-month period. The information gained from this study may help make prostate cancer radiation treatment more precise and reduce side effects for future patients.",[108,109,110],"Intermediate Risk Prostate Cancer","High Risk Prostate Cancer","Prostate Cancer",[112,113,114,115,116,117,118,119,120,121],"POSLUMA","prostate-specific membrane antigen positron-emission tomography","PSMA-PET\u002FCT","18F-flotufolastat-PSMA-PET\u002FCT scan","ADT and 18F-flotufolastat-guided focal SBRT microboost","androgen deprivation therapy and 18F-flotufolastat-guided focal SBRT microboost","neoadjuvant ADT","neoadjuvant androgen deprivation therapy","neoadjuvant ADT prior to SBRT","18F-flotufolastat-PET\u002FCT scans for intermediate and high risk prostate cancer","2026-05-27",{"date":124,"type":125},"2026-05-29","ACTUAL",{"date":127,"type":125},"2026-04-29",{"date":129,"type":102},"2027-12-15",{"name":82,"class":6},4]