[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100422969":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":84,"centralContacts":89,"locations":95,"responsibleParty":390,"collaborators":36,"id":392,"slug":393,"hasResults":394,"nctId":395,"briefTitle":396,"officialTitle":397,"acronym":398,"eligibilityCriteria":399,"healthyVolunteers":394,"sex":400,"minAge":401,"maxAge":36,"enrollmentInfo":402,"targetDuration":36,"studyType":405,"phases":406,"briefSummary":409,"conditions":410,"keywords":417,"overallStatus":98,"whyStopped":36,"lastUpdateSubmitDate":428,"lastUpdatePostDateStruct":429,"startDateStruct":432,"completionDateStruct":434,"leadSponsor":436,"locationsCount":437},{"fullName":5,"class":6},"VA Office of Research and Development","FED",[8,22],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard Systemic Therapy (SST)","ACTIVE_COMPARATOR","All Veterans will receive SST (if De novo, Veterans will receive prostate-directed radiation).",[13,14,15,16,17,18,19,20,21],"Drug: Goserelin, Histrelin, Leuprolide & Triptorelin","Drug: ADT + Nilutamide, Flutamide, & Bicalutamide","Drug: Degarelix & Relugolix","Drug: ADT + Docetaxel +\u002F- prednisone","Drug: ADT + Abiraterone + Prednisone","Drug: ADT + Abiraterone + Methylprednisolone","Drug: ADT + Apalutamide","Drug: ADT + Enzalutamide","Radiation: Prostate-directed Radiation for De novo oligometastatic prostate cancer",{"label":23,"type":24,"description":25,"interventionNames":26},"SST + PET-directed local therapy","EXPERIMENTAL","In addition to SST, all Veterans will receive PET-directed local therapy to all metastases using surgery or radiation. If De novo, Veterans will also receive prostate-directed radiation or radical prostatectomy to treat the prostate\u002Fprostate bed. The best course of treatment will be determined using shared decision-making between the physician and Veteran.",[27,28,29,13,14,15,16,17,18,19,20,21],"Procedure: PET-directed Local Therapy using Surgery","Radiation: PET-directed Local Therapy using Radiation","Other: Salvage Local Therapy for locally recurrent disease",[31,37,42,47,52,56,60,64,68,72,76,80],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"PROCEDURE","PET-directed Local Therapy using Surgery","Surgery will be used to treat metastases.",[23],null,{"type":38,"name":39,"description":40,"armGroupLabels":41,"otherNames":36},"RADIATION","PET-directed Local Therapy using Radiation","Radiation therapy will be used to treat metastases.\n\nRadiation options include:\n\n1. Stereotactic body radiotherapy (SBRT) using 1-10 fractions\n2. Conventionally fractionated radiotherapy using elective nodal radiotherapy and a simultaneous integrated boost to involved nodes\n\nThe selection of the form of metastasis-directed radiotherapy for each metastasis will be determined using shared decision-making between the treating physician and the Veteran.",[23],{"type":43,"name":44,"description":45,"armGroupLabels":46,"otherNames":36},"OTHER","Salvage Local Therapy for locally recurrent disease","For Veterans who have a local recurrence in addition to oligorecurrent metastatic lesions, they will undergo salvage local therapy using brachytherapy, SBRT, surgery, cryotherapy or HIFU. The selection of modality of salvage local therapy will be determined using shared decision-making between the treating physician and Veteran.",[23],{"type":48,"name":49,"description":50,"armGroupLabels":51,"otherNames":36},"DRUG","Goserelin, Histrelin, Leuprolide & Triptorelin","Androgen deprivation therapy (ADT) using an LHRH agonist",[23,9],{"type":48,"name":53,"description":54,"armGroupLabels":55,"otherNames":36},"ADT + Nilutamide, Flutamide, & Bicalutamide","ADT adding anti-androgen therapy to an LHRH agonist",[23,9],{"type":48,"name":57,"description":58,"armGroupLabels":59,"otherNames":36},"Degarelix & Relugolix","ADT using an LHRH Antagonist.",[23,9],{"type":48,"name":61,"description":62,"armGroupLabels":63,"otherNames":36},"ADT + Docetaxel +\u002F- prednisone","Enhanced SST using chemohormonal therapy",[23,9],{"type":48,"name":65,"description":66,"armGroupLabels":67,"otherNames":36},"ADT + Abiraterone + Prednisone","Enhanced SST using Abiraterone + Prednisone",[23,9],{"type":48,"name":69,"description":70,"armGroupLabels":71,"otherNames":36},"ADT + Abiraterone + Methylprednisolone","Enhanced SST using Abiraterone + Methylprednisolone",[23,9],{"type":48,"name":73,"description":74,"armGroupLabels":75,"otherNames":36},"ADT + Apalutamide","Enhanced SST using ADT + Apalutamide",[23,9],{"type":48,"name":77,"description":78,"armGroupLabels":79,"otherNames":36},"ADT + Enzalutamide","Enhanced SST using ADT + Enzalutamide",[23,9],{"type":38,"name":81,"description":82,"armGroupLabels":83,"otherNames":36},"Prostate-directed Radiation for De novo oligometastatic prostate cancer","Veterans in ARM 1 will receive prostate-directed RT only and NO treatment to any nodal or distant metastatic sites.\n\nAcceptable dose\u002Ffractionations include 55 Gy in 20 fractions and 36 Gy in 6 fractions.\n\nVeterans in ARM 2 should receive prostate-directed local therapy using radiotherapy or radical prostatectomy in addition to PET-directed local therapy to metastases.",[23,9],[85],{"name":86,"affiliation":87,"role":88},"Abhishek Solanki, MD MS","Edward Hines Jr. VA Hospital, Hines, IL","PRINCIPAL_INVESTIGATOR",[90],{"name":86,"role":91,"phone":92,"phoneExt":93,"email":94},"CONTACT","(708) 202-8387","27091","Abhishek.Solanki@va.gov",[96,115,130,149,165,178,193,207,222,237,248,259,269,278,293,308,323,338,354,375],{"facility":97,"status":98,"city":99,"state":100,"zip":101,"country":102,"countryCode":103,"cosmosGeoPoint":104,"geoPoint":109,"contacts":110},"VA Long Beach Healthcare System, Long Beach, CA","RECRUITING","Long Beach","California","90822","United States","US",{"type":105,"coordinates":106},"Point",[107,108],-118.18923,33.76696,{"lat":108,"lon":107},[111],{"name":112,"role":91,"phone":113,"phoneExt":36,"email":114},"Robert Kwon, MD","562-826-5606","Robert.Kwon1@va.gov",{"facility":116,"status":98,"city":117,"state":100,"zip":118,"country":102,"countryCode":103,"cosmosGeoPoint":119,"geoPoint":123,"contacts":124},"VA Greater Los Angeles Healthcare System, West Los Angeles, CA","West Los Angeles","90073",{"type":105,"coordinates":120},[121,122],-118.43068,34.0462,{"lat":122,"lon":121},[125],{"name":126,"role":91,"phone":127,"phoneExt":128,"email":129},"Nicholas Nickols, MD","310-478-3711","44127","nicholas.nickols@va.gov",{"facility":131,"status":98,"city":132,"state":133,"zip":134,"country":102,"countryCode":103,"cosmosGeoPoint":135,"geoPoint":139,"contacts":140},"Washington DC VA Medical Center, Washington, DC","Washington D.C.","District of Columbia","20422-0001",{"type":105,"coordinates":136},[137,138],-77.03637,38.89511,{"lat":138,"lon":137},[141,145],{"name":142,"role":91,"phone":143,"phoneExt":36,"email":144},"Ruchika Gutt, MD","301-.92-0873","ruchika.gutt@va.gov",{"name":146,"role":91,"phone":147,"phoneExt":36,"email":148},"Robert Curran, BA","202.745.2277","robert.curran@va.gov",{"facility":150,"status":98,"city":151,"state":152,"zip":153,"country":102,"countryCode":103,"cosmosGeoPoint":154,"geoPoint":158,"contacts":159},"Bay Pines VA Healthcare System, Pay Pines, FL","Bay Pines","Florida","33744",{"type":105,"coordinates":155},[156,157],-82.77816,27.81419,{"lat":157,"lon":156},[160],{"name":161,"role":91,"phone":162,"phoneExt":163,"email":164},"Ryan Burri, MD","727-398-6661","13912","ryan.burri@va.gov",{"facility":87,"status":98,"city":166,"state":167,"zip":168,"country":102,"countryCode":103,"cosmosGeoPoint":169,"geoPoint":173,"contacts":174},"Hines","Illinois","60141-3030",{"type":105,"coordinates":170},[171,172],-87.8395,41.85364,{"lat":172,"lon":171},[175,177],{"name":86,"role":91,"phone":176,"phoneExt":93,"email":94},"708-202-8387",{"name":86,"role":88,"phone":36,"phoneExt":36,"email":36},{"facility":179,"status":98,"city":180,"state":181,"zip":182,"country":102,"countryCode":103,"cosmosGeoPoint":183,"geoPoint":187,"contacts":188},"Richard L. Roudebush VA Medical Center, Indianapolis, IN","Indianapolis","Indiana","46202-2884",{"type":105,"coordinates":184},[185,186],-86.15804,39.76838,{"lat":186,"lon":185},[189],{"name":190,"role":91,"phone":191,"phoneExt":36,"email":192},"Ronald Shapiro, MD","317-988-3652","ronald.shapiro@va.gov",{"facility":194,"status":98,"city":195,"state":196,"zip":197,"country":102,"countryCode":103,"cosmosGeoPoint":198,"geoPoint":202,"contacts":203},"Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD","Baltimore","Maryland","21201",{"type":105,"coordinates":199},[200,201],-76.61219,39.29038,{"lat":201,"lon":200},[204],{"name":205,"role":91,"phone":36,"phoneExt":36,"email":206},"Christine Bang, MD","Christine.Bang@va.gov",{"facility":208,"status":98,"city":209,"state":210,"zip":211,"country":102,"countryCode":103,"cosmosGeoPoint":212,"geoPoint":216,"contacts":217},"VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA","Boston","Massachusetts","02130",{"type":105,"coordinates":213},[214,215],-71.05977,42.35843,{"lat":215,"lon":214},[218],{"name":219,"role":91,"phone":220,"phoneExt":36,"email":221},"Sonny Batra, MD","857-404-1215","Sonny.Batra@va.gov",{"facility":223,"status":98,"city":224,"state":225,"zip":226,"country":102,"countryCode":103,"cosmosGeoPoint":227,"geoPoint":231,"contacts":232},"VA Ann Arbor Healthcare System, Ann Arbor, MI","Ann Arbor","Michigan","48105",{"type":105,"coordinates":228},[229,230],-83.74088,42.27756,{"lat":230,"lon":229},[233],{"name":234,"role":91,"phone":235,"phoneExt":36,"email":236},"David Elliot, MD","734-845-3914","david.elliott1@va.gov",{"facility":238,"status":239,"city":240,"state":241,"zip":242,"country":102,"countryCode":103,"cosmosGeoPoint":243,"geoPoint":247,"contacts":36},"Minneapolis VA Health Care System, Minneapolis, MN","ACTIVE_NOT_RECRUITING","Minneapolis","Minnesota","55417-2309",{"type":105,"coordinates":244},[245,246],-93.26384,44.97997,{"lat":246,"lon":245},{"facility":249,"status":250,"city":251,"state":252,"zip":253,"country":102,"countryCode":103,"cosmosGeoPoint":254,"geoPoint":258,"contacts":36},"Kansas City VA Medical Center, Kansas City, MO","TERMINATED","Kansas City","Missouri","64128-2226",{"type":105,"coordinates":255},[256,257],-94.57857,39.09973,{"lat":257,"lon":256},{"facility":260,"status":250,"city":261,"state":262,"zip":263,"country":102,"countryCode":103,"cosmosGeoPoint":264,"geoPoint":268,"contacts":36},"East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ","East Orange","New Jersey","07018",{"type":105,"coordinates":265},[266,267],-74.20487,40.76732,{"lat":267,"lon":266},{"facility":270,"status":250,"city":271,"state":271,"zip":272,"country":102,"countryCode":103,"cosmosGeoPoint":273,"geoPoint":277,"contacts":36},"VA NY Harbor Healthcare System, New York, NY","New York","10010-5011",{"type":105,"coordinates":274},[275,276],-74.00597,40.71427,{"lat":276,"lon":275},{"facility":279,"status":98,"city":280,"state":281,"zip":282,"country":102,"countryCode":103,"cosmosGeoPoint":283,"geoPoint":287,"contacts":288},"Durham VA Medical Center, Durham, NC","Durham","North Carolina","27705",{"type":105,"coordinates":284},[285,286],-78.89862,35.99403,{"lat":286,"lon":285},[289],{"name":290,"role":91,"phone":291,"phoneExt":36,"email":292},"Rhonda Bitting, MD","415-516-8256","rhonda.bitting@va.gov",{"facility":294,"status":98,"city":295,"state":296,"zip":297,"country":102,"countryCode":103,"cosmosGeoPoint":298,"geoPoint":302,"contacts":303},"Louis Stokes VA Medical Center, Cleveland, OH","Cleveland","Ohio","44106",{"type":105,"coordinates":299},[300,301],-81.69541,41.4995,{"lat":301,"lon":300},[304],{"name":305,"role":91,"phone":306,"phoneExt":36,"email":307},"Aryavarta Kumar, MD","216-536-1201","aryavarta.kumar@va.gov",{"facility":309,"status":98,"city":310,"state":311,"zip":312,"country":102,"countryCode":103,"cosmosGeoPoint":313,"geoPoint":317,"contacts":318},"Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA","Philadelphia","Pennsylvania","19104-4551",{"type":105,"coordinates":314},[315,316],-75.16362,39.95238,{"lat":316,"lon":315},[319],{"name":320,"role":91,"phone":321,"phoneExt":36,"email":322},"Yu-Ning Wong, MD","215-823-5900","Yu-Ning.Wong@va.gov",{"facility":324,"status":98,"city":325,"state":326,"zip":327,"country":102,"countryCode":103,"cosmosGeoPoint":328,"geoPoint":332,"contacts":333},"Michael E. DeBakey VA Medical Center, Houston, TX","Houston","Texas","77030",{"type":105,"coordinates":329},[330,331],-95.36327,29.76328,{"lat":331,"lon":330},[334],{"name":335,"role":91,"phone":336,"phoneExt":36,"email":337},"Albert Chen, MD","713-794-7190","albert.chen3@va.gov",{"facility":339,"status":98,"city":340,"state":341,"zip":342,"country":102,"countryCode":103,"cosmosGeoPoint":343,"geoPoint":347,"contacts":348},"Hunter Holmes McGuire VA Medical Center, Richmond, VA","Richmond","Virginia","23249",{"type":105,"coordinates":344},[345,346],-77.46026,37.55376,{"lat":346,"lon":345},[349],{"name":350,"role":91,"phone":351,"phoneExt":352,"email":353},"Hann-Hsiang Chao, MD","804-675-5000","3750","hann-hsiang.chao@va.gov",{"facility":355,"status":98,"city":356,"state":357,"zip":358,"country":102,"countryCode":103,"cosmosGeoPoint":359,"geoPoint":363,"contacts":364},"William S. Middleton Memorial Veterans Hospital, Madison, WI","Madison","Wisconsin","53705-2254",{"type":105,"coordinates":360},[361,362],-89.40123,43.07305,{"lat":362,"lon":361},[365,370],{"name":366,"role":91,"phone":367,"phoneExt":368,"email":369},"Jessica Schuster, MD","608-256-1901","11097","Jessica.Schuster@va.gov",{"name":371,"role":91,"phone":372,"phoneExt":373,"email":374},"Leigh Fisher","6082561901","10313","Leigh.Fisher@va.gov",{"facility":376,"status":98,"city":377,"state":357,"zip":378,"country":102,"countryCode":103,"cosmosGeoPoint":379,"geoPoint":383,"contacts":384},"Clement J. Zablocki VA Medical Center, Milwaukee, WI","Milwaukee","53295-1000",{"type":105,"coordinates":380},[381,382],-87.90647,43.0389,{"lat":382,"lon":381},[385],{"name":386,"role":91,"phone":387,"phoneExt":388,"email":389},"Lindsay Puckett, MD","414-384-2000","42590","Lindsay.Puckett@va.gov",{"type":391,"investigatorFullName":36,"investigatorTitle":36,"investigatorAffiliation":36,"oldNameTitle":36,"oldOrganization":36},"SPONSOR","100422969","phase-2-veterans-affairs-seamless-phase-iiiii-randomized-trial-of-standard-systemic-therapy-with-or-without-pet-directed-local-therapy-for-oligometastatic-prostate-cancer-100422969",false,"NCT04787744","Veterans Affairs Seamless Phase II\u002FIII Randomized Trial of STAndard Systemic theRapy With or Without PET-directed Local Therapy for Oligometastatic pRosTate Cancer","Veterans Affairs Seamless Phase II\u002FIII Randomized Trial of STAndard Systemic theRapy With or Without PET-directed Local Therapy for OligoRecurrenT Prostate Cancer (VA STARPORT)","VA STARPORT","Inclusion Criteria:\n\nAge 18 years. Ability to provide Informed Consent for participation in the study ECOG Performance Status 2 at time of enrollment. Prostate cancer, confirmed histologically or cytologically. If original documentation of histology and cytology are not available, documentation of prostate cancer satisfies these criteria. If recurrent, prior curative-intent local therapy to all sites of prostate cancer with either upfront radiotherapy or prostatectomy with or without post-operative radiotherapy.\n\nIf recurrent, PSA suspicious for biochemical recurrence after local therapy, with lab value(s) taken prior to start of SST (if current SST has already started) or within 90 days prior to enrollment if not already on SST, and meeting one of the three below categories:\n\nPSA 0.2 ng\u002Fml x 2 after prostatectomy +\u002F- post-operative radiotherapy; Elevation of PSA 2 ng\u002Fml above the nadir after definitive radiotherapy; Or Two consecutively elevated PSAs with evidence of metastasis on the imaging Studies.\n\n-Serum testosterone obtained prior to randomization based on one of the criteria below:\n\nFor patients who have a history of a prior episode of therapy with SST agents for prostate cancer, a total testosterone 100 ng\u002Fdl after completion of the prior episode of SST and before the start of current SST or within 30 days of starting current SST if the patient has already started SST for recurrence.\n\nFor patients who have no prior history of an episode of therapy with SST agents and have already started SST for recurrence, this pre-SST testosterone is not required.\n\nCT or MRI abdomen\u002Fpelvis performed prior to start of SST (if current SST has already started) or within 90 days prior to enrollment if not already on SST. The results from the CT component of the PET\u002FCT can be used to fulfill this criterion. This is optional for patients who have a PSMA PET\u002FCT. Yechnetium (Tc99m-MDP) or sodium fluoride (NaF) bone scan (sodium fluoride preferred) performed prior to start of SST (if current SST has already started), or within 90 days prior to enrollment if not already on SST. This is optional for patients who have a PSMA PET\u002FCT. Prostate PET\u002FCT (currently PSMA, Fluciclovine, choline) performed prior to start of SST (if current SST has already started), or within 90 days prior to enrollment if not already on SST.\n\n1-10 lesions suspicious for nodal recurrence or metastasis from prostate cancer as determined by the investigator based on the above imaging studies.\n\nHas already undergone NPOP sequencing or a plan is in place for NPOP sequencing for prostate cancer.\n\nFor participants on SST at the time of enrollment only:\n\nHas been on SST for 180 days. For participants with local recurrence after curative-intent local therapy on imaging :\n\nPatients with local recurrence in the prostate, SV, or prostate bed are eligible as long as there is at least 1 nodal or distant metastatic recurrence. Biopsy must confirm local recurrence for patients who have had prior curative-intent radiation to the prostate, SV, or prostate bed.\n\nCandidate for salvage local therapy (refer to Section 10.4) as determined by a urologist or radiation oncologist (depending on the respective modality to be used to treat the local recurrence).\n\nFor participants with de novo prostate cancer:\n\nCandidate for prostate-directed radiation.\n\nExclusion Criteria:\n\n* Any current or prior evidence of castration-resistant prostate cancer, defined as two consecutive rises in serum PSA, obtained at a minimum of 1-week interval, with the final PSA value \\>\u002F= 1 ng\u002Fml, while having a total testosterone \\\u003C 50 ng\u002Fdl).\n* Prior malignancy, except the following:\n\n  * Adequately treated non-melanomatous skin cancer;\n  * Adequately treated Stage 0, I, or II cancer from which the patient is currently in complete remission; or\n  * Any other cancer from which the patient has been disease free for three years.\n* Presence of a symptomatic metastasis that requires palliative radiotherapy.\n* Any known brain metastases, presence of leptomeningeal disease, malignant spinal cord compression, or malignant cauda equina syndrome.\n* Prior nodal, bone, or visceral metastasis after curative-intent therapy other than those identified on the enrollment imaging studies which make the patient ineligible for PET-directed local therapy (per investigator discretion).\n* Prior radiation therapy to any sites requiring PET-directed local therapy or salvage local therapy that will lead to prohibitively high risk of toxicity from subsequent local therapy, as determined by the treating radiation oncologist (if radiation is intended as the study local therapy) or surgeon\u002Furologist (if surgery is intended as the study local therapy).\n* Any other previous or current condition, which, in the judgement of the LSI, is likely to interfere with any STARPORT treatments or assessments.","MALE","18 Years",{"count":403,"type":404},464,"ESTIMATED","INTERVENTIONAL",[407,408],"PHASE2","PHASE3","This is a prospective, open-label, multi-center seamless phase II to phase III randomized clinical trial designed to compare SST with or without PET-directed local therapy in improving the castration-resistant prostate cancer-free survival (CRPC-free survival) for Veterans with oligometastatic prostate cancer. Oligometastasis will be defined as 1-10 sites of metastatic disease based on the clinical determination of the LSI which incorporates all imaging, clinical, and pathologic data available.",[411,412,413,414,415,416],"Prostate Cancer","Oligometastasis","Oligorecurrence","Recurrent Prostate Cancer","Metastatic Prostate Cancer","De Novo Prostate Cancer",[411,418,413,419,420,421,412,422,423,424,414,425,426,427],"Metastasis","PET-directed local therapy","Standard Systemic Therapy","SBRT","Oligorecurrent","Metastasis-directed therapy","Salvage Local Therapy","Fluciclovine","PSMA","Choline","2026-04-02",{"date":430,"type":431},"2026-04-08","ACTUAL",{"date":433,"type":431},"2021-07-01",{"date":435,"type":404},"2029-03-30",{"name":5,"class":6},20]