[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07011342":3,"trial-entities:NCT07011342":150,"trial-summary:NCT07011342":154},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":34,"secondary_outcomes":39,"sex":43,"minimum_age":44,"maximum_age":45,"healthy_volunteers":46,"eligibility_criteria":47,"std_ages":61,"locations":64,"central_contacts":80,"overall_officials":82,"references":86,"see_also_links":149},"NCT07011342","Pro2024-0305","Utility of 18F-rhPSMA-7.3 in the Diagnosis of Prostate Cancer After Focal Gland Treatment","RECRUITING","2028-11","2026-03","2026-03-23","2025-10-01","Hackensack Meridian Health","OTHER",true,"To evaluate the effectiveness of a PSMA-PET scan in identifying recurrent prostate cancer after focal therapy","PSMA is a protein that is highly expressed in prostate cancer cells, making it an excellent specific target for imaging with PET scans that can provide detailed information about the location, extent and aggressiveness of prostate cancer lesions. These scans have proven invaluable for identifying and characterizing prostate cancer, aiding in treatment planning, and Monitoring treatment response. It's true and fully utility in focal therapy for prostate cancer is unknown.",[18],"Prostate Cancer",[20],"PSMA-PET","INTERVENTIONAL","DIAGNOSTIC",[24],"NA",{"count":26,"type":27},70,"ESTIMATED",[29],{"type":30,"name":31,"description":32,"armGroupLabels":33},"DRUG","18F-rhPSMA-7.3","Utility of 18F-rhPSMA-7.3 in the diagnosis of prostate cancer after Focal Gland Treatment (SCOUT)",[31],[35],{"measure":36,"description":37,"timeFrame":38},"To evaluate the effectiveness of PSMA-PET scan in identifying recurrent prostate cancer after focal therapy","All patients will get a biopsy to assess the effectiveness of treatment at 1 year, which is standard protocol at our institutions (all patients undergo biopsy at year 1 and 3 at our institutions). The post-treatment PSMA-PET scan will be correlated to 1-year biopsy results to study the utility of such a scan. Recurrence is defined by a positive PSMA-PET scan and positive biopsy in the area of PET scan tracer uptake at 1 year after SOC focal treatment.","Approximately 1 year after SOC focal therapy.",[40],{"measure":41,"description":42,"timeFrame":38},"To report the sensitivity and specificity in evaluating PSMA-PET scan","Sensitivity and specificity will be reported under the ROC and AUC analysis.","MALE","18 Years",null,false,{"inclusion":48,"exclusion":57,"raw_text":60},[49,50,51,52,53,54,55,56],"Adult males 18 years or older;","Patient must have a pre-treatment MRI;","Patient underwent SOC focal therapy with either focal or hemiablation for the treatment of intermediate risk prostate cancer in the past 9 months prior to enrollment;","Intermediate risk disease as defined by American Urology Academy (AUA)\u002FNational Comprehensive Cancer Network (NCCN) guidelines (see Appendix A)","Life Expectancy of 10 years or more;","Underwent standard template biopsy before treatment with a minimum of 2 cores into the MRI visible lesion if lesion was present;","Patient understands the purpose of the trial and procedures required for the trial, and can provide signed informed consent as which includes compliances with the requirements and restrictions listed in the informed consent form (ICF) and in the study protocol; and","Ability to adhere to the study visit schedule and all the protocol requirements, including surveillance imaging and test specimen (blood sample) collection at specified time points.",[58,59],"Patients under the age of 18 will be considered pediatric patients and will not be included in this study because they are thought to represent a unique population outside the scope of this study as it is aimed at identifying factors that affect adults only.","Patients previously treated with whole gland ablation or prior partial gland ablation over 9 months prior to enrollment.","Inclusion Criteria:\n\n* Adult males 18 years or older;\n* Patient must have a pre-treatment MRI;\n* Patient underwent SOC focal therapy with either focal or hemiablation for the treatment of intermediate risk prostate cancer in the past 9 months prior to enrollment;\n* Intermediate risk disease as defined by American Urology Academy (AUA)\u002FNational Comprehensive Cancer Network (NCCN) guidelines (see Appendix A)\n* Life Expectancy of 10 years or more;\n* Underwent standard template biopsy before treatment with a minimum of 2 cores into the MRI visible lesion if lesion was present;\n* Patient understands the purpose of the trial and procedures required for the trial, and can provide signed informed consent as which includes compliances with the requirements and restrictions listed in the informed consent form (ICF) and in the study protocol; and\n* Ability to adhere to the study visit schedule and all the protocol requirements, including surveillance imaging and test specimen (blood sample) collection at specified time points.\n\nExclusion Criteria:\n\n* Patients under the age of 18 will be considered pediatric patients and will not be included in this study because they are thought to represent a unique population outside the scope of this study as it is aimed at identifying factors that affect adults only.\n* Patients previously treated with whole gland ablation or prior partial gland ablation over 9 months prior to enrollment.",[62,63],"ADULT","OLDER_ADULT",[65],{"facility":66,"status":7,"city":67,"state":68,"zip":69,"country":70,"contacts":71,"geoPoint":77},"John Theurer Cancer Center at Hackensack University Medical Center","Hackensack","New Jersey","07601","United States",[72],{"name":73,"role":74,"phone":75,"email":76},"Oncology Clinical Research Referral Office","CONTACT","551-996-1777","OncologyResearchReferral@hmhn.org",{"lat":78,"lon":79},40.88593,-74.04347,[81],{"name":73,"role":74,"phone":75,"email":76},[83],{"name":84,"affiliation":12,"role":85},"Nitin Yerrman, MD","PRINCIPAL_INVESTIGATOR",[87,91,94,97,100,103,106,109,112,115,118,121,124,127,130,133,136,138,141,144,147],{"pmid":88,"type":89,"citation":90},"33532112","BACKGROUND","Viale PH. The American Cancer Society's Facts & Figures: 2020 Edition. J Adv Pract Oncol. 2020 Mar;11(2):135-136. doi: 10.6004\u002Fjadpro.2020.11.2.1. Epub 2020 Mar 1. No abstract available.",{"pmid":92,"type":89,"citation":93},"34489140","Hopstaken JS, Bomers JGR, Sedelaar MJP, Valerio M, Futterer JJ, Rovers MM. An Updated Systematic Review on Focal Therapy in Localized Prostate Cancer: What Has Changed over the Past 5 Years? Eur Urol. 2022 Jan;81(1):5-33. doi: 10.1016\u002Fj.eururo.2021.08.005. Epub 2021 Sep 4.",{"pmid":95,"type":89,"citation":96},"27825428","Nguyen-Nielsen M, Borre M. Diagnostic and Therapeutic Strategies for Prostate Cancer. Semin Nucl Med. 2016 Nov;46(6):484-490. doi: 10.1053\u002Fj.semnuclmed.2016.07.002. Epub 2016 Sep 3.",{"pmid":98,"type":89,"citation":99},"16985927","Chang SS. Overview of prostate-specific membrane antigen. Rev Urol. 2004;6 Suppl 10(Suppl 10):S13-8.",{"pmid":101,"type":89,"citation":102},"37627956","Cereser L, Evangelista L, Giannarini G, Girometti R. Prostate MRI and PSMA-PET in the Primary Diagnosis of Prostate Cancer. Diagnostics (Basel). 2023 Aug 17;13(16):2697. doi: 10.3390\u002Fdiagnostics13162697.",{"pmid":104,"type":89,"citation":105},"36201182","Kwon DH, Velazquez AI, de Kouchkovsky I. PSMA PET Scan. JAMA Oncol. 2022 Dec 1;8(12):1860. doi: 10.1001\u002Fjamaoncol.2022.3531.",{"pmid":107,"type":89,"citation":108},"31366128","Testa U, Castelli G, Pelosi E. Cellular and Molecular Mechanisms Underlying Prostate Cancer Development: Therapeutic Implications. Medicines (Basel). 2019 Jul 30;6(3):82. doi: 10.3390\u002Fmedicines6030082.",{"pmid":110,"type":89,"citation":111},"36633525","Siegel RL, Miller KD, Wagle NS, Jemal A. Cancer statistics, 2023. CA Cancer J Clin. 2023 Jan;73(1):17-48. doi: 10.3322\u002Fcaac.21763.",{"pmid":113,"type":89,"citation":114},"21056534","Heidenreich A, Bellmunt J, Bolla M, Joniau S, Mason M, Matveev V, Mottet N, Schmid HP, van der Kwast T, Wiegel T, Zattoni F; European Association of Urology. EAU guidelines on prostate cancer. Part 1: screening, diagnosis, and treatment of clinically localised disease. Eur Urol. 2011 Jan;59(1):61-71. doi: 10.1016\u002Fj.eururo.2010.10.039. Epub 2010 Oct 28.",{"pmid":116,"type":89,"citation":117},"21801679","Izawa JI, Klotz L, Siemens DR, Kassouf W, So A, Jordan J, Chetner M, Iansavichene AE. Prostate cancer screening: Canadian guidelines 2011. Can Urol Assoc J. 2011 Aug;5(4):235-40. doi: 10.5489\u002Fcuaj.11134. No abstract available.",{"pmid":119,"type":89,"citation":120},"30442734","Olleik G, Kassouf W, Aprikian A, Hu J, Vanhuyse M, Cury F, Peacock S, Bonnevier E, Palenius E, Dragomir A. Evaluation of New Tests and Interventions for Prostate Cancer Management: A Systematic Review. J Natl Compr Canc Netw. 2018 Nov;16(11):1340-1351. doi: 10.6004\u002Fjnccn.2018.7055.",{"pmid":122,"type":89,"citation":123},"35136289","Atluri S, Mouzannar A, Venkatramani V, Parekh DJ, Nahar B. Focal therapy for localized prostate cancer - Current status. Indian J Urol. 2022 Jan-Mar;38(1):7-14. doi: 10.4103\u002Fiju.iju_166_21. Epub 2022 Jan 1.",{"pmid":125,"type":89,"citation":126},"19050692","Borley N, Feneley MR. Prostate cancer: diagnosis and staging. Asian J Androl. 2009 Jan;11(1):74-80. doi: 10.1038\u002Faja.2008.19. Epub 2008 Dec 1.",{"pmid":128,"type":89,"citation":129},"33052837","Ortner G, Tzanaki E, Rai BP, Nagele U, Tokas T. Transperineal prostate biopsy: The modern gold standard to prostate cancer diagnosis. Turk J Urol. 2021 Feb;47(Supp. 1):S19-S26. doi: 10.5152\u002Ftud.2020.20358. Epub 2020 Oct 9.",{"pmid":131,"type":89,"citation":132},"34911650","Moreira LF, Mussi TC, Cunha MLD, Filippi RZ, Baroni RH. Accuracy of 68Ga-PSMA PET\u002FCT for lymph node and bone primary staging in prostate cancer. Urol Oncol. 2022 Mar;40(3):104.e17-104.e21. doi: 10.1016\u002Fj.urolonc.2021.11.007. Epub 2021 Dec 13.",{"pmid":134,"type":89,"citation":135},"37444512","Hoffman A, Amiel GE. The Impact of PSMA PET\u002FCT on Modern Prostate Cancer Management and Decision Making-The Urological Perspective. Cancers (Basel). 2023 Jun 29;15(13):3402. doi: 10.3390\u002Fcancers15133402.",{"type":89,"citation":137},"Lu, Grace,",{"pmid":139,"type":89,"citation":140},"7063747","Hanley JA, McNeil BJ. The meaning and use of the area under a receiver operating characteristic (ROC) curve. Radiology. 1982 Apr;143(1):29-36. doi: 10.1148\u002Fradiology.143.1.7063747.",{"pmid":142,"type":89,"citation":143},"28094848","Amin MB, Greene FL, Edge SB, Compton CC, Gershenwald JE, Brookland RK, Meyer L, Gress DM, Byrd DR, Winchester DP. The Eighth Edition AJCC Cancer Staging Manual: Continuing to build a bridge from a population-based to a more \"personalized\" approach to cancer staging. CA Cancer J Clin. 2017 Mar;67(2):93-99. doi: 10.3322\u002Fcaac.21388. Epub 2017 Jan 17.",{"pmid":145,"type":89,"citation":146},"35536144","Eastham JA, Auffenberg GB, Barocas DA, Chou R, Crispino T, Davis JW, Eggener S, Horwitz EM, Kane CJ, Kirkby E, Lin DW, McBride SM, Morgans AK, Pierorazio PM, Rodrigues G, Wong WW, Boorjian SA. Clinically Localized Prostate Cancer: AUA\u002FASTRO Guideline, Part I: Introduction, Risk Assessment, Staging, and Risk-Based Management. J Urol. 2022 Jul;208(1):10-18. doi: 10.1097\u002FJU.0000000000002757. Epub 2022 May 10.",{"type":89,"citation":148},"National Comprehensive Cancer Network. Prostate Cancer (Version 4.2024). May 17, 2024]; Available from: https:\u002F\u002Fwww.nccn.org\u002Fprofessionals\u002Fphysician_gls\u002Fpdf\u002Fprostate.pdf.",[],{"nct_id":4,"conditions":151,"biomarkers":153},[152],"Prostate Carcinoma",[],{"nct_id":4,"found":14,"summary":155,"prompt_version":165},{"design":156,"status":157,"heading":158,"summary":159,"follow_up":160,"word_count":161,"commitments":162,"compensation":163,"drugs_mentioned":164},"This is an interventional study with a planned enrollment of 70 participants. It is not specified if it is randomized or blinded.","completed","18F-rhPSMA-7.3 for Prostate Cancer After Focal Treatment","This study is looking at how well a special scan, called a PSMA-PET scan, can find prostate cancer that has come back after a treatment called focal gland therapy. We are testing a substance called 18F-rhPSMA-7.3, which helps the PSMA-PET scan work. PSMA is a protein often found on prostate cancer cells, making it a good target for imaging. This study aims to see if these scans can help doctors understand the location and extent of prostate cancer after focal therapy. You may be able to join if you are an adult male, 18 years or older, who has had an MRI before treatment and underwent focal or hemiablation for intermediate-risk prostate cancer within the last 9 months. The study will measure how effective the PSMA-PET scan is about one year after your focal therapy. The current status of this study is unclear.","Participants will be evaluated approximately 1 year after their standard of care (SOC) focal therapy.",143,"Not specified in the trial record.","Not stated in the trial record.",[31],"v2"]