[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07635238":3,"trial-entities:NCT07635238":176,"trial-summary:NCT07635238":180},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":15,"conditions":17,"keywords":20,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":39,"secondary_outcomes":44,"sex":45,"minimum_age":46,"maximum_age":15,"healthy_volunteers":47,"eligibility_criteria":48,"std_ages":90,"locations":93,"central_contacts":163,"overall_officials":169,"references":172,"see_also_links":173},"NCT07635238","26-150","A Study of Lower Dose Radiation Therapy for People With Prostate Cancer","Dose dE-eScalaTion IN prostATe radIOtherapy usiNg an MR-Linac in 2 Fractions - A Randomized Trial (DESTINATION 2)","RECRUITING","2030-05-28","2026-06","2026-06-18","2026-05-28","Memorial Sloan Kettering Cancer Center","OTHER",null,"The purpose of this study is to see whether giving a lower (de-escalated) dose of radiation therapy to some parts of the prostate can reduce side effects compared to giving the same (uniform) dose of radiation therapy to the whole prostate.",[18,19],"Prostate Cancer","Prostate Adenocarcinoma",[18,19,21,13,5],"DESTINATION 2","INTERVENTIONAL","TREATMENT",[25],"PHASE2",{"count":27,"type":28},54,"ESTIMATED",[30],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":37},"RADIATION","MR-guided Stereotactic Body Radiation Therapy","MR-guided 2 fraction Stereotactic Body Radiation Therapy",[35,36],"Group 1: Uniform dose SBRT","Group 2: De-escalated dose SBRT",[38],"MR-guided SBRT",[40],{"measure":41,"description":42,"timeFrame":43},"Number of participants with acute GU toxicities","To estimate the absolute and relative risk of acute GU toxicity (CTCAE v5) when delivering dose de-escalated or uniform dose prostate SBRT, both using a 2-fraction regimen.","12 weeks from the start of radiation therapy",[],"MALE","18 Years",false,{"inclusion":49,"exclusion":88,"raw_text":89},[50,51,52,53,54,55,56,57,58,59,60,61,62,63,64,65,66,67,68,69,70,71,72,73,74,75,76,77,78,79,80,81,82,83,84,85,86,87],"Documentation of Disease","Definition of Disease","Grade Group (GG) 1, 2, or 3.","PSA less than 20 ng\u002FmL prior to starting ADT, if used.","Clinical stage of TX, T1 or T2 on digital rectal examination. May have up to radiological stage T3a on MRI. MRI must be performed within 12 months of randomization.","MRI-visible tumor(s), all having PIRADS v2.1 scores of 3, 4, or 5. Each tumor should be able to be delineated on T2 and diffusion-weighted imaging (DWI) +\u002F- dynamic contrast-enhanced imaging (DCE).","Tumor nodule visible on MRI should be considered able to be boosted by treating clinician (ie meet urethral constraints while maintaining mandatory GTV coverage) and \\\u003C2.5cm in maximal dimension.","The MRI-defined lesion must be confirmed as malignant on biopsies (Grade group 1, 2, or 3).","Patients can be concurrently treated with androgen deprivation therapy (ADT) if this would be standard of care. LHRH analogues, LHRH agonists or Bicalutamide are permitted. ADT is not mandatory where this would usually be omitted. Patients needing greater than 6 months of ADT due to disease parameters should be excluded.","No high grade disease (GG3) occult to MRI-defined lesion. As a guide, any pathology for which you would consider surveillance (e.g. GG1, low volume GG2) is allowed outside of the MRI-defined area.","No contraindications to MRI (e.g. pacemaker, potentially mobile metal implant, claustrophobia).","Prostate volume less than or equal to 90mL.","No evidence of nodal or distant metastatic disease.","Prior Treatment","Age ≥ 18","ECOG Performance Status of ≤ 2 (See Appendix I for performance status criteria)","Required Organ Function","Adequate hematologic function defined as follows:","Absolute neutrophil count (ANC) ≥ 1,500 cells\u002Fmm3","Platelets ≥ 100,000 cells\u002Fmm3","Hemoglobin ≥ 8 g\u002Fdl","Adequate renal function defined as follows:","Creatinine clearance (CrCL) of ≥30 mL\u002Fmin by the Cockcroft-Gault formula:","Adequate hepatic function defined as follows:","Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (patients with known Gilbert's disease who have bilirubin level ≤ 3 x ULN may be enrolled)","AST and ALT ≤3 x institutional ULN","Adequate cardiac function defined as follows:","Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification.","To be eligible for this trial, patients should be class 2B or better (see Appendix II: New York Heart Association (NYHA) Functional Classification).","Comorbid Conditions","No active infection requiring parenteral antibiotic(s).","Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.","No severe GU symptoms that would preclude extreme hypofractionation per the discretion of the treating physician.","No IPSS Score greater than 19.","No comorbidities which predispose to significant toxicity (e.g. inflammatory bowel disease) or preclude long term follow up.","Ability of the participant to understand and the willingness to sign a written informed consent form.","Willing to consent to contraception during and for 1 year after treatment when applicable.","Ability\u002Fwillingness to comply with the patient reported outcome questionnaires schedule throughout the study.",[],"Inclusion Criteria:\n\n* Documentation of Disease\n\n  o Patients must have pathologically confirmed prostate adenocarcinoma.\n* Definition of Disease\n\n  * Grade Group (GG) 1, 2, or 3.\n  * PSA less than 20 ng\u002FmL prior to starting ADT, if used.\n  * Clinical stage of TX, T1 or T2 on digital rectal examination. May have up to radiological stage T3a on MRI. MRI must be performed within 12 months of randomization.\n  * MRI-visible tumor(s), all having PIRADS v2.1 scores of 3, 4, or 5. Each tumor should be able to be delineated on T2 and diffusion-weighted imaging (DWI) +\u002F- dynamic contrast-enhanced imaging (DCE).\n  * Tumor nodule visible on MRI should be considered able to be boosted by treating clinician (ie meet urethral constraints while maintaining mandatory GTV coverage) and \\\u003C2.5cm in maximal dimension.\n  * The MRI-defined lesion must be confirmed as malignant on biopsies (Grade group 1, 2, or 3).\n  * Patients can be concurrently treated with androgen deprivation therapy (ADT) if this would be standard of care. LHRH analogues, LHRH agonists or Bicalutamide are permitted. ADT is not mandatory where this would usually be omitted. Patients needing greater than 6 months of ADT due to disease parameters should be excluded.\n  * No high grade disease (GG3) occult to MRI-defined lesion. As a guide, any pathology for which you would consider surveillance (e.g. GG1, low volume GG2) is allowed outside of the MRI-defined area.\n  * No contraindications to MRI (e.g. pacemaker, potentially mobile metal implant, claustrophobia).\n  * Prostate volume less than or equal to 90mL.\n  * No evidence of nodal or distant metastatic disease.\n* Prior Treatment\n\n  o No history of previous radiation to the prostate, prostate surgery (including transurethral resection of the prostate (TURP)), or other local prostate cancer treatments.\n* Age ≥ 18\n* ECOG Performance Status of ≤ 2 (See Appendix I for performance status criteria)\n* Required Organ Function\n\n  * Adequate hematologic function defined as follows:\n\n    * Absolute neutrophil count (ANC) ≥ 1,500 cells\u002Fmm3\n    * Platelets ≥ 100,000 cells\u002Fmm3\n    * Hemoglobin ≥ 8 g\u002Fdl\n  * Adequate renal function defined as follows:\n\n    * Creatinine clearance (CrCL) of ≥30 mL\u002Fmin by the Cockcroft-Gault formula:\n\nCrCl (mL\u002Fmin) = \\[140 - age (years)\\] x weight (kg) \u002F 72 x creatinine (mg \u002F dL) {x 0.85 for female patients}\n\n* Adequate hepatic function defined as follows:\n\n  * Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (patients with known Gilbert's disease who have bilirubin level ≤ 3 x ULN may be enrolled)\n  * AST and ALT ≤3 x institutional ULN\n* Adequate cardiac function defined as follows:\n\n  * Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification.\n  * To be eligible for this trial, patients should be class 2B or better (see Appendix II: New York Heart Association (NYHA) Functional Classification).\n\n    * Comorbid Conditions\n* No active infection requiring parenteral antibiotic(s).\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n* No severe GU symptoms that would preclude extreme hypofractionation per the discretion of the treating physician.\n* No IPSS Score greater than 19.\n* No comorbidities which predispose to significant toxicity (e.g. inflammatory bowel disease) or preclude long term follow up.\n\n  * Ability of the participant to understand and the willingness to sign a written informed consent form.\n  * Willing to consent to contraception during and for 1 year after treatment when applicable.\n  * Ability\u002Fwillingness to comply with the patient reported outcome questionnaires schedule throughout the study.",[91,92],"ADULT","OLDER_ADULT",[94,109,118,127,137,146,154],{"facility":95,"status":8,"city":96,"state":97,"zip":98,"country":99,"contacts":100,"geoPoint":106},"Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)","Basking Ridge","New Jersey","07920","United States",[101],{"name":102,"role":103,"phone":104,"email":105},"Victoria Brennan, MBBCH BAO","CONTACT","212-639-8904","brennanv@mskcc.org",{"lat":107,"lon":108},40.70621,-74.54932,{"facility":110,"status":8,"city":111,"state":97,"zip":112,"country":99,"contacts":113,"geoPoint":115},"Memorial Sloan Kettering at Monmouth (Limited Protocol Activities)","Middletown","07748",[114],{"name":102,"role":103,"phone":104,"email":105},{"lat":116,"lon":117},40.39428,-74.11709,{"facility":119,"status":8,"city":120,"state":97,"zip":121,"country":99,"contacts":122,"geoPoint":124},"Memorial Sloan Kettering at Bergen (Limited Protocol Activities)","Montvale","07645",[123],{"name":102,"role":103,"phone":104,"email":105},{"lat":125,"lon":126},41.04676,-74.02292,{"facility":128,"status":8,"city":129,"state":130,"zip":131,"country":99,"contacts":132,"geoPoint":134},"Memorial Sloan Kettering at Suffolk-Commack (Limited Protocol Activities)","Commack","New York","11725",[133],{"name":102,"role":103,"phone":104,"email":105},{"lat":135,"lon":136},40.84288,-73.29289,{"facility":138,"status":8,"city":139,"state":130,"zip":140,"country":99,"contacts":141,"geoPoint":143},"Memorial Sloan Kettering at Westchester (Limited Protocol Activities)","Harrison","10604",[142],{"name":102,"role":103,"phone":104,"email":105},{"lat":144,"lon":145},40.96899,-73.71263,{"facility":147,"status":8,"city":130,"state":130,"zip":148,"country":99,"contacts":149,"geoPoint":151},"Memorial Sloan Kettering Cancer Center (All Protocol Activities)","10065",[150],{"name":102,"role":103,"phone":104},{"lat":152,"lon":153},40.71427,-74.00597,{"facility":155,"status":8,"city":156,"state":130,"zip":157,"country":99,"contacts":158,"geoPoint":160},"Memorial Sloan Kettering at Nassau (Limited Protocol Activities)","Uniondale","11553",[159],{"name":102,"role":103,"phone":104,"email":105},{"lat":161,"lon":162},40.70038,-73.59291,[164,165],{"name":102,"role":103,"phone":104,"email":105},{"name":166,"role":103,"phone":167,"email":168},"Zachary Moore, MD, PhD","212-639-5803","MooreZ@mskcc.org",[170],{"name":102,"affiliation":13,"role":171},"PRINCIPAL_INVESTIGATOR",[],[174],{"label":13,"url":175},"http:\u002F\u002Fwww.mskcc.org",{"nct_id":4,"conditions":177,"biomarkers":179},[19,178],"Prostate Carcinoma",[],{"nct_id":4,"found":181,"summary":182,"prompt_version":192},true,{"design":183,"status":184,"heading":185,"summary":186,"follow_up":187,"word_count":188,"commitments":189,"compensation":190,"drugs_mentioned":191},"This is an interventional study that plans to enroll 54 participants. It is testing MR-guided Stereotactic Body Radiation Therapy.","completed","Lower Dose Radiation Therapy for Prostate Cancer","This study is looking at a new way to give radiation therapy for prostate cancer. It's called MR-guided Stereotactic Body Radiation Therapy (SBRT), and it involves giving a lower dose of radiation to some parts of the prostate. The goal is to see if this approach can reduce side effects compared to giving the same dose to the whole prostate. You might be able to join if you are a man, 18 or older, with prostate adenocarcinoma (a type of prostate cancer) that meets specific criteria, including certain Grade Groups and PSA levels. The study will measure how many participants experience acute genitourinary (urinary and genital) side effects 12 weeks after starting radiation therapy. The current status of this study is unclear, and it plans to enroll 54 participants.","The primary endpoint measures side effects at 12 weeks from the start of radiation therapy.",129,"Not specified in the trial record.","Not stated in the trial record.",[32],"v2"]