[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100623080":3},{"organization":4,"outcomesModule":7,"designInfo":49,"detailedDescription":48,"studyPopulation":48,"armGroups":55,"interventions":64,"overallOfficials":48,"centralContacts":74,"locations":80,"responsibleParty":97,"collaborators":99,"id":106,"slug":48,"hasResults":107,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":107,"sex":113,"minAge":114,"maxAge":48,"enrollmentInfo":115,"targetDuration":48,"studyType":118,"phases":119,"briefSummary":121,"conditions":122,"keywords":124,"overallStatus":82,"whyStopped":48,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":137},{"fullName":5,"class":6},"The Netherlands Cancer Institute","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":48},[9],{"measure":10,"description":11,"timeFrame":12},"Acute GU toxicity","Physician-reported acute Grade 2 or higher CTCAE GU toxicity observed within 13 weeks of starting radiotherapy","within 13 weeks of starting radiotherapy",[14,18,22,26,30,34,37,40,44],{"measure":15,"description":16,"timeFrame":17},"Dosimetry","Estimate the accumulated dose differences between treatment arms in terms of dose to prostate CTV, rectum, urethra and bladder","During Radiotherapy treatment of 8 days",{"measure":19,"description":20,"timeFrame":21},"Late GI toxicity","Physician reported late GI toxicity according to CTCAE v5.0","1 and 2 years after radiotherapy treatment",{"measure":23,"description":24,"timeFrame":25},"Biochemical relapse-free survival","Assess biochemical relapse-free survival for 2 years","2 years",{"measure":27,"description":28,"timeFrame":29},"Severity of erectile dysfunction experienced by patient","The IIEF-5 patient reported outcomes (PROs) assess the acute severity of erectile dysfunction","Before radiotherapy treatment, and at 6, 12 and 24 months after radiotherapy treatment",{"measure":31,"description":32,"timeFrame":33},"Acute GI toxicity","Physician reported acute GI toxicity according to CTCAE v5.0","At baseline, after the last fraction, and 2, 4 and 12 weeks after radiotherapy treatment",{"measure":35,"description":36,"timeFrame":21},"Late GU toxicity","Physician reported late GU toxicity according to CTCAE v5.0",{"measure":38,"description":39,"timeFrame":21},"Late sexual toxicity","Physician reported late sexual toxicity according to CTCAE v5.0",{"measure":41,"description":42,"timeFrame":43},"Severity of urinary symptoms (GU) experienced by patient","The patient reported outcomes (PROs) International Prostate Symptoms Score (IPSS) assess the severity of urinary symptoms what the patient experiences","Before radiotherapy treatment, after the last fraction, at 2, 4 and 12 weeks post-treatment, and at 6, 12 and 24 months after radiotherapy treatment",{"measure":45,"description":46,"timeFrame":47},"Health-related quality of life experienced by patient","The EPIC-26 patient reported outcomes (PROs) assess the health-related quality of life","Before start radiotherapy, week 4 and week 12, at 6, 12 and 24 months after radiotherapy treatment.",null,{"allocation":50,"interventionModel":51,"interventionModelDescription":48,"primaryPurpose":52,"observationalModel":48,"timePerspective":48,"maskingInfo":53},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":54,"maskingDescription":48,"whoMasked":48},"NONE",[56,60],{"label":57,"type":6,"description":48,"interventionNames":58},"Uniform dose SBRT",[59],"Radiation: uniform dose radiotherapy",{"label":61,"type":6,"description":48,"interventionNames":62},"De-escalated dose SBRT",[63],"Radiation: De-escalated dose radiotherapy",[65,70],{"type":66,"name":67,"description":68,"armGroupLabels":69,"otherNames":48},"RADIATION","uniform dose radiotherapy","27 Gy dose in 2 fractions to the whole prostate+\u002F- seminal vesicles with a 0mm PTV margin using MR-linac",[57],{"type":66,"name":71,"description":72,"armGroupLabels":73,"otherNames":48},"De-escalated dose radiotherapy","The benign prostate +\u002F- SV CTV will receive 20 Gy in 2 fractions with a 0mm PTV margin using MR-linac. The intraprostatic tumor masses (on MRI) will receive 27 Gy in 2 fractions. A 4mm GTV to PTV margin will be added to the in-traprostatic MR visible tumour to form PTV 27Gy.",[61],[75],{"name":76,"role":77,"phone":78,"phoneExt":48,"email":79},"Floris Pos, MD, PhD","CONTACT","+31205129111","f.pos@nki.nl",[81],{"facility":5,"status":82,"city":83,"state":48,"zip":84,"country":85,"countryCode":86,"cosmosGeoPoint":87,"geoPoint":92,"contacts":93},"RECRUITING","Amsterdam","1066CX","Netherlands","NL",{"type":88,"coordinates":89},"Point",[90,91],4.88969,52.37403,{"lat":91,"lon":90},[94,95],{"name":76,"role":77,"phone":78,"phoneExt":48,"email":79},{"name":48,"role":77,"phone":48,"phoneExt":48,"email":96},"l.vd.hengel@nki.nl",{"type":98,"investigatorFullName":48,"investigatorTitle":48,"investigatorAffiliation":48,"oldNameTitle":48,"oldOrganization":48},"SPONSOR",[100,103],{"name":101,"class":102},"MRL Consortium","UNKNOWN",{"name":104,"class":105},"Elekta Limited","INDUSTRY","100623080",false,"NCT07391982","Dose De-escalation in Prostate Radiotherapy Using an MR-Linac in Two Fractions","Dose De-escalation in Prostate Radiotherapy Using an MR-Linac in 2 Fractions","DESTINATION 2","Inclusion Criteria:\n\n1. Men aged ≥18 years\n2. Histological confirmation of prostate adenocarcinoma requiring radical radiotherapy\n3. Gleason score 3+3, 3+4 or 4+3 (ISUP Grade groups (GG) 1, 2 or 3)\n4. MRI-visible tumour(s) of PIRADS v2 grade 3 or higher and able to be delineated on T2 and diffusion-weighted imaging +\u002F- dynamic contrast-enhanced imaging. Tumour nodule visible on MRI should be considered able to be boosted by treating clinician and \\\u003C2.5cm in maximal dimension. MRI must be performed within 3 months of trial entry\n5. The MRI-defined lesion must be confirmed as malignant on biopsies (any Gleason grade is sufficient as long as Gleason score is reported).\n6. MRI stages mT1 and T2 or mT3a with ≤ 1mm tumour outside gland AND otherwise favourable intermediate risk characteristics (Gleason 3+3, 3+4)(as staged by AJCC TNM 2018)\n7. PSA \\\u003C20 ng\u002Fml prior to starting androgen deprivation therapy (ADT).\n8. WHO Performance status 0-2\n9. Ability of the participant to understand and the willingness to sign a written informed consent (IC) form.\n10. Ability\u002Fwillingness to comply with the patient reported outcome questionnaires schedule throughout the study.\n\nExclusion Criteria:\n\n1. Contraindications to MRI (e.g. pacemaker, potentially mobile metal implant, claustrophobia)\n2. IPSS Score \\> 19\n3. High grade disease (GG3) occult to MRI-defined lesion. As a guide, any pathology for which you would consider surveillance is allowed outside of the MRI-defined area.\n4. Prostate volume \\>90cc\n5. Comorbidities which predispose to significant toxicity (e.g. inflammatory bowel disease) or preclude long term follow up\n6. Hip replacement, or other pelvic metalwork which causes artefact on diffusion-weighted imaging\n7. Previous pelvic radiotherapy\n8. Patients needing \\>6 months of ADT due to disease parameters.\n9. Previous invasive malignancy within the last 2 years excluding basal or squamous cell carcinomas of the skin, low risk non-muscle invasive bladder cancer (assuming cystoscopic follow up now negative) or small renal masses on surveillance.","MALE","18 Years",{"count":116,"type":117},54,"ESTIMATED","INTERVENTIONAL",[120],"NA","The goal of this clinical trial is to find out whether lowering the radiation dose to parts of the prostate without visible tumor on MRI can reduce side effects while still effectively treating prostate cancer in men with low or intermediate-risk prostate cancer.\n\nThe main questions it aims to answer are:\n\n* Does reducing the radiation dose to healthy prostate tissue lower the risk of bowel and urinary side effects?\n* Can we maintain good cancer control by keeping a high dose for MRI-visible tumor areas?\n\nResearchers will compare two treatment approaches:\n\n* One group receives a uniform high dose to the entire prostate.\n* The other group receives a lower dose to healthy prostate tissue and a high dose only to visible tumor areas.\n\nParticipants will:\n\n* Receive two sessions of MRI-guided radiotherapy using an MR-Linac.\n* Complete questionnaires about urinary, bowel, and sexual health before and after treatment.\n* Have follow-up visits to monitor side effects and PSA levels for up to 2 years.",[123],"Prostate Cancer (Adenocarcinoma)",[125,126,127],"De-escalation","Radiotherapy","MR-Linac","2026-02-02",{"date":130,"type":131},"2026-02-06","ACTUAL",{"date":133,"type":131},"2025-11-17",{"date":135,"type":117},"2028-12",{"name":5,"class":6},1]