protocolSection identificationModule nctId: NCT06330909, orgStudyIdInfo id: P003103, secondaryIdInfos id: DRKS00022915, type: OTHER, domain: Deutsches Register Klinische Studien, briefTitle: Image-guided Focal Dose Escalation- Primary pc Treated With Primary External Beam Hypofract.Stereotactic rt, acronym: HypoF-SBRT, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-08-18, primaryCompletionDateStruct date: 2025-08, completionDateStruct date: 2030-02, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: University Hospital Freiburg, class: OTHER, collaborators name: German Federal Ministry of Education and Research, descriptionModule briefSummary: Technical advances in radiotherapy (RT) treatment planning and delivery have substantially changed RT concepts for primary prostate cancer (PCa) by (i) enabling a reduction of treatment time and by (ii) enabling a safe delivery of high RT doses. Several studies proposed a dose-response relationship for patients with primary prostate cancer (PCa) and especially in patients with high-risk features a dose escalation should lead to improved tumor control. In parallel to the improvements in RT techniques, diagnostic imaging techniques like multiparametric magnetic resonance imaging (mpMRI) and positron-emission tomography (PET) evolved and enable an accurate depiction of the intraprostatic tumor mass for the first time. The HypoFocal-SBRT study combines ultra-hypofractionated RT / stereotactic body RT (reduction of treatment time) with a focal RT dose escalation on intraprostatic tumor sides by applying state of the art diagnostic imaging and most modern RT concepts. This novel concept will be compared with moderate hypofractionated RT (MHRT), one option for the curative primary treatment of PCa, which has been proven by several prospective trials and is recommended and carried out worldwide. We suspect an increase in relapse-free survival (RFS) and we will also assess quality of life in order to detect potential changes., conditionsModule conditions: Prostate Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This is a prospective, randomized two arm phase III multicentre trial comparing image-guided focal dose escalation using SBRT in patients with primary PCa treated with primary external beam hypofractionated radiation therapy.Patients will be randomized to either arm A (experimental intervention) or arm B (control intervention)., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 374, type: ESTIMATED, armsInterventionsModule interventions name: Radiotherapy (RT) Arm A - IMRT/IGRT/SBRT, interventions name: Radiotherapy (RT) Arm B - IMRT/IGRT, outcomesModule primaryOutcomes measure: Relapse free survival, secondaryOutcomes measure: Time to local failure after randomization, secondaryOutcomes measure: Metastatic free survival after randomization, secondaryOutcomes measure: Overall (OS) and prostate cancer specific (PCSS) survival after randomization, secondaryOutcomes measure: Time to biochemical failure (phoenix definition) after randomization, secondaryOutcomes measure: Patient reported acute quality of life (QOL) - Expanded Prostate Index Composite-26 (EPIC-26), secondaryOutcomes measure: Patient reported late quality of life (QOL), secondaryOutcomes measure: Cumulative acute GU and GI toxicities during and up to 3 months after RT using the CTCAEv5.0 criteria, secondaryOutcomes measure: Cumulative Chronic GU and GI toxicities after RT using the CTCAEv5.0 criteria, secondaryOutcomes measure: Dose constraints and prescription doses / recruited patients, secondaryOutcomes measure: Characterization of safety: adverse events, eligibilityModule sex: MALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Medical Center - University of Freiburg, status: RECRUITING, city: Freiburg, state: Baden-Württemberg, zip: 79106, country: Germany, geoPoint lat: 47.9959, lon: 7.85222, hasResults: False