protocolSection identificationModule nctId: NCT06276465, orgStudyIdInfo id: UC-GTG-2306, secondaryIdInfos id: 2023-507482-26-00, type: OTHER, domain: EU-CT, briefTitle: Treatment With Darolutamide +/- Radiation Therapy for Patients With a Castration Resistant Cancer and Metastases Detected by Functional Imaging, acronym: PEACE8, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2024-07-01, completionDateStruct date: 2032-07-01, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: UNICANCER, class: OTHER, collaborators name: Bayer, descriptionModule briefSummary: In earlier stages of prostate cancer, male sexual hormones (androgens) stimulate the growth of cancer cells. Castration-resistant prostate cancer (CRPC) means that the prostate cancer continued to grow despite patients are taking hormone therapy to control the disease. One of the standard treatments for these patients is so-called 'new generation' hormonal therapy. These hormone therapies include apalutamide, enzalutamide, or darolutamide. They work by blocking androgen receptors that play an important role in the growth of prostate cancer.In the case of oligometastatic CRPC, the cancer has gone beyond the prostate and has spread to other organs in the body (metastases), but these metastases remain limited in number.An early detection of the oligometastatic CRPC and appropriate treatment may prolong survival in these patients.The treatment proposed as part of this research is a combination of oral darolutamide, approved in Europe to treat patients with CRPC who do not have metastasis visible on CT-scan or bone scintigraphy (but visible with positron emission tomography-scan (PET-Scan), a more precise imaging technique) with stereotactic body radiotherapy (SBRT), a new radiotherapy technique guided by very high precision medical imaging. This method makes it possible to better target cancer cells while preserving neighboring healthy organs.The principal objective of this trial is to evaluate the efficacy of the combination of SBRT with darolutamide, compared to darolutamide., conditionsModule conditions: Prostatic Cancer, Castration-Resistant, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Eligible patients will be randomly allocated in a 1:1 ratio to either the:* Control arm: ADT + darolutamide.* Experimental arm: ADT + darolutamide + SBRT., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 336, type: ESTIMATED, armsInterventionsModule interventions name: Darolutamide 300 mg, interventions name: Stereotactic body radiation therapy, interventions name: Androgen deprivation therapy, outcomesModule primaryOutcomes measure: Radiographic Progression-free survival (rPFS), secondaryOutcomes measure: Time to treatment failure (TTF), secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Prostate cancer-specific survival, secondaryOutcomes measure: Time to PSA progression, secondaryOutcomes measure: Biochemical response rate, secondaryOutcomes measure: Time to next symptomatic skeletal event (SSE), secondaryOutcomes measure: Time to pain progression, secondaryOutcomes measure: Safety/tolerance, secondaryOutcomes measure: Functional Assessment of CAncer Therapy - Prostate (FACT-P), secondaryOutcomes measure: Brief Pain Inventory - Short Form (BP-SFI) questionnaire, eligibilityModule sex: MALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False