protocolSection identificationModule nctId: NCT06282185, orgStudyIdInfo id: CanisiusWH, briefTitle: SUPERvised Three-month Exercise Program in MEN With Prostate cAncer Receiving Androgen-deprivaTioN thERapy, acronym: Superman, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-05-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Canisius-Wilhelmina Hospital, class: OTHER, descriptionModule briefSummary: The goal of this single blind placebo-controlled intervention study is to examine the impact of a supervised training program on disease-related quality of life and physical fitness in patient with advanced prostate cancer compared to usual care. The main question\[s\] it aims to answer are:* What is the impact of exercise on quality of life* What is the impact of exercise on physical fitnessParticipants will have an individual training program with supervised training by physiotherapists.Researchers will compare with usual care to see if advice about exercise has significant less effect than an supervised training program., conditionsModule conditions: Prostatic Neoplasms, conditions: Metastasis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: randomized controlled trial with an intervention arm and an usual care group, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: In a single blinded (investigators blinded to group allocation) randomized controlled pilot, conducted in the CWZ, 20 patients with advanced prostate cancer will be randomized across: 1) supervised training program for twelve weeks + usual care + advice about exercise, or 2) usual care + advice about exercise., whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Physiotherapy, outcomesModule primaryOutcomes measure: change of quality of life assessed with EPIC26 (0-100 points), primaryOutcomes measure: change of quality of life assessed with EPIC26 (0-100 points), primaryOutcomes measure: change of quality of life assessed with EORTC QLQ-C30 (0-100 points per scale), primaryOutcomes measure: change of quality of life assessed with EORTC QLQ-C30 (0-100 points per scale), secondaryOutcomes measure: change of physical fitness in maximum uptake of oxygen in ml/kg/min, secondaryOutcomes measure: change of physical fitness in maximum uptake of oxygen in ml/kg/min, secondaryOutcomes measure: change of physical fitness in fat percentage, secondaryOutcomes measure: change of physical fitness in fat percentage, secondaryOutcomes measure: change of fitness assessed with IPAQ-sh (categories (1-3) and continues (MET-minutes)), secondaryOutcomes measure: change of fitness assessed with IPAQ-sh (categories (1-3) and continues (MET-minutes)), eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False