protocolSection identificationModule nctId: NCT06271551, orgStudyIdInfo id: ESTRACISE, briefTitle: Transdermal Estradiol and Exercise in Mitigating Adverse Effects of Androgen Deprivation Therapy for Prostate Cancer Radiation Therapy, acronym: ESTRACISE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2028-12, completionDateStruct date: 2029-12, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Central Finland Hospital District, class: OTHER, collaborators name: Tampere University, collaborators name: University of Jyvaskyla, collaborators name: Tampere University Hospital, descriptionModule briefSummary: The goal of the clinical trial is to find out whether transdermal estradiol will reduce the adverse effects of androgen deprivation therapy in prostate cancer patients.The primary aim of this study is to estimate the efficacy of transdermal estradiol (E2) in reducing androgen deprivation therapy induced adverse effects on sexual function. A secondary aim of this study is to estimate the utility of E2 and the combination of E2 with supervised exercise in reducing other androgen deprivation therapy related adverse effects.Participants (n=310) will use transdermal estradiol for 12 months concomitant to androgen deprivation therapy. The use of transdermal estradiol will start at the beginning of the trial, at the same time as androgen deprivation therapy. A subgroup of participants (n=120) will also be allocated to perform six months supervised resistance training.Researchers will compare transdermal estradiol group to control group, and resistance training groups and non-training control groups., conditionsModule conditions: Prostate Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants are randomized in a 1:1 fashion to receive transdermal estradiol and androgen deprivation or solely androgen deprivation therapy. In addition subgroup of participants are randomized in a 1:1 fashion to perform resistance training or to be allocated in non-training control group., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 310, type: ESTIMATED, armsInterventionsModule interventions name: Transdermal estrogen, interventions name: Active Comparator: Androgen deprivation therapy, interventions name: Resistance training, outcomesModule primaryOutcomes measure: The efficacy of transdermal estradiol in mitigating the deterioration of EPIC-26 (The Expanded Prostate Cancer Index Composite) sexual function domain scores caused by androgen deprivation therapy., secondaryOutcomes measure: The occurrence of androgen deprivation therapy induced adverse effects., secondaryOutcomes measure: Number of participants with transdermal estradiol-related adverse events as assessed by CTCAE (Common Terminology Criteria for Adverse Events)., secondaryOutcomes measure: Impact of transdermal estradiol with or without 6-month supervised resistance training on one repetition maximum tests of both the leg press and barbell biceps curl, and maximal hand grip strength assessed with a dynamometer., secondaryOutcomes measure: Impact of transdermal estradiol with or without 6-month supervised resistance training on explosive strength of the leg extensors assessed with a countermovement jump (CMJ)., secondaryOutcomes measure: Impact of transdermal estradiol with or without 6-month supervised resistance training on 6-minute walk (functional capacity)., secondaryOutcomes measure: Impact of transdermal estradiol with or without 6-month supervised resistance training on loaded 10-stair climb test (functional capacity)., secondaryOutcomes measure: Impact of transdermal estradiol with or without 6-month supervised resistance training on body composition., secondaryOutcomes measure: Impact of transdermal estradiol with or without 6-month supervised resistance training on bone mineral density., secondaryOutcomes measure: Impact of transdermal estradiol with or without 6-month supervised resistance training on mid-thigh muscle mass., secondaryOutcomes measure: Impact of transdermal estradiol with or without 6-month supervised resistance training on mid-thigh fat mass., secondaryOutcomes measure: Impact of transdermal estradiol with or without 6-month supervised resistance training on hormone (testosterone and estradiol) levels, and cancer (PSA) status., secondaryOutcomes measure: Impact of transdermal estradiol with or without 6-month supervised resistance training on concentration of PVK, IL-6, TNF-α, AFOS, Alat, Krea, Cholesterol, LDL-C, HDL-C, and triglycerides)., secondaryOutcomes measure: Impact of transdermal estradiol with or without 6-month supervised resistance training on type I and II myofibers' cross-sectional area, myonuclei, myonuclear domain, the satellite cell count, androgen receptor and myostatin content, secondaryOutcomes measure: Impact of transdermal estradiol with or without 6-month supervised resistance training on muscle cellular function (e.g., HSP70, alpha B-crystallin, HSP60, cytochrome c oxidase subunit IV proteins), secondaryOutcomes measure: Number of participants with resistance training induced adverse events., secondaryOutcomes measure: The World Health Organization Quality of Life Brief Version (WHOQOL-BREF)., secondaryOutcomes measure: The Patient Health Questionnaire score (PHQ-9) overall and subdomain score., eligibilityModule sex: MALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False