Transdermal estradiol and exercise in mitigating adverse effects of androgen deprivation therapy for prostate cancer radiation therapy (ESTRACISE) - ESTRACISE

Central Finland Hospital District Central Finland Hospital Nova0 个研究点目标入组 310 人开始时间: 2023年6月6日最近更新: 2024年7月22日

适应症

试验速览

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•Men with localized PCa starting radiotherapy with adjuvant ADT at least for one year, Adults (age over 18 years), Sufficient performance status ECOG 0-1, Willingness to participate and signed consent, Body mass index between 18.5 – 30.0

•Patients with low-risk PCa, Physical disabilities for regular exercise, Any medication or condition considered as a contraindication to estradiol (allergy to adjuvant compounds (carbomer, trolamine), history with thromboembolic disorders (protein C, protein S, or antithrombin deficiency), porphyria, acute or previous liver disease, drugs with cytochrome P450 enzyme metabolism (anticonvulsants: phenobarbital, phenytoin, carbamazepine; anti-infectives: rifampicin, rifapentine, nevirapine, efavirenz; and St. John's wort)) or leuprorelin (allergy to adjuvant compounds (polylactic acid), Qt-time prolonging drugs (quinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide, methadone, moxifloxacin, antipsychotics), Known allergy to estradiol or leuprorelin, Expected poor compliance or expected survival time of less than one year, Patients with expected adjuvant ADT for less than one year, Distant bone, lymph node, or soft tissue metastasis, Cardiac pacemaker, Diabetes Mellitus, Prior cardiovascular event or stroke (<12 months), Past or current venous thromboembolism, Other untreated or unstable malignancy in risk of recurrence/progression (as judged by the treating physician), Concurrent glucocorticoid treatment

发起方

Central Finland Hospital District Central Finland Hospital Nova