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

Recruitment & Eligibility

Status: ot Recruiting

Sex: Male

Target Recruitment: 310

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To estimate the efficacy of E2 in improving sexual dysfunction during ADT.;Secondary Objective: To investigate the occurrence of ADT-induced adverse effects during ADT, To estimate the safety and tolerability of transdermal E2 during ADT treatment of PCa, To estimate the impact of E2 with or without resistance training in mitigating the adverse effects of ADT on physical performance, body composition, and systematic biomarkers, To estimate the safety and tolerability of resistance training with or without transdermal E2 during ADT, To investigate the impact of transdermal E2 with or without resistance training on quality of life and perceived fatigue during ADT;Primary end point(s): Primary endpoint will be the efficacy of transdermal estradiol in mitigating the sexual symptoms of ADT

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):Occurrence of ADT-induced adverse effects during ADT in different study groups;Secondary end point(s):Tolerability and safety of transdermal E2 during the one-year ADT adjuvant treatment period;Secondary end point(s):Impact of transdermal E2 with or without 6-month resistance exercise on the muscle strength, functional capacity, body composition, lean-body muscle mass, and systematic biomarkers (g.e., blood biomarkers of and inflammatory health and muscle biomarkers);Secondary end point(s):Safety and tolerability of 6-month physical exercise combined with or without transdermal E2 during ADT;Secondary end point(s):Quality of life and perceived fatigue during ADT in different study groups

Related Trials