2023-504704-28-00RecruitingPhase 2
Transdermal estradiol and exercise in mitigating adverse effects of androgen deprivation therapy for prostate cancer radiation therapy (ESTRACISE)
Central Finland Hospital District Central Finland Hospital Nova4 sites in 1 country310 target enrollmentStarted: August 21, 2023Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Enrollment
- 310
- Locations
- 4
- Primary Endpoint
- Primary endpoint will be the efficacy of transdermal estradiol in mitigating the sexual symptoms of ADT
Study Overview
Brief Summary
To estimate the efficacy of E2 in improving sexual dysfunction during ADT.
Eligibility Criteria
- Ages
- 18 years to 65+ years (65+ Years, 18-64 Years)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Primary endpoint will be the efficacy of transdermal estradiol in mitigating the sexual symptoms of ADT
Primary endpoint will be the efficacy of transdermal estradiol in mitigating the sexual symptoms of ADT
Secondary Outcomes
- Occurrence of ADT-induced adverse effects during ADT in different study groups
- Tolerability and safety of transdermal E2 during the one-year ADT adjuvant treatment period
- 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)
- Safety and tolerability of 6-month physical exercise combined with or without transdermal E2 during ADT
- Quality of life and perceived fatigue during ADT in different study groups
Investigators
Heikki Seikkula
Scientific
Central Finland Hospital District Central Finland Hospital Nova
Study Sites (4)
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