Transdermal estradiol and exercise in mitigating adverse effects of androgen deprivation therapy for prostate cancer radiation therapy (ESTRACISE)
Key facts
- Where
- Jyvaskyla, Tampere és Turku, FinnországSee the 4 sites
- Phase
- 2. fázis
Where in Finnország
- Central Finland Hospital District Central Finland Hospital NovaJyvaskyla, FinnországTaking people
- University Of JyvaskylaJyvaskyla, FinnországTaking people
- Tampere University HospitalTampere, FinnországTaking people
- Varsinais-Suomen hyvinvointialueTurku, FinnországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Varsinais-Suomen hyvinvointialue
- Trial code
- EU 2023-504704-28-00
- Record updated
- 2026. október 7.
- Original description
To estimate the efficacy of E2 in improving sexual dysfunction during ADT.Read full original descriptionShow less
To estimate the efficacy of E2 in improving sexual dysfunction during ADT.
Inclusion: 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: Prior cardiovascular event or stroke (<12 months); Concurrent glucocorticoid treatment; Known allergy to estradiol or leuprorelin; Cardiac pacemaker; Diabetes Mellitus; Past or current venous thromboembolism; Other untreated or unstable malignancy in risk of recurrence/progression (as judged by the treating physician); 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); Patients with low-risk PCa; Physical disabilities for regular exercise; 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.