2023-504704-28-00RecruitingPhase 2
Transdermal estradiol and exercise in mitigating adverse effects of androgen deprivation therapy for prostate cancer radiation therapy (ESTRACISE)
Source: EU CTIS (euclinicaltrials.eu) · Last updated 7 Oct 2026
Brief summary (registry, in English)
To estimate the efficacy of E2 in improving sexual dysfunction during ADT.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 310 (estimated)
- First submitted
- 6 Jun 2023
- Start date
- 1 Sept 2024
- Lead sponsor
- Varsinais-Suomen hyvinvointialue
- Diseases
- Prostate cancer
- EU CT number
- 2023-504704-28-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 310
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for men with prostate cancer that has not spread, who are starting radiotherapy together with hormone treatment (ADT) for at least one year.
- Age
- Over 18 years.
- Sex
- Men only.
- Disease stage
- Localized prostate cancer, not low-risk, with no distant metastasis in bone, lymph nodes or soft tissue.
- Earlier treatment
- Starting radiotherapy with adjuvant ADT for at least one year. No ongoing glucocorticoid treatment.
Main reasons for not taking part
- Low-risk prostate cancer
- Diabetes mellitus
- Past or current venous thromboembolism, or a heart event or stroke in the last 12 months
- Cardiac pacemaker
- Allergy to estradiol or leuprorelin, or a condition or medicine that rules out estradiol or leuprorelin
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior cardiovascular event or stroke (<12 months)
- Concurrent glucocorticoid treatment
Other illness
- 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)
Lab values
- 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)
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Of Jyvaskyla | Jyvaskyla | Finland | Recruiting |
| Central Finland Hospital District Central Finland Hospital Nova | Jyvaskyla | Finland | Recruiting |
| Tampere University Hospital | Tampere | Finland | Recruiting |
| Varsinais-Suomen hyvinvointialue | Turku | Finland | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.