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Transdermal estradiol and exercise in mitigating adverse effects of androgen deprivation therapy for prostate cancer radiation therapy (ESTRACISE)
EU CTIS ID: 2023-504704-28-00
What this study is testing
To estimate the efficacy of E2 in improving sexual dysfunction during ADT.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.