Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2025-12-24 @ 11:50 PM
NCT ID:
NCT06271551
Eligibility Criteria:
Inclusion Criteria:
* Men with localized prostate cancer, and scheduled for external beam radiation with adjuvant subcutaneous androgen deprivation therapy, leuprorelin (LHRH agonist) for at least 12 months without any other endocrinology treatments for prostate cancer
* Adults (age over 18 years)
* Sufficient performance status (Eastern Cooperative Oncology Group, 0-1)
* Body mass index between 18.5 - 30.0
* Willingness to participate and signed consent
Exclusion Criteria:
* Patients with low-risk prostate cancer (ISUP Gleason grade 1)
* Patients with expected adjuvant androgen deprivation therapy for less than one year
* Distant bone, lymph node, or soft tissue metastasis
* Cardiac pacemaker
* Prior recent 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
* 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
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT06271551
Study Brief:
Protocol Section:
NCT06271551