NCT06271551Not yet recruitingPhase 2
Transdermal Estradiol and Exercise in Mitigating Adverse Effects of Androgen Deprivation Therapy for Prostate Cancer Radiation Therapy
Transdermal Estradiol and Exercise in Mitigating Adverse Effects of Androgen Deprivation Therapy for Prostate Cancer Radiation Therapy: A Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 21 Feb 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The goal of the clinical trial is to find out whether transdermal estradiol will reduce the adverse effects of androgen deprivation therapy in prostate cancer patients. The primary aim of this study is to estimate the efficacy of transdermal estradiol (E2) in reducing androgen deprivation therapy induced adverse effects on sexual function. A secondary aim of this study is to estimate the utility of E2 and the combination of E2 with supervised exercise in reducing other androgen deprivation therapy related adverse effects. Participants (n=310) will use transdermal estradiol for 12 months concomitant to androgen deprivation therapy. The use of transdermal estradiol will start at the beginning of the trial, at the same time as androgen deprivation therapy. A subgroup of participants (n=120) will also be allocated to perform six months supervised resistance training. Researchers will compare transdermal estradiol group to control group, and resistance training groups and non-training control groups.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 310 (estimated)
- First submitted
- 20 Nov 2023
- Start date
- Mar 2024
- Primary completion date
- Dec 2028
- Lead sponsor
- Central Finland Hospital District
- Diseases
- Prostate cancer
- NCT number
- NCT06271551
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 310
- From Mar 2024 to the primary completion date, Dec 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with expected adjuvant androgen deprivation therapy for less than one year
- Prior recent cardiovascular event or stroke (\<12 months)
- Concurrent glucocorticoid treatment
Other illness
- Patients with low-risk prostate cancer (ISUP Gleason grade 1)
- Cardiac pacemaker
- Past or current venous thromboembolism
- Other untreated or unstable malignancy in risk of recurrence/progression (as judged by the treating physician)
- Known allergy to estradiol or leuprorelin
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
- Distant bone, lymph node, or soft tissue metastasis
- Physical disabilities for regular exercise
- Expected poor compliance or expected survival time of less than one year
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.