Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Active Comparator: Androgen deprivation therapy | Drug | — | UNRESOLVED |
| Resistance training | Behavioral | — | UNRESOLVED |
| Transdermal estrogen | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Transdermal estradiol
- description
- Participants (n=155) receiving transdermal estradiol and androgen deprivation therapy.
- interventionNames
- Drug: Transdermal estrogen
- Behavioral: Resistance training
- type
- ACTIVE_COMPARATOR
- label
- Androgen deprivation therapy
- description
- Participants (n=155) receiving solely androgen deprivation therapy.
- interventionNames
- Drug: Active Comparator: Androgen deprivation therapy
- Behavioral: Resistance training
Primary outcomes (1)
- measure
- The efficacy of transdermal estradiol in mitigating the deterioration of EPIC-26 (The Expanded Prostate Cancer Index Composite) sexual function domain scores caused by androgen deprivation therapy.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDJussila I, Ahtiainen JP, Laakkonen EK, Siltari A, Kaipia A, Jokela T, Karkkainen M, Newton R, Raastad T, Huhtala H, Murtola TJ, Seikkula H. Transdermal oestradiol and exercise in androgen deprivation therapy (ESTRACISE): protocol. BJU Int. 2024 Jul;134(1):110-118. doi: 10.1111/bju.16361. Epub 2024 Apr 8. PMID 38587276