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Transdermal Estradiol and Exercise in Mitigating Adverse Effects of Androgen Deprivation Therapy for Prostate Cancer Radiation Therapy
Sponsor: Central Finland Hospital District
Summary
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.
Official title: Transdermal Estradiol and Exercise in Mitigating Adverse Effects of Androgen Deprivation Therapy for Prostate Cancer Radiation Therapy: A Randomized Controlled Trial
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
310
Start Date
2024-03
Completion Date
2029-12
Last Updated
2024-02-21
Healthy Volunteers
No
Conditions
Interventions
Transdermal estrogen
Participants (n=155) receiving transdermal estradiol for 12 months.
Active Comparator: Androgen deprivation therapy
Participants (n=155) receiving solely androgen deprivation therapy for 12 months.
Resistance training
Participants (n=30 in each arm) performing supervised resistance training for six months.