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.
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
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
Parallel
Transdermal estrogen
DrugParticipants (n=155) receiving transdermal estradiol for 12 months.
Active Comparator: Androgen deprivation therapy
DrugParticipants (n=155) receiving solely androgen deprivation therapy for 12 months.
Resistance training
BehavioralParticipants (n=30 in each arm) performing supervised resistance training for six months.
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.
Compared between the two arms. Scores scaled from 0 - 100, higher score means better sexual function.
The occurrence of androgen deprivation therapy induced adverse effects.
Compared between different groups. Assessed by CTCAE (Common Termionology Criteria for Adverse Events). Number of participants with androgen deprivation therapy related adverse events, and grading of adverse event from 1 - 5. Higher grading indicates worse adverse event.
Number of participants with transdermal estradiol-related adverse events as assessed by CTCAE (Common Terminology Criteria for Adverse Events).
Transdermal estradiol arm. Number and grading of adverse events from 1 - 5. Higher grading means worse adverse event.
Impact of transdermal estradiol with or without 6-month supervised resistance training on one repetition maximum tests of both the leg press and barbell biceps curl, and maximal hand grip strength assessed with a dynamometer.
Compared between different groups. One repetition maximum tests and maximal hand grip strength assessed as kilograms or newtons. Higher kilograms or newtons indicates higher strength.
Impact of transdermal estradiol with or without 6-month supervised resistance training on explosive strength of the leg extensors assessed with a countermovement jump (CMJ).
Compared between different groups. From CMJ flight time is defined as milliseconds. Higher flight time in milliseconds represents higher jump height and explosive strength.
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Central Finland Hospital District
Lead sponsor
Tampere University
Collaborator
University of Jyvaskyla
Collaborator
Tampere University Hospital
Collaborator
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