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Transdermal Estradiol and Exercise in Mitigating Adverse Effects of Androgen Deprivation Therapy for Prostate Cancer Radiation Therapy

NCT06271551 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 310

Last updated 2024-02-21

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Transdermal estrogen

Participants (n=155) receiving transdermal estradiol for 12 months.

DRUG

Active Comparator: Androgen deprivation therapy

Participants (n=155) receiving solely androgen deprivation therapy for 12 months.

BEHAVIORAL

Resistance training

Participants (n=30 in each arm) performing supervised resistance training for six months.

Sponsors & Collaborators

  • Tampere University

    collaborator OTHER

  • University of Jyvaskyla

    collaborator OTHER

  • Tampere University Hospital

    collaborator OTHER

  • Central Finland Hospital District

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-31
Primary Completion
2028-12-31
Completion
2029-12-31

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06271551 on ClinicalTrials.gov