Prostate Cancer Clinical Trial

Staying Strong and Healthy During Androgen Deprivation Therapy (ADT) for Men

Summary

The purpose of this study is to learn if lifestyle changes and counseling along with standard medical care, compared to standard medical care alone, can prevent heart problems and diabetes in men who are receiving ADT for prostate cancer treatment.

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Full Description

Prostate cancer is a very treatable cancer but those treatments can have long-lasting effects. A kind of hormone therapy called Androgen Deprivation Therapy (ADT) is often used along with other treatments like radiation and has been shown to improve survival. However, ADT can have negative effects especially on the heart and metabolism (the body's system for using and storing energy).

Participation in this study will last for up to 12 months. The study is looking at two different approaches to treating men who are undergoing ADT:

Staying Strong & Healthy Intervention + Usual Care
Usual Care

All participants will have blood drawn and be asked questions about how they are feeling during their participation. The men in the Staying Strong & Healthy Intervention group will also take part in a diet and exercise program and receive counseling from a member of the study team.

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Eligibility Criteria

Inclusion Criteria:

Diagnosed with prostate cancer
Starting or have started ADT (oral or injection) for prostate cancer treatment within the last 3 months
Re-initiating ADT after being on holiday for longer than their ADT dosage (e.g. If the man's dosage is every six months and he has been off ADT for more than six he is eligible);
Able to speak and read in English or Spanish
Reachable consistently by telephone
Able to travel to KUMC

Exclusion Criteria:

Not diagnosed with prostate cancer
Not receiving or planning to receive ADT for prostate cancer treatment within the last three months
Initiating ADT for prostate cancer prior to the previous 3 months or are not on ADT holiday
Not able to speak and read in English or Spanish
Not reachable consistently by telephone
Not able to travel to the study site for data collection

Study is for people with:

Prostate Cancer

Estimated Enrollment:

38

Study ID:

NCT02969577

Recruitment Status:

Completed

Sponsor:

University of Kansas Medical Center

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There are 2 Locations for this study

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University of California, Los Angeles
Los Angeles California, 90095, United States
University of Kansas Medical Center
Kansas City Kansas, 66160, United States

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Study is for people with:

Prostate Cancer

Estimated Enrollment:

38

Study ID:

NCT02969577

Recruitment Status:

Completed

Sponsor:


University of Kansas Medical Center

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