Status:
COMPLETED
PCa Patients Managed With ADT to Examine the Effect of Nutritional Guidance and Aerobic/Resistance Fitness Training
Lead Sponsor:
CMX Research
Collaborating Sponsors:
Sanofi
Conditions:
Cancer of the Prostate
Eligibility:
MALE
18+ years
Brief Summary
The purpose of this observational study is to examine the level of activity in the prostate cancer population treated with Androgen Deprivation Therapy (ADT).
Detailed Description
The aim of the current observational study will be to examine the level of activity in the prostate cancer population treated with ADT therapy; specifically, the impact of physical activity levels alo...
Eligibility Criteria
Inclusion
- Male patient aged ≥ 18 years old
- Able to read and sign an approved Informed Consent Form (ICF)
- Diagnosed with locally advanced or metastatic prostate cancer
- Patient is treatment naive for ADT or has started ADT (3 or 4 month depot injection) AND has not received more than 1 treatment of 3 or 4 month ADT OR Patient is on intermittent therapy with an ADT agent and will be restarting ADT (3 or 4 month depot injection)
- ECOG (Eastern Cooperative Oncology Group) score of ≤ 2
- Willingness to track weekly physical activities with or without participating in a home based exercise program during the course of this study. The physical activities will be tracked with a weekly activity log or a NIKE+ Fuelband
Exclusion
- Currently participating in a clinical study or observational study
- Has a survival expectancy of \< 2 years
- Has any other condition that, in the opinion of the treating physician, may affect the patient's health or outcome of the trial
Key Trial Info
Start Date :
November 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2020
Estimated Enrollment :
271 Patients enrolled
Trial Details
Trial ID
NCT04057859
Start Date
November 1 2013
End Date
July 1 2020
Last Update
January 24 2022
Active Locations (23)
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1
Southern Interior Medical Research Inc.
Kelowna, British Columbia, Canada, V1W 4V5
2
Silverado Research Inc.
Victoria, British Columbia, Canada, V8T 2C1
3
Barrie Urology Group
Barrie, Ontario, Canada, L4M 7G1
4
Euroscope Inc.
Barrie, Ontario, Canada, L4M 7G1