Metabolic Effects of Treatment in Intermediate and High-Risk Prostate Cancer

NCT01599182 | Completed

• 2 other identifiers: 170742011-0454
• Study Type: observational
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

This study will work towards understanding the changes in your body (metabolism) that develop with treatment in prostate cancer. Hormonal therapies such as ADT often result in detrimental changes in body composition, including lean tissue loss and fat gains, compared to those patients receiving radiation therapy. These changes in body composition are linked to risk of diabetes and cardiovascular disease in survivorship. The investigators will be evaluating 50 patients to primarily examine the changes in metabolism, nutrition, physical function and body composition at the end of treatment, 6 weeks and 6 months following the end of treatment. Patients will continue to be followed every 6 months for up to 5 years following the end of treatment. The investigators findings will provide a new perspective for future work and novel approaches in the treatment of prostate cancer.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Change in Glucose Metabolism

  Oral glucose tolerance tests will be performed at each time point to assess changes in the body's ability to metabolize glucose. As such, other related parameters such as insulin and c-peptide will be measured to understand potential changes in glucose over the indicated time frame. As this is an observational study, safety issues are not anticipated. However, abnormal measures of glucose and insulin will be reported to a given participant's family physician.

  Baseline, 7 weeks, 30 weeks

Study Arms (2)

High-Risk Prostate Cancer

Intermediate-Risk Prostate Cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Intermediate and high risk prostate cancer patients with \>T2a or Gleason \> 6 or PSA \>10 would be offered participation in this study.

You may qualify if:

• Intermediate or high risk prostate cancer patients who have \>T2a or Gleason \>6 or PSA \>10
• Able to communicate in English
• Have sufficient cognitive ability to participate and provide informed consent

You may not qualify if:

• Any known diagnosis of cardiovascular disease, diabetes, HIV, uncompensated thyroid disease
• Pre-existing injuries or health conditions that prevents the patient's participation in exercise
• Any previous diagnosis of cancer or anti-neoplastic treatment (other than melanoma skin cancer) which is not in remission for at least 3 years

Sponsors & Collaborators

• University of Waterloo: lead
• Grand River Regional Cancer Centre: collaborator

Study Sites (1)

University of Waterloo

Waterloo, Ontario, N2L 3G1, Canada

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Measurements related to glucose, lipid and immune metabolism will be measured.

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Marina Mourtzakis, PhD

  University of Waterloo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2012
• First Posted: May 15, 2012
• Study Start: February 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: June 23, 2015

Record last verified: 2015-06

Locations

CA (1)