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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01599182
• Other study ID #: 17074
• Secondary ID: 2011-0454
• Status: Completed
• Phase: N/A
• First received: February 20, 2012
• Last updated: June 22, 2015
• Start date: February 2012
• Est. completion date: December 2014

Study information

• Verified date: June 2015
• Source: University of Waterloo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Observational

Clinical Trial 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.

Description:

Intermediate and high risk prostate cancer patients generally undergo either watchful waiting, surgery, RT alone or RT in conjunction with androgen deprivation therapy (ADT). Prostate cancer patients who receive upfront ADT exhibit drastic reductions in testosterone, resulting in the loss of a key anabolic signal and ultimately muscle loss and adipose tissue gain. In non-malignant populations, these changes in body composition are associated with the development of insulin resistance and metabolic syndrome. Hypogonadism is also independently predictive of hyperinsulinemia and metabolic syndrome, and may be the consequence of ADT, increased saturated fat intake, inactivity as well as unhealthy changes in body composition during the treatment time-course. However, it is thought that obesity itself is associated with atherogenic profiles, insulin resistance, biochemical failure, increased risk of cancer recurrence and/or metabolic syndrome in prostate cancer. The loss of muscle is largely attributed to reduced anabolic stimulus due to inactivity and reduced androgen hormones from ADT. As skeletal muscle has an important role in glucose disposal, using RT alone does not reduce androgen hormone levels and may maintain muscle mass to prevent the deleterious metabolic effects exhibited with ADT. Thus, different forms of therapy may present with diverse changes in body composition and ultimately metabolic implications.

While there are discrepancies in the success of ADT therapy, this form of therapy invariably results in several detrimental metabolic changes that predispose prostate cancer patients and survivors to developing chronic diseases such as diabetes and cardiovascular disease as well as a greater risk of cancer recurrence. In fact, prostate cancer patients who undergo radical prostatectomy and androgen deprivation therapy, not only lose muscle mass while undergoing treatment but also develop a greater risk of mortality from cardiovascular disease as compared to prostate cancer patients receiving other forms of therapy. To date, no studies have examined the metabolic effects that develop with ADT and/or radiation therapy. The results of the proposed study will indicate the potential metabolic changes that develop with therapy. It is important to identify these unhealthy changes early so that specific nutrition and exercise protocols may be used to improve clinical outcomes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Locations

Country	Name	City	State
Canada	University of Waterloo	Waterloo	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University of Waterloo	Grand River Regional Cancer Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No