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

18 Years
Open (Enrolling)
Prostate Cancer

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Trial Information

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

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

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.

Inclusion Criteria:

- Intermediate or high risk prostate cancer patients who have >T2a or Gleason >6 or PSA

- 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

- 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

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Change in Glucose Metabolism

Outcome Description:

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.

Outcome Time Frame:

Baseline, 7 weeks, 30 weeks

Safety Issue:


Principal Investigator

Marina Mourtzakis, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Waterloo


Canada: Health Canada

Study ID:




Start Date:

February 2012

Completion Date:

December 2014

Related Keywords:

  • Prostate Cancer
  • Prostatic Neoplasms