Official Title
A Randomized Phase 3 Trial of Metformin in Patients Initiating Androgen Deprivation Therapy as Prevention and Intervention of Metabolic Syndrome: The Prime Study
Summary:
This is a multi-centre, double-blind, randomized phase III trial comparing metformin to placebo in patients with advanced prostate cancer starting (or have recently started) androgen deprivation therapy (ADT).
Trial Description
Primary Outcome:
- Proportion of participants who meet the diagnostic criteria for metabolic syndrome after 18 months of study treatment
Secondary Outcome:
- Proportion of participants who meet the diagnostic criteria for metabolic syndrome after 9 months of study treatment
- Proportion of participants who meet the diagnostic criteria for metabolic syndrome after 12 months of study treatment
- Proportion of participants who meet the diagnostic criteria for metabolic syndrome after 24 months of study treatment
- Proportion
of participants who meet the criteria of reduced high-density
lipoprotein cholesterol assessed at 18 months of follow-up.
- Proportion of participants who meet the criteria of elevated triglycerides assessed at 18 months of follow-up.
- Proportion of participants who meet the criteria of elevated blood pressure assessed at 18 months of follow-up.
- Proportion of participants who meet the criteria of elevated fasting blood glucose levels assessed at 18 months of follow-up.
- Proportion of participants who meet the criteria of increased waist circumference assessed at 18 months of follow-up.
- Health-related Quality of Life assessed at 18 months of follow-up.
- Treatment-related toxicity
The
primary objective of this study will determine if there are differences
between arms with respect to the proportion of participants who meet
the diagnostic criteria for metabolic syndrome after 18 months of study
treatment.
We will also compare arms with regards to severity of individual
metabolic syndrome components following 18 months of study treatment.
Other objectives are outlined below, and will include quality of life
assessments, metabolic and anthropomorphic measurements at additional
time points and correlative laboratory studies.
It
is estimated that one in seven Canadian men will be diagnosed with
prostate cancer in their lifetime. In 2015, approximately 23,600
Canadian men were estimated to be diagnosed with prostate cancer and
4,000 died of this disease.
Androgen deprivation therapy (ADT) is a standard first-line treatment
for men with incurable prostate cancer and has long been known to
improve overall survival.
Although the
effectiveness of ADT is well established in participants with advanced
prostate cancer, it is associated with important adverse effects as
outlined below. The development of metabolic syndrome in particular is
clinically important as it is associated with worsened quality of life
and increased all-cause morbidity and mortality.
As
ADT is now employed, alone or in combination with other therapies, in
virtually all men with advanced prostate cancer for increasingly long
periods of time (median survival of men presenting with newly diagnosed
metastatic disease from recent clinical trials is at least 3 years,
during which they are typically on continuous hormonal therapy), the
burden of ADT toxicity among men with prostate cancer is significant and
increasing.
The investigators hypothesize
that the addition of metformin to a program of ADT will reduce the
proportion of participants with metabolic syndrome at 18 months after
initiation of ADT and will reduce the severity of individual components
of metabolic syndrome in men with advanced prostate cancer. To test this
hypothesis, this is a randomized, double-blinded, placebo-controlled
phase 3 clinical trial of metformin in patients undergoing ADT
treatment.
View this trial on ClinicalTrials.gov
