Status:
TERMINATED
A Study of Pre-operative Metformin in Prostate Cancer
Lead Sponsor:
University Health Network, Toronto
Collaborating Sponsors:
Jewish General Hospital
Conditions:
Prostate Cancer
Eligibility:
MALE
18-75 years
Phase:
PHASE2
Brief Summary
This study will investigate the effect of neoadjuvant metformin therapy in the inhibition of growth and proliferation of prostate cancer cells prior to radical prostatectomy.
Detailed Description
Prostate cancer is the most commonly diagnosed malignancy in men in North America, with close to a quarter of a million cases diagnosed in 2007 alone (Joshua et al, 2007). The activation of the PTEN/ ...
Eligibility Criteria
Inclusion
- 1\. Patients with histologically confirmed prostate cancer involving at least 20% of at least one unfragmented biopsy core;
- Over the age of 18 and under the age of 75;
- Ability to read and understand the consent form, either alone or with the aid of a translator
- ECOG performance status less than or equal to 2 (Karnofsky greater than or equal to 60%);
- Patients must have their TRUS biopsy performed at UHN (or at an outside institution if tissue accession can be arranged) in the last 3 months;
- Patients must have normal organ and marrow function as defined by the following criteria:
- Absolute neutrophil count greater than or equal to 1,500/uL
- Platelets greater than or equal to 100,000/uL
- Total bilirubin less than or equal to 1.5 X institutional ULN
- AST(SGOT)/ALT(SGPT) less than or equal to 1.5 X institutional ULN
- Creatinine less than or equal to 1.4 X institutional ULN
Exclusion
- Patients who on initial assessment are found to be on treatment with any drug used for the treatment of any form of diabetes, or patients that begin treatment for any form of diabetes during the course of the study;
- Patients may not be receiving any other investigational, herbal or anticancer agents while on study;
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, congestive heart failure (NYHA Class 3 or greater), cirrhosis with a Child-Pugh level of B or greater or evidence of cardiac dysfunction, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease, clinically significant gastrointestinal conditions (e.g. Crohns disease, ulcerative colitis), COPD or psychiatric illness/social situations that would limit compliance with study requirements;
- Active malignancy at any other site excluding squamous cell or basal cell carcinomas of the skin
- Radiotherapy within the past 4 weeks;
- Patients with a current history of alcohol intake (\>2 standard drinks/day) or binge drinking (5 or more drinks (male), or 4 or more drinks (female)) in one session of 1-3 hours;
- Past history of lactic acidosis or risk factors for lactic acidosis such as congestive heart failure (NYHA Class 3 or greater), hypoxia (resting PO2 \< 91%) or renal insufficiency (eGFR \< 60 mls/min)
- Patients taking systemic glucocorticoids or estrogenic compounds.
- Patients with known hypersensitivity or allergy to metformin or any of its excipients.
- Patients with a history of impaired liver or kidney function.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00881725
Start Date
June 1 2009
End Date
June 1 2012
Last Update
June 19 2012
Active Locations (1)
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1
University Health Network
Toronto, Ontario, Canada, M5G2M9