A Randomized Double Blind Placebo Controlled Single Institution Phase 2 Study of Metformin in Patients Undergoing Active Surveillance for Prostate Cancer.

University Health Network, Toronto1 site in 1 countryJanuary 2013

ConditionsProstate Cancer

InterventionsMetformin placebo

DrugsMetformin placebo

Overview

Phase: Phase 2
Intervention: Metformin
Conditions: Prostate Cancer
Sponsor: University Health Network, Toronto
Locations: 1
Primary Endpoint: Primary Clinical Outcome - Inhibition of Prostate Cancer
Status: Withdrawn
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

To determine whether the use of metformin in patients with low-risk prostate cancer can delay progression to clinically significant prostate cancer.

Registry

clinicaltrials.gov

Start Date

January 2013

End Date

October 2014

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

University Health Network, Toronto

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Willing and able to provide informed consent
•Men \>= 18 years of age, and less than 80
•Men with biopsy proven, low-risk, localized prostate cancer (as defined below)
•Men choosing expectant management as primary treatment for prostate cancer
•Diagnostic biopsy performed within 4 months of screening visit
•Gleason score ≤ 6 in 3 cores or less with no Gleason pattern 4, less than 50% of any core involved in cancer
•Clinical stage T1c-T2a (Initial diagnosis of T1a/T1b obtained during a TURP is not allowed)
•Serum PSA ≤10 ng/mL
•Life expectancy greater than 5 years
•Normal kidney and hepatic function as defined by the following criteria:

Exclusion Criteria

•Any previous prostate cancer treatment (radiotherapy, chemotherapy, hormonal therapy, oral glucocorticoids, GnRH analogues)
•Diabetes including type 1 diabetes. Patients with known type 2 diabetes are eligible provided they have not been on metformin during the previous 12 months and are not on any other pharmacological agents.
•Concurrent or previous use of anabolic steroids or drugs with anti androgenic properties including 5-ARIs (dutasteride and finasteride)
•Prostate volume greater than 80 cc. (as per TRUS biopsy report)
•Prostatic surgery or procedure within 3 months of screening visit
•Severe BPH symptoms (IPSS ≥25, or ≥20 if already on α-blocker therapy)
•Other malignancies, with the exception of adequately treated nonmelanoma skin cancer, NMIBC or other solid tumors curatively treated with no evidence of disease for ≥ 5 years
•Planned or concurrent participation in other interventional randomized trials including exercise
•The presence of any other coexistent medical condition that in the opinion of the investigator would have the potential to significantly limit adherence to medication, or ability to absorb the medication including but not limited to psychiatric conditions, malabsorption syndromes or severe ischemic heart disease
•Known hypersensitivity or intolerance to metformin

Arms & Interventions

Metformin

850mg BID

Intervention: Metformin

Placebo

Intervention: placebo

Outcomes

Primary Outcomes

Primary Clinical Outcome - Inhibition of Prostate Cancer

Time Frame: 18 months

To assess the role of metformin on the inhibition of low-risk localized prostate cancer progression in men undergoing active surveillance for prostate cancer.

Primary Scientific Endpoint - ki67 index

Time Frame: 18 months

To assess the effect of metformin on the cell cycle proliferation indices (ki67 index).