Prostate Cancer Active Surveillance Metformin Trial

NCT01733836 | Withdrawn Phase 2 DMC

• 1 other identifier: MAS_001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (2)

• Primary Clinical Outcome - Inhibition of Prostate Cancer

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

  18 months

• Primary Scientific Endpoint - ki67 index

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

  18 months

Secondary Outcomes (4)

• Secondary Endpoint - Cell Cycle Proliferation (CCP) Score

  18 months

• Secondary Endpoint - Mechanism of Action

  18 months

• Secondary endpoint - Quality of Life

  18 months

• Secondary Endpoint - Prognostic Panel

  18 months

Study Arms (2)

Metformin

EXPERIMENTAL

850mg BID

Drug: Metformin

Placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

Metformin DRUG

Metformin

placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Total bilirubin less than 1.5 X institutional upper limit of normal (ULN)
• AST (SGOT)/ALT(SGPT) less than 1.5 X institutional ULN
• Alkaline phosphatase less than 2 X institutional ULN
• Creatinine less than 1.4 X institutional ULN
• Able to swallow and retain oral medication

You may not qualify if:

• 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
• Concurrent or planned participation in randomized trials of weight loss or exercise interventions or trials targeting insulin, IGF-1 or their receptors, or PI3K inhibitors.

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

University Health Network

Toronto, Ontario, M5G 2M9, Canada

Location

Related Publications (1)

• Roy S, Malone S, Grimes S, Morgan SC. Impact of Concomitant Medications on Biochemical Outcome in Localised Prostate Cancer Treated with Radiotherapy and Androgen Deprivation Therapy. Clin Oncol (R Coll Radiol). 2021 Mar;33(3):181-190. doi: 10.1016/j.clon.2020.09.005. Epub 2020 Sep 29.

  PMID: 32994091 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Metformin

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2012
• First Posted: November 27, 2012
• Study Start: January 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: May 24, 2013

Record last verified: 2013-05

Locations

CA (1)