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LIpitor and biGuanide to Androgen Delay Trial

Information source: University Health Network, Toronto
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Prostate Cancer

Intervention: Metformin (Drug); Atorvastatin (Drug); Placebo (corresponding to metformin) (Drug); Placebo (corresponding to atorvastatin) (Drug)

Phase: Phase 2

Status: Not yet recruiting

Sponsored by: University Health Network, Toronto

Official(s) and/or principal investigator(s):
Robert Hamilton, MD, MPH, FRCSC, Principal Investigator, Affiliation: University Health Network, Toronto
Neil Fleshner, MD, MPH, FRCSC, Principal Investigator, Affiliation: University Health Network, Toronto

Overall contact:
Karen Chadwick, Phone: 416-946-4501, Ext: 5259, Email: karen.chadwick@uhn.ca


This study is a randomized trial examining the administration of a combination of biguanide metformin and atorvastatin ("Lipitor") to men who are experiencing rising prostate-specific antigen (PSA) levels, despite having undergone radical therapy (surgery and/or radiation).

Clinical Details

Official title: A Randomized, Double Blind, Trial of Metformin and Atorvastatin in Delaying Androgen Deprivation Therapy Among Men With Rising PSA Following Radical Prostatectomy or Radiotherapy: The LIGAND (LIpitor and biGuanide to Androgen Delay) Trial

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Time to disease progression (defined as PSA rise to 10 ng/mL or greater, development of clinically overt metastases) or patient/physician desire for androgen deprivation therapy.

Secondary outcome:

Time to androgen deprivation therapy

Time to PSA progression

Time to disease progression

Body mass index

Circulating glycated hemoglobin levels

C-peptide levels

Adipokine levels

LDL/HDL cholesterol levels

Triglyceride levels

Incidence of adverse events during administration of metformin and atorvastatin to men with prostate cancer.


Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Male.


Inclusion Criteria:

- Willing and able to provide informed consent

- Histologically confirmed adenocarcinoma of the prostate

- History of radical therapy (i. e., radical prostatectomy, radiotherapy, brachytherapy

or prostatectomy with salvage radiotherapy)

- Serum testosterone levels 8. 0 nmol/L (230 ng/dL) or greater

- Not currently undergoing treatment for hyperlipidemia or diabetes mellitus

- LDL-cholesterol levels 5 mmol/L or lower

- HgA1c 6. 5% or lower

- PSA levels between 2 and 5 ng/mL

Exclusion Criteria:

- Subjects that have been treated for prostate cancer with any of the following:

i. Cytotoxic chemotherapy; ii. Hormonal therapy within past 3 years; iii. Oral glucocorticoids; iv. Gonadotropin-releasing hormone (GnRH) analogues (e. g., leuprolide, goserelin, degarelix)

- Past treatment with the 5-α reductase inhibitors finasteride and dutasteride within

past 5 years

- Past treatment with drugs with antiandrogenic properties (e. g., flutamide,

bicalutamide, ketoconazole, progestational agents) within 6 months prior to screening

- Use of metformin or statins within past 2 years

- Planned or concurrent use of metformin, sulfonylureas, thiazolidinediones or insulin

for any reason

- Known hypersensitivity or intolerance to metformin or atorvastatin

- Any clinically significant laboratory abnormalities (e. g., severe renal or hepatic

impairment) which in the judgment of the investigator would affect the patient's health or the outcome of the trial

- Any condition associated with increased risk of metformin-associated lactic acidosis

(e. g., congestive heart failure defined as New York Heart Association (NYHA) class III or IV, history of any type of acidosis, habitual intake of 4 or more alcoholic beverages per day)

- Abnormal liver function test

- Abnormal organ and marrow function

Locations and Contacts

Karen Chadwick, Phone: 416-946-4501, Ext: 5259, Email: karen.chadwick@uhn.ca

Princess Margaret Cancer Centre, Toronto, Ontario M5G 2M9, Canada; Not yet recruiting
Robert Hamilton, MD, MPH, FRCSC, Principal Investigator
Neil Fleshner, MD, MPH, FRCSC, Principal Investigator
Additional Information

Starting date: August 2015
Last updated: July 14, 2015

Page last updated: August 23, 2015

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