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
Summary
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 therapyTime 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.
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Male.
Criteria:
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
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