Not provided
Not provided
Not provided
Not provided
Drug intervention no longer relevant for the proposed population
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metformin and Atorvastatin | Experimental | Atorvastatin 20 mg once daily until progression with one month run-in of 850 mg metformin once daily, followed by 850 mg twice daily of metformin until progression. |
|
| Placebo | Placebo Comparator | One placebo tablet (corresponding to atorvastatin) once daily until progression, with one month of one placebo tablet (corresponding to metformin) once daily, followed by one placebo tablet twice daily until progression. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin | Drug | One month run-in of 850 mg metformin once daily, followed by 850 mg twice daily of metformin until progression. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From date of randomization until the date of progression or patient/physician desire for androgen deprivation therapy, whichever comes first, assessed up to 36 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to androgen deprivation therapy | From date of randomization until the date of progression or patient/physician desire for androgen deprivation therapy, whichever comes first, assessed up to 36 months. | |
| Time to PSA progression | From date of randomization until the date of progression or patient/physician desire for androgen deprivation therapy, whichever comes first, assessed up to 36 months. |
Not provided
Inclusion Criteria:
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Robert Hamilton, MD, MPH, FRCSC | University Health Network, Toronto | Principal Investigator |
| Neil Fleshner, MD, MPH, FRCSC | University Health Network, Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Princess Margaret Cancer Centre | Toronto | Ontario | M5G 2M9 | Canada |
Not provided
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D008687 | Metformin |
| D001645 | Biguanides |
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D011758 | Pyrroles |
| D001393 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Atorvastatin | Drug | Atorvastatin 20 mg once daily until progression. |
|
|
| Placebo (corresponding to metformin) | Drug | One month of one placebo tablet (corresponding to metformin) once daily, followed by one placebo tablet twice daily until progression. |
|
| Placebo (corresponding to atorvastatin) | Drug | One placebo tablet (corresponding to atorvastatin) once daily until progression. |
|
| Time to disease progression | From date of randomization until the date of progression or patient/physician desire for androgen deprivation therapy, whichever comes first, assessed up to 36 months. |
| Body mass index | Relationship between body mass index and response to anti-metabolic and anti-cholesterol therapy | From date of randomization until the date of progression or patient/physician desire for androgen deprivation therapy, whichever comes first, assessed up to 36 months. |
| Circulating glycated hemoglobin levels | Relationship between circulating glycated hemoglobin levels and response to anti-metabolic and anti-cholesterol therapy | From date of randomization until the date of progression or patient/physician desire for androgen deprivation therapy, whichever comes first, assessed up to 36 months. |
| C-peptide levels | Relationship between C-peptide levels and response to anti-metabolic and anti-cholesterol therapy | From date of randomization until the date of progression or patient/physician desire for androgen deprivation therapy, whichever comes first, assessed up to 36 months. |
| Adipokine levels | Relationship between adipokine levels and response to anti-metabolic and anti-cholesterol therapy | From date of randomization until the date of progression or patient/physician desire for androgen deprivation therapy, whichever comes first, assessed up to 36 months. |
| LDL/HDL cholesterol levels | Relationship between LDL/HDL cholesterol levels and response to anti-metabolic and anti-cholesterol therapy | From date of randomization until the date of progression or patient/physician desire for androgen deprivation therapy, whichever comes first, assessed up to 36 months. |
| Triglyceride levels | Relationship between triglyceride levels and response to anti-metabolic and anti-cholesterol therapy | From date of randomization until the date of progression or patient/physician desire for androgen deprivation therapy, whichever comes first, assessed up to 36 months. |
| Incidence of adverse events during administration of metformin and atorvastatin to men with prostate cancer. | Assessment of incidence of adverse events from the administration of metformin and atorvastatin to men with prostate cancer. | From date of randomization until the date of progression or patient/physician desire for androgen deprivation therapy, whichever comes first, assessed up to 36 months. |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |