A Study With or Without Metformin to Determine if Metformin Can Prevent Weight Gain and Other Problems (i.e. Diabetes, Increased Cholesterol, Etc.) That Can Arise From the Use of Hormonal Therapy in Combination With Radiation Therapy When Treating Aggressive Localized Prostate Cancer.
Overview[ - collapse ][ - ]
| Purpose | In current clinical practice, an acceptable standard treatment for high risk prostate cancer is radiation therapy in combination with hormone therapy (called Treatment B or Group B in this study). However, despite our best treatments, there is a risk that the prostate cancer may eventually return. As well, the hormonal therapy that is given to treat the prostate cancer is known to cause some harmful effects, with some patients using the hormones gaining weight, developing diabetes, having increased cholesterol levels, having increased blood pressure, and/or heart problems. This study is looking at whether Metformin, a drug that is commonly used to treat diabetes, can prevent patients from developing some of the harmful effects of the hormonal therapy. In treating diabetes, Metformin is known to decrease patients' sugar levels and also prevents patients from gaining weight, decreases their cholesterol levels, decreases the number of heart problems and allows patients to live longer. As a result, the researchers in this study are hopeful that Metformin will also be beneficial for men with prostate cancer on hormonal therapy by preventing them from developing these problems. |
|---|---|
| Condition | Prostatic Neoplasm |
| Intervention | Drug: Metformin Drug: Placebo |
| Phase | Phase 2 |
| Sponsor | AHS Cancer Control Alberta |
| Responsible Party | AHS Cancer Control Alberta |
| ClinicalTrials.gov Identifier | NCT01996696 |
| First Received | November 22, 2013 |
| Last Updated | December 4, 2013 |
| Last verified | December 2013 |
Tracking Information[ + expand ][ + ]
| First Received Date | November 22, 2013 |
|---|---|
| Last Updated Date | December 4, 2013 |
| Start Date | January 2014 |
| Estimated Primary Completion Date | January 2018 |
| Current Primary Outcome Measures | Mean body weight at 12 months of follow-up [Time Frame: 12 months of follow-up] [Designated as safety issue: Yes] |
| Current Secondary Outcome Measures | Prevalence and incidence of Metabolic Syndrome [Time Frame: At 6, 12, 24 and 36 months follow-up] [Designated as safety issue: Yes] |
Descriptive Information[ + expand ][ + ]
| Brief Title | A Study With or Without Metformin to Determine if Metformin Can Prevent Weight Gain and Other Problems (i.e. Diabetes, Increased Cholesterol, Etc.) That Can Arise From the Use of Hormonal Therapy in Combination With Radiation Therapy When Treating Aggressive Localized Prostate Cancer. |
|---|---|
| Official Title | Prevention of Metabolic Syndrome and Increased Weight Using Metformin |
| Brief Summary | In current clinical practice, an acceptable standard treatment for high risk prostate cancer is radiation therapy in combination with hormone therapy (called Treatment B or Group B in this study). However, despite our best treatments, there is a risk that the prostate cancer may eventually return. As well, the hormonal therapy that is given to treat the prostate cancer is known to cause some harmful effects, with some patients using the hormones gaining weight, developing diabetes, having increased cholesterol levels, having increased blood pressure, and/or heart problems. This study is looking at whether Metformin, a drug that is commonly used to treat diabetes, can prevent patients from developing some of the harmful effects of the hormonal therapy. In treating diabetes, Metformin is known to decrease patients' sugar levels and also prevents patients from gaining weight, decreases their cholesterol levels, decreases the number of heart problems and allows patients to live longer. As a result, the researchers in this study are hopeful that Metformin will also be beneficial for men with prostate cancer on hormonal therapy by preventing them from developing these problems. |
| Detailed Description | This study will examine the role of Metformin as a means to prevent increases in weight as well as the prevalence and severity of metabolic syndrome, with their associated morbidity, amongst men with high risk, biopsy confirmed adenocarcinoma of the prostate (PCa) that are planned to receive curative intent therapy with androgen deprivation therapy (ADT) and external beam radiotherapy (EBRT) to the prostate. Males of any age with biopsy confirmed high risk PCa (any T3; and/or Gleason Score ≥ 8.0; and/or PSA ≥ 20 ng/mL), ECOG 0-1, non-diabetic with no evidence of metastatic PCa will with randomized to either: Group A: Metformin 500mg PO TID for 3 years total, with Neoadjuvant and adjuvant ADT for 2-3 years and EBRT of 46 Gy/23# to pelvic lymph nodes; plus prostate boost to 78 Gy/39# OR Group B: Identical placebo TID for 3 years total, with Neoadjuvant and adjuvant ADT for 2-3 years and EBRT of 46 Gy/23# to pelvic lymph nodes; plus prostate boost to 78 Gy/39# A planned sample size of 104 patients will provide 97% power for a 2-tailed α of 0.05 to detect 4 kg difference in weight at 12 months of follow-up. |
| Study Type | Interventional |
| Study Phase | Phase 2 |
| Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment |
| Condition | Prostatic Neoplasm |
| Intervention | Drug: Metformin Other Names:
Identical placebo TID for 3 years |
| Study Arm (s) |
|
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Not yet recruiting |
|---|---|
| Estimated Enrollment | 104 |
| Estimated Completion Date | January 2018 |
| Estimated Primary Completion Date | January 2017 |
| Eligibility Criteria | Inclusion Criteria: 1. Males ≥ 18 years of age 2. Pathologically confirmed adenocarcinoma of the prostate with 1 or more of the following high risk features 1. Any T3 2. Gleason score ≥ 8.0, or 3. PSA ≥ 20 ng/mL 3. Normoglycemic or impaired Fasting Glucose defined as: 1. Fasting Plasma Glucose of ≤ 6.9; or 2. Plasma Glucose level of 11.0 mmol/L 2 hours following a 75 g oral glucose load; or 3. HbA1c of < 6.4% 4. Deemed fit to undergo curative intent external beam radiation therapy with concurrent androgen deprivation therapy by their attending radiation oncologist 5. Accessible for follow-up clinical and laboratory assessments Exclusion Criteria: 1. Patients with evidence (either by imaging or pathology) of distant metastatic spread of their disease 2. PSA ≥ 100 3. Patients that meet ≥ 1 of the Canadian Diabetes Association criteria for the diagnosis of diabetes: 1. Fasting Plasma Glucose of ≥ 7.0 mmol/L; or 2. HBA 1c of 6.5%; or 3. Plasma Glucose level of ≥ 11.1 mmol/L 2 hours following a 75 g oral glucose load; or 4. Random Plasma Glucose level of ≥ 11.1 mmol/L 4. Patient who currently take Metformin or those who have taken Metformin within the past 12 months 5. History of lactic acidosis or conditions that predispose to lactic acidosis including: a. Impaired Renal Function (eGFR < 45); or b. Liver disease, including alcoholic liver disease, as demonstrated by any of the following parameters: i. AST > 1.8x the upper limit of normal ii. ALT > 1.8x the upper limit of normal iii. Alkaline Phosphatase > 2x the upper limit of normal iv. Serum total bilirubin ≥ upper limit of normal c. Alcohol abuse (habitual intake of ≥ 3 alcoholic beverages per day) sufficient to cause hepatic toxicity d. Severe infection 6. Patients with prior bilateral orchiectomy 7. Patients with prior prostatectomy 8. Patients who are unable to provide informed consent 9. Prior history of malignancy (with exception of adequately treated non-melanomatous skin cancer or other solid tumors treated curatively with no evidence of disease for ≥ 5 years). 10. Patients on hormonal therapy for more than 3 months prior to registration in the trial - |
| Gender | Male |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Contact: Nawaid Usmani, MD 780-432-8518 Nawaid.usmani@albertahealthservices.ca |
| Location Countries | Canada |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01996696 |
|---|---|
| Other Study ID Numbers | CCI-Usmani-01 |
| Has Data Monitoring Committee | Yes |
| Information Provided By | AHS Cancer Control Alberta |
| Study Sponsor | AHS Cancer Control Alberta |
| Collaborators | Not Provided |
| Investigators | Principal Investigator: Nawaid Usmani, MD Cross Cancer Institute |
| Verification Date | December 2013 |
Locations[ + expand ][ + ]
| Cross Cancer Institute | Edmonton, Alberta, Canada, T6G 1Z2 Contact: Nawaid Usmani, MD | 780-432-8518 | Nawaid.usmani@albertahealthservices.caNot yet recruiting |
|---|