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. (PREMIUM)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Prevention of Metabolic Syndrome and Increased Weight Using Metformin|
- Mean body weight at 12 months of follow-up [ Time Frame: 12 months of follow-up ] [ Designated as safety issue: Yes ]
- Prevalence and incidence of Metabolic Syndrome [ Time Frame: At 6, 12, 24 and 36 months follow-up ] [ Designated as safety issue: Yes ]
|Study Start Date:||September 2014|
|Estimated Study Completion Date:||September 2018|
|Estimated Primary Completion Date:||September 2017 (Final data collection date for primary outcome measure)|
Metformin 500 mg PO TID for 3 years
Placebo Comparator: Placebo
Identical placebo TID for 3 years
Identical placebo TID for 3 years
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#
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01996696
|Contact: Nawaid Usmani, MD||780-432-8518||Nawaid.firstname.lastname@example.org|
|Cross Cancer Institute||Recruiting|
|Edmonton, Alberta, Canada, T6G 1Z2|
|Contact: Nawaid Usmani, MD 780-432-8518 Nawaid.email@example.com|
|Winnipeg, Manitoba, Canada, R3E 0V9|
|Contact: Julian Kim, MD 204-787-4760 firstname.lastname@example.org|
|Principal Investigator:||Nawaid Usmani, MD||Cross Cancer Institute|