In a nutshell
This phase 2 trial aims to evaluate the benefit of adding metformin (Glucophage) to hormone therapy with bicalutamide (Casodex). The main outcome to be investigated is treatment response. The trial is recruiting in Philadelphia (Pennsylvania), USA.
The details
Obesity and metabolic syndrome (a collection of conditions including increased blood pressure, blood sugar levels, insulin, and cholesterol levels) are common among prostate cancer patients. Having elevated insulin levels in the blood (a hormone that breaks down blood sugar levels) has been associated with poor treatment outcomes.
Metformin is a drug commonly used in the management of type 2 diabetes. Metformin works by suppressing glucose production in the liver and increasing the body's sensitivity to insulin. Previous studies have suggested that metformin may also affect the progression of certain cancers. Adding metformin to hormone therapy such as bicalutamide may be beneficial for obese or overweight prostate cancer patients.
This study will examine the benefit of adding metformin to hormone therapy with bicalutamide compared to bicalutamide alone for obese or overweight prostate cancer patients. Treatment response will be measured with blood tests over a period of 32 weeks.
Who are they looking for?
This study will recruit about 66 overweight or obese men with localized prostate cancer. Participants should have undergone primary therapy with surgery or radiation and show signs of disease progression (based on blood test) after primary therapy. Additional treatment with surgery, radiation, immunotherapy, or chemotherapy is permitted. Previous hormone therapy, however, is only permitted if it has been discontinued at least 1 year before participation. PSA (prostate specific antigen; a protein present in prostate cancer) levels should be less than 30 ng/mL. Full blood counts will be evaluated before study participation.
Participants should not have very low testosterone levels (at castrate levels). Patients cannot take part in the trial if the cancer has spread outside the prostate. Any radiation therapy must be discontinued for at least 6 months before taking part. Participants must not be receiving another investigational within 30 days of the study. Participants must not consume more than 3 alcoholic beverages per day. Participants should not have a history of any heart disease, have an active infection, any other cancers that were active within the last 2 years (with the exception of treated skin cancer), or present with any significant or uncontrolled medical or psychiatric illnesses.
How will it work
Participants will be randomly assigned to either undergo treatment with metformin and bicalutamide or bicalutamide alone. 1 cycle of treatment will last 28 days. There will be 8 cycles in total. The starting dose of metformin starting dose will be 500 mg by oral dose, which will be gradually increased to target dose of 1000 mg. 50 mg of bicalutamide will be administered daily by oral dose at the beginning of cycle 3 to cycle 8.
Treatment response will be measured with blood tests over a period of 32 weeks. The time to disease progression will also be compared between treatment groups. Questionnaires will measure changes in quality of life and side effects.
Clinical trial locations
| Type: | Interventional |
| Participants: | 29 |
| Study ID: | NCT02614859 |
