None listed
Conditions
Brief summary
The primary purpose of this study is to determine the effect of metformin on certain growth factors that drive progression of prostate cancer. Who is it for? You may be eligible to join this study if you are aged 50 to 80 years, with histologically confirmed prostate cancer of early or locally advanced stage, or metastatic prostate cancer with bone involvement only and have been on stable treatment with androgen deprivation therapy (ADT) in the form of a GnRH agonist for more than 6 months. Study details: Metformin is a commonly used medication for the treatment of type 2 diabetes. We have early evidence that the use of metformin may slow down the growth of prostate cancer cells. However, the exact mechanism remains unknown. In this study participants will be randomly allocated (by chance) to start with either metformin or placebo treatment. Metformin or placebo tablets will be given twice daily over 6 weeks each. You will not know which tablet you are taking until after the trial. Blood samples will be taken at baseline and 6 and 12 weeks in order to assess how metfromin affects levels and activity of growth factors involved in prostate cancer progression.
Interventions
Metformin treatment over 6 weeks; oral tablets, dose - 500 mg twice daily for the first week, followed by 1000 mg twice daily from the second week for 5 weeks. Adherence monitored by empty tablet packet return. No washout between metformin and placebo, as study visits will be at baseline and at the end of each treatment.
Sponsors
Western Sydney Local Health District
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)
Eligibility
Sex/Gender
Male
Age
50 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
(1) Age 50 to 80 years (2) ECOG equal or lower than 1 (3) Histologically confirmed prostate cancer of early or locally advanced stage, metastatic prostate cancer with bone involvement only (4) Stable treatment with ADT in the form of a GnRH agonist for more than 6 months (5) Able to understand and the willingness to sign a written informed consent document
Exclusion criteria
(1) Visceral metastases (2) Castrate-resistant prostate cancer (PSA progression defined as at least 3 PSA rises, measured on three successive occasions more than 1 week apart after hormonal treatment) (3) History of confirmed type 1 or type 2 diabetes mellitus (4) Current or prior use of metformin or other diabetes mellitus treatment within the last year (5) Known hypersensitivity or allergy to metformin or any of its excipients (6) Hypothalamic or pituitary disorders (7) Other forms of malignancies excluding prostate cancer (8) Renal (eGFR < 60mL/min/1.73m2) or hepatic impairment (bilirubin > 1.5 x upper limit normal, ALT and ALP > 2.5x upper limit normal) (9) History of lactic acidosis (10) Cardiac or respiratory insufficiency, alcohol abuse, severe infections that are likely to increase the risk of lactic acidosis (11) Any medications known to cause interference with the endocrine system (excluding ADT) (12) Medical or psychiatric conditions that compromise the patient’s ability to give informed consent
Outcome results
None listed