None listed
Conditions
Brief summary
The primary purpose of this study is to determine whether Metformin and Atorvastatin (taken alone or together) improve outcomes for men with prostate cancer in terms of the aggressiveness and the biology of their cancer Who is it for? You may be eligible to join this study if you are aged 40 to 80 years, have a PI-RADSv2 (Prostate Imaging-Reporting and Data System) score of 4 or 5 and proceed to prostate biopsy with an intention of having a prostatectomy for confirmed high-risk prostate cancer. Study details Metformin is a medication commonly used in the treatment of Type 2 Diabetes to lower blood sugar levels and Atorvastatin is a common cholesterol lowering medication. Previous research has found that people who take these Metformin are less likely to have prostate cancer and those who take Atorvastatin are more likely to have less dangerous prostate cancers. Participants in this study will be randomly allocated (by chance) to one of four groups. The four groups will be divided as: 1) Placebo; 2) Metformin; 3) Atorvastatin; and 4) Metformin and Atorvastatin. You will have to take oral capsules three times a day for 6 weeks and all parties will be blinded regarding patient treatment allocation. Patient outcomes will then be assessed through blood, urine and tissue samples provided before the treatment starts and 6-8 weeks after as well as through medical imaging for some patients. It is hoped that the findings of this pilot trial will serve to help other men after they have had diagnostic prostatic biopsies showing prostate cancer, through providing evidence for a treatment that reduces the aggressiveness of their cancer, although this will need to be established in larger studies.
Interventions
Group 1
Participants randomised to Group 1 will receive Metformin 500mg twice a day and placebo once a day as oral capsules from randomisation until 6 weeks later when they give their second blood and urine samples for the trial just prior to radical prostatectomy.
Group 2
Participants randomised to Group 2 will receive Atorvastatin 20mg once a day and placebo twice a day as oral capsules from randomisation until 6 weeks later when they give their second blood and urine samples for the trial ju
Group 1 Participants randomised to Group 1 will receive Metformin 500mg twice a day and placebo once a day as oral capsules from randomisation until 6 weeks later when they give their second blood and urine samples for the trial just prior to radical prostatectomy. Group 2 Participants randomised to Group 2 will receive Atorvastatin 20mg once a day and placebo twice a day as oral capsules from randomisation until 6 weeks later when they give their second blood and urine samples for the trial just prior to radical prostatectomy. Group 3 Participants randomised to Group 3 will receive Metformin 500mg twice a day + Atorvastatin 20mg once a day as oral capsules from randomisation until 6 later when they give their second blood and urine samples for the trial just prior to radical prostatectomy. Intervention adherence will be monitored through drug tablet return at the end of the intervention.
Sponsors
University of Queensland Centre for Clinical Research
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
Male
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Patients will be eligible for the trial if they are adult men aged 40 to 80 years who have a PI-RADSv2 (Prostate Imaging-Reporting and Data System) score of 4 or 5 and proceed to prostate biopsy with an intention of having a prostatectomy for confirmed high-risk prostate cancer
Exclusion criteria
Participants will be ineligible for the trial if they: - have been taking any lipid (fats) or cholesterol-lowering medication or blood-glucose (sugar level)-lowering drugs - have experienced any unwanted effects with lipid or glucose-lowering drugs previously - have been considered by their urologist to be unsuitable for the research programme or involvement in the study is not consistent with the patient’s best interests - are taking medications that could cross-react with medications used in the trial
Outcome results
None listed