ACTRN12615000571572SuspendedPhase 1
The effectiveness of a combination of Metformin and Atrovastatin compared with each drug alone and placebo in modulating tumour aggressiveness in men with high risk prostate cancer undergoing radical prostatectomy
niversity of Queensland Centre for Clinical Research0 sites80 target enrollmentStarted: June 3, 2015Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Suspended
- Sponsor
- Enrollment
- 80
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Treatment
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 40 Years to 80 Years (—)
- Sex
- Male
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
Investigators
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