A Randomised Double-Blind Controlled Trial of Metformin and Atorvastatin – with treatment commenced following prostatic biopsy and ceasing just before radical prostatectomy - to guide subsequent patient management

Phase 1

Suspended

• Conditions: Prostate cancer; Cancer - Prostate

• Registration Number: ACTRN12615000571572
• Lead Sponsor: niversity of Queensland Centre for Clinical Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-06-03
• Last Update Posted: 16 October 2023

Recruitment & Eligibility

• Status: Suspended
• Sex: Male
• Target Recruitment: 80

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Response in histology results between initial targeted prostatic biopsy and radical prostatectomy specimen through a change in the Gleason Score of the cancer[ Baseline (shortly after initial screening) and at the time of radical prostatectomy (6-8 weeks after commencement of intervention)];Detectable metabolic changes to ejaculate assessed via molecular and metabolomic profiling with nuclear magnetic resonance (ex-vivo, all patients) [ Initial screening and 6 weeks after commencement of intervention];Findings from ejaculate profiling (Primary Outcome 2) will be mirrored in-vivo by magnetic resonance imaging (MRI) and magnetic resonance spectroscopy (MRS) with a 7 Tesla machine in a small group of randomised patients (selected from each intervention group as part of the randomisation process) [ Just before biopsy and just before prostatectomy ]

Secondary Outcome Measures

Name	Time	Method
Changes in serum PSA (prostate specific antigen) and biochemical/lipid profiles in blood and urine pathology as indirect indicators of metabolic changes[ Initial screening, 6 weeks after commencement of the intervention, 3-4 months post radical prostatectomy];Tolerability of medications will be assessed by questionnaire assessment (International Prostate Symptom Score (IPSS), International Index of Erectile Function (IIEF), Expanded Prostate cancer Index Composite (EPIC), SF-36, Sexual Health Inventory for Men (SHIM), Distress Thermometer, Brief Symptom Inventory (BSI-18)) (composite outcome)[ Initial screening, 6 weeks after commencement of the intervention, 3-4 months post radical prostatectomy]