None listed
Conditions
Brief summary
The purpose of this study is to assess the accuracy and utility of MRI imaging in patients who are in active surveillance. Who is it for? You may be eligible for this study if you are an adult male, who has been diagnosed with low risk prostate cancer and your urologist has put you in active surveillance. All participants will be asked to undertake an MRI scan, have their blood test for PSA test result and have the urologist conduct a direct rectal exam within (6 months prior to your biopsy, 1 yr, 2 yrs and 3yrs). Follow-up will be as per standard of care with the urologist
Interventions
Multi-parametric MRI scans will be performed as per standard of care for patients on active surveillance and assessed as per this protocol at Baseline, 1 year, 2 years and 3 years including follow-up up to 7 years consistent with the highest standards of prostate MRI:
• 3-Tesla magnet field strength
• 32-channel system with 14-channel spine coil and 18-channel pelvic phased array coil arrangement
• T1-weighted gradient spine echo sequence to identify biopsy haemorrhage artifact
• T2-weighted, hi
Multi-parametric MRI scans will be performed as per standard of care for patients on active surveillance and assessed as per this protocol at Baseline, 1 year, 2 years and 3 years including follow-up up to 7 years consistent with the highest standards of prostate MRI: • 3-Tesla magnet field strength • 32-channel system with 14-channel spine coil and 18-channel pelvic phased array coil arrangement • T1-weighted gradient spine echo sequence to identify biopsy haemorrhage artifact • T2-weighted, high spatial resolution, anatomical imaging to identify and precisely localise areas of suspicion, and direct MRI-guided biopsy where performed; • T2-weighted imaging in 3 planes with sagittal, coronal, axial and TSE images; • Diffusion-Weighted Imaging with software derived Apparent Diffusion Co-efficient (ADC) quantitative analysis maps, and multiple B-values (0, 400, 800, 1400); • Dynamic Contrast Enhanced imaging (DCE) with automatically-delivered IV gadolinium DTPA bolus 10ml at 3ml/ second followed by rapid sequences with temporal resolution of between 4-7 seconds between scans; • Detailed quantitative analysis of DCEI imaging using K-trans colour maps and curve analysis according to PIRADS DCEI analytic guidelines; • No use of Endo-rectal coils or MR Spectroscopy as per current guidelines • Dedicated MRI physicists present for all scans to optimise protocols • Approximate scan time 30minutes.
Sponsors
St. Vincent's Private Hospital
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Selection criteria: Men over 18years with a life expectancy of at least 10-15 years, choosing active surveillance and meeting low risk criteria. Low risk criteria: men meeting all of the following criteria at baseline: • PSA < 15 • DRE less than or equal to T2a • Gleason less than or equal to 7 with no >5% grade 4 in any core • Less than or equal to 33% of cores positive • Less than or equal to 2 cores with any Gleason 4 • Less than or equal to 8mm cancer on all positive cores
Exclusion criteria
• Women • Age under 18yo • Not meeting low risk criteria (PSA < 15, DRE less than or equal to T2a, Gleason less than or equal to 7 with no >5% grade 4 in any core, less than or equal to 33% of cores positive, less than or equal to 2 cores with any Gleason 4, less than or equal to8mm cancer on all positive cores) • Inadequate baseline diagnostic biopsy using < 12 cores • Inadequate baseline mpMRI not performed at a study location • Not willing to undergo all MRIs & biopsies for entire 3-yr study period. • Contra-indication to MRI (kidney disease eGFR < 40, past gadolinium reaction, non-conforming medical device, metallic foreign bodies, severe anxiety/ claustrophobia). • Those at high risk of burden in research or the inability to provide informed consent, such as mentally ill, intellectually disabled or those highly dependent on medical care.
Outcome results
None listed