A study to evaluate multi-parametric MRI imaging in active surveillance cohort for low risk Prostate Cancer

Not Applicable

Active, not recruiting

• Conditions: Prostate Cancer; Cancer - Prostate

• Registration Number: ACTRN12622000080729
• Lead Sponsor: St. Vincent's Private Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-01-21
• Last Update Posted: 31 January 2022

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: Male
• Target Recruitment: 172

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.

Study & Design

• Study Type: Observational
• Study Design: Not specified