Prospective, multi-centre, observational cohort study of multi-parametric MRI in active surveillance for low risk Prostate Cancer

St. Vincent's Private Hospital0 个研究点目标入组 172 人开始时间: 2022年1月21日最近更新: 2022年1月31日

适应症

试验速览

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•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

•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.

发起方

St. Vincent's Private Hospital