Early Detection Research Network

Evaluating SelectMDx for the prediction of high-grade prostate cancer in men with low-grade prostate cancer on active surveillance in the Canary Prostate Active Surveillance Study (PASS)

MDx
424

No coordinating investigator defined.

No design specified.
Proteomics
[u'Prostate and Urologic Cancers Research Group']
4

The need for repeated biopsy is a major downside of active surveillance, and can lead to patients opting for definitive treatment or, conversely, declining to continue monitoring their disease. The ability to predict the result of active surveillance biopsy, and therefore decrease the incidence of biopsy, could therefore dramatically increase the acceptability of active surveillance.

1) To determine whether the SelectMDx, collected on or shortly before the first active surveillance biopsy, can predict high-grade cancer on the first active surveillance biopsy. The performance of the SelectMDx markers will be evaluated a) on their own, b) in their ability to improve prediction using routine clinical factors, and c) compared to the known urine marker PCA3. For Study Objective 1, a minimum of 690 urine samples that occur on or shortly before the first active surveillance biopsy will be used. 2) To determine whether the SelectMDx, collected after diagnosis and before the first surveillance biopsy, can predict men who will not progress or reclassify within four years from diagnosis. The performance of the SelectMDx markers will be evaluated a) on their own, b) in their ability to improve prediction using routine clinical factors, and c) compared to the known urine marker PCA3. For Study Objective 1, a minimum of 690 urine samples that occur on or shortly before the first active surveillance biopsy will be used. 3) To determine if the SelectMDx significantly changes over time, and to assess the amount of within-participant versus between-participant variability in the SelectMDx. If changes are detected, then modeling for associations with clinical endpoints will be performed. For Study Objective 3, a minimum of 1500 serial specimens collected at 6 month intervals after the first active surveillance biopsy will be used. These serial urine specimens will be selected based on a random sample of 300 participants, with a median of 5 urine samples each. We expect to have approximately 400-500 samples from Study Objectives 1 & 2 above that will overlap with Study Objective 3.

There are currently no biomarkers annotated for this protocol.

No datasets are currently associated with this protocol.