PCA3, mpMRI, targeted biopsies, and risk for diagnosis of prostate cancer

The degree to which the PCA3 test is a useful tool in assessment of risk for clinically significant prostate cancer prior to biopsy has never, really, been entirely clear. … READ MORE …

The value of the PCA3 test: a multi-center study

The prostate cancer antigen 3 or PCA3 test was initially approved as an aid to the assessment of risk of prostate cancer in men with an elevated PSA level who had already been given at least one prior, negative biopsy. … READ MORE ..

NICE concludes that PCA3, phi tests not clinically useful

The National Institute for Health and Care Excellence (NICE) has issued draft guidance stating that two approved tests for risk of prostate cancer are not clinically useful in England. … READ MORE …

Old and newer tests and risks for prostate cancer; can you avoid inappropriate biopsy?

We now have five approved tests that can (at least in theory) help a man — and his doctors — to decide whether he is at sufficient risk for clinically significant prostate cancer that he should go get a biopsy. But how good are they really? … READ MORE …

What to make of a PCA3 score of ≥ 100

Some studies (e.g., this one by Roobol et al.) have previously indicated that not all men with very high prostate cancer antigen 3 (PCA3) scores are necessarily found to have prostate cancer on biopsy or re-biopsy. … READ MORE …

PCA3 density as a marker for prostate cancer risk?

Regular readers will be aware that a PSA density (i.e., PSA ÷ prostate volume) > 0.15 has been identified and characterized as a risk factor for clinically significant prostate cancer by researchers at Johns Hopkins. … READ MORE …

TMRPSS2-ERG and PCA3 as markers of risk for men entering active surveillance protocols

A new study just published on line in Clinical Cancer Research shows a degree of correlation between the results of tests for PCA3 and the TMRPSS2-ERG biomarker and risk for progressive disease in men on active surveillance. However, this correlation appears to be less than compelling. … READ MORE …

More data on accuracy of the PCA3 test in the real world

The prostate cancer gene 3 or PCA3 test has been approved exclusively as a means to assess the potential value of a repeat biopsy for a man who has already had a negative biopsy but whose PSA values (and/or other indicators) continue to suggest significant risk for prostate cancer. … READ MORE …

FDA approves Gen-Probe PCA3 test (Progensa)

According to a report today on Xconomy.com, the U.S. Food & Drug Administration has approved the Progensa® PCA3 test developed by Gen-Probe. … READ MORE …

FDA Advisory Board to review Gen-Probe’s PCA3 test next year

The possibility of approval of the Progensa® PCA3 test here in the USA any time soon appears to have received a setback. … READ MORE …

Health Canada approves use of Gen-Probe PCA3 test

Apparently Health Canada has approved coverage of the use of Gen-Probe’s PCA3 test (Progensa™) as a diagnostic test ” to verify the need for repeat biopsies in men at risk of getting prostate cancer.” … READ MORE …

“New” urine test combines data from PCA3 and gene fusion to predict prostate cancer risk

There is a lot of media coverage from late yesterday about a “new” urine test for diagnosis of prostate cancer that is being developed by the University of Michigan in combination with San Diego-based Gen-Probe. Whether the actual value of the test can live up to the media coverage is going to take a while to determine. … READ MORE …

A three-marker algorithm for projecting prostate cancer risk, need for biopsy

A new study has suggested that a clinical algorithm that combines data on serum PSA with detection of TMPRSS2:ERG fusion and prostate cancer gene 3 (PCA3) in urine collected after a digital rectal exam (DRE) can predict prostate cancer on subsequent biopsy better than any one of the three potential markers alone. … READ MORE …

The practical clinical value of the PCA3 test

The prostate cancer gene 3 or PCA3 test has been commercially approved in Europe as a test that provides relevant information associated with the need for a prostate biopsy. It is still awaiting approval in the USA. … READ MORE …

PCA3, PSA, and free PSA in prediction of prostate cancer risk

A new study has suggested that, although the PCA3 test is slightly better than the total PSA test in prediction of risk for a positive biopsy finding, it is not necessarily always better than the free PSA test. … READ MORE …