Publication

Initial clinical utility assessment of a two-gene mRNA PCR liquid biopsy test for early detection of significant prostate cancer in a Dutch peripheral hospital

Using SelectMDx to identify men for prostate biopsy may reduce healthcare costs and improve health-related quality of life

 

Minnee P et al. Presented at the Global Congress of Prostate Cancer (PROSCA) 2017 abstract 42

 

What was studied?

This study compared the use of SelectMDx with the ERSPC risk calculator (ERSPC-RC) in a cohort of biopsy-naïve men and men with a history of one or more prior negative biopsies.

(ERSPC: European Randomized study of Screening for Prostate Cancer)

 

What were the main outcomes?

In men with one or more prior negative biopsies, both SelectMDx and ERSPC-RC indicated a need for repeat biopsy in 5 men (Table).

In 15 men, the ERSPC-RC indicated no need for repeat biopsy, however, in this group the SelectMDx test indicated a high risk for finding clinically significant cancer and a need for biopsy (Table). A biopsy was performed in 6 of the 15 men. In 3 men, prostate cancer was detected (2 Gleason score 7 and 1 Gleason score 6).

 

Table. Outcome of SelectMDx and ERSPC-RC for predicting high-grade prostate cancer in men with one or more prior negative biopsies

 

ERSPC-RC +

ERSPC-RC -

Total

SelectMDx +

11

1

12

SelectMDx -

5

9

14

Total

16

10

26

ERSPC-RC: European Randomized study of Screening for Prostate Cancer risk calculator

 

What was concluded?

This preliminary study in a small population of men with one or more prior negative biopsies showed that SelectMDx detected cases of clinically significant prostate cancer that would have been missed by the ERSPC-RC. Although further prospective, large-size, well-designed studies are needed, this suggests that SelecMDx testing leads to an improvement in diagnosis of prostate cancer.

 

How was the study performed?

This prospective cohort study in a Dutch peripheral hospital included 60 men; 26 were biopsy-naïve and 34 had one or more prior biopsies. Urine was collected after a DRE for the SelectMDx test. In addition, the ERSPC-RC (including PSA, biopsy history, DRE, TRUS outcome and prostate volume) was performed in all men.

Editor comment

SelectMDx will play a major role in the identification of men who should receive a prostate biopsy. SelectMDx outperforms clinical tools such as the ERSPC risk calculator in the identification of patients at increased risk of harbouring clinically significant prostate cancer. Further studies are needed to confirm these findings on a larger scale.

Photo Dr. Giorgio Gandaglia
Dr. Giorgio Gandaglia
Vita-Salute San Raffaele University, Milan, Italy

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