Publication

SelectMDx impacts prostate biopsy decision-making in routine clinical practice

Shore N, Hafron J, Langford T et al. Urol Pract 2018. In press.  https://doi.org/10.1016/j.urpr.2018.09.002

 

What was studied?

This US, retrospective, multi-centre study (May 2016-April 2017) evaluated the effect of the SelectMDx test on patient management for men being considered for initial prostate biopsy in community urology practices. The SelectMDx tests were ordered by the treating urologist for patient management (i.e. not as part of a planned or ongoing study), reflecting real-world shared decision making.

 

What were the main outcomes?

Of 418 men, 165 men (39%) had a positive and 253 men (61%) had a negative SelectMDx test result. Biopsy rates were 5 times higher in SelectMDx-positive men (60%) vs. SelectMDx-negative men (12%; P<0.001).

To increase the probability that SelectMDx test results were incorporated into the biopsy decision the investigators looked at men who were biopsied less than 3 months after the SelectMDx test was performed:

  • 71 (43% of total) SelectMDx-positive men were biopsied and 27 cancers were identified including 10 ISUP grade ≥3 cancers
  • 9 (3.6% of total) SelectMDx-negative men were biopsied and 4 cancers were identified, all ISUP grade ≤2.

 

Table. Biopsy rates and prostate cancer detection for patients biopsied <3 months after the SelectMDx test was performed

 

SelectMDx-negative

SelectMDx-positive

Biopsies (% of total N)

9 (3.6%)

71 (43%)

Positive biopsy

4

27

Gleason Score [ISUP grade]

 

  • GS 3+3  [1]

2

8

  • GS 3+4  [2]

2

9

  • GS 4+3  [3]

0

3

  • GS 8       [4]

0

4

  • GS 9-10 [5]

0

3

  

What was concluded?

The SelectMDx test significantly impacts on initial biopsy-decision making in a US community practice setting. Biopsy-rates were 5-fold higher in SelectMDx-positive men vs SelectMDx-negative men, showing that the test provided actionable information for decision making. In the subset of patients biopsied within 3 months of receiving test results, high-grade cancers were found only in the SelectMDx-positive men, and SelectMDx-negative patients were diagnosed with ISUP-grade 2 or lower grade disease. These results provide evidence that SelectMDx can help identify men with high-grade cancer who would benefit from prostate biopsy and subsequent treatment options. Implementation of the SelectMDx test in a routine clinical pathway could also lead to a decrease in potentially unnecessary diagnostic procedures and treatments

How was the study performed?

This multi-centre study involved 5 US community urology practices. It included 418 men who received a SelectMDx test between May 2016 and April 2017 and in whom a possible initial prostate biopsy was being considered.

Editor comment

Again a nice study that shows that implementation of the SelectMDx test in a community urology setting has impact on the amount of biopsies taken (5- fold lower in  SelectMDx negatives) without missing clinical significant (high-grade)prostate cancer.

Photo Dr. Inge van Oort
Dr. Inge van Oort
Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands

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