MyProstateScore

Wei et al. J Clin Oncol. 2014;32:4066-4072

Urinary PCA3 test improves detection of prostate cancer

- 859 patients prospectively enrolled at 11 centers as part of a National Cancer Institute validation study

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- Urinary samples were collected for PCA3 measurement prior to prostate biopsy

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- Addition of PCA3 score to risk assessment with clinical variables (i.e. PCPT risk calculator) significantly improved detection of cancer and high-grade cancer

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- This finding was true for patients undergoing t heir first biopsy (AUC for high-grade cancer; 0.78) and for patients who had previosly undergone a negative biopsy (AUC for high-grade cancer; 0.79)

Leyten et al. Eur Urol. 2014;65:534-542.

Urinary T2:ERG measurement improves detection of prostate cancer and high-grade cancer

-443 men prospectively enrolled at six centers

-Urinary samples were collected for PCA3 and T2:ERG measurement prior to prostate biopsy

-Addition of urinary PCA3 and T2:ERG measures to a clinical risk calculator each significantly improved prediction of prostate cancer (AUC: 0.83 for PCA3, 0.84 for T2:ERG)

-Addition of urinary T2:ERG measures further improved detection of high-grade cancer (AUC: 0.84)

-Combined use of urinary PCA3 and T2:ERG would have allowed 35% of patients to avoid prostate biopsy

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Sanda et al. JAMA Oncol. 2017;3:1085-1093.

Combined use of urinary PCA3 and T2:ERG testing is sensitive for aggressive cancer, avoids unnecessary biopsies, and provides healthcare cost savings

-1077 patients underwent urinary PCA3 and T2:ERG testing prior to initial prostate biopsy.

-In the validation cohort (n=561), addition of PCA3 and T2:ERG scores nearly doubled testing specificity for high-grade cancer, from 17% with PSA alone to 33% with PSA, PCA3, and T2:ERG. 

-Sensitivity of the combined testing approach was 93% for high-grade cancer, and the AUC was 0.81.

-Use of combined PCA3 and T2:ERG testing would have avoided 42% of unnecessary prostate biopsies (those that are negative or detect low-grade cancer); diagnosis would have been delayed in only 7% of high-grade cancers. 

-Compared to biopsying all men with abnormal PSA, use of urinary PCA3 and T2:ERG was estimated to save between $1200 and $2100 per patient.

Tomlins et al. Eur Urol. 2016;70:45–53.

Combining urinary PCA3 and T2:ERG with serum PSA provides highly accurate prediction of high-grade cancer: the MyProstateScore test

-Adding urinary PCA3 and T2:ERG scores to serum PSA, the MyProstateScore test was developed for detection of high-grade cancer in 711 patients.

-MPS improved high-grade cancer detection relative to serum PSA alone (AUC: 0.77 vs. 0.65) and when combined with clinical risk factors (AUC 0.78 vs. 0.71).

-MPS improved high-grade cancer detection in all populations with sufficient data (>50 patients) for testing: initial biopsy, repeat biopsy, normal rectal examination, suspicious rectal examination, and various PSA levels (< 3, 3-10, >10 ng/ml). 

-Use of MPS would have avoided prostate biopsy in nearly a quarter of patients, while delaying detection of only 2.7% of high-grade cancers.

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