New Urine Test for Prostate Cancer

[Nelson Vergel]

The recent development of an 18-gene urine test, known as MyProstateScore 2.0 (MPS2), represents a significant advancement in the detection of high-grade prostate cancer. This test has demonstrated higher diagnostic accuracy compared to existing biomarker tests and has the potential to reduce unnecessary biopsies and other invasive procedures.

### Key Features and Findings

1. **Gene Markers**:
- The MPS2 test incorporates 18 genes, including 17 markers uniquely overexpressed by high-grade prostate cancers (Grade Group 2 or higher) and one reference gene, KLK3. These markers include high-grade cancer-specific genes (APOC1, B3GNT6, NKAIN1, SCHLAP1), cancer-specific genes (PCGEM1, SPON2, TRGV9, PCA3, OR51E2, CAMKK2, TFF3, PCAT14, TMSB15A), and curated markers (HOXC6, ERG, TMPRSS2:ERG, KLK4)[1][2][3].

2. **Diagnostic Accuracy**:
- The MPS2 test has shown an area under the receiver operating characteristic curve (AUC) of 0.81 to 0.82, significantly higher than other tests such as PSA alone (0.60), the Prostate Cancer Prevention Trial risk calculator (0.66), and the Prostate Health Index (0.77)[1][5][11].
- The test demonstrated a negative predictive value (NPV) of 95% to 99% for cancers of Grade Group 2 or higher and 99% for Grade Group 3 or higher, indicating a high level of accuracy in ruling out aggressive cancers[3][11].

3. **Reduction in Unnecessary Biopsies**:
- The use of MPS2 could reduce unnecessary biopsies by 35% to 42% in the initial biopsy population and by 46% to 51% in the repeat biopsy population, compared to 15% to 30% reductions with other biomarker tests[1][3][11].

4. **Clinical Implications**:
- The test is particularly useful for patients with elevated PSA levels, helping to distinguish between aggressive cancers that require immediate treatment and slow-growing cancers that can be monitored[4][6][10].
- It provides a non-invasive alternative to more burdensome tests like MRI and biopsy, which can be invasive and carry risks of complications[4][6][8].

5. **Validation and Study Cohorts**:
- The MPS2 test was validated using a cohort of 743 men with a median age of 62 years and a median PSA level of 5.6 ng/mL. The validation study confirmed the test's effectiveness in accurately detecting high-grade prostate cancers[1][2][5].

6. **Limitations and Future Research**:
- One limitation noted is the underrepresentation of non-White ethnic groups in the validation cohort, with only 12.8% of participants identifying as Black. Further studies are being conducted to ensure the test's applicability across diverse populations[10][12].

### Conclusion

The MyProstateScore 2.0 (MPS2) test represents a promising tool in the early detection and management of high-grade prostate cancer. Its high diagnostic accuracy and ability to reduce unnecessary biopsies make it a valuable addition to current prostate cancer screening protocols. Further research and validation in more diverse populations will be essential to fully realize its potential benefits.

Sources
[1] Novel 18-Gene Urine Test Better Detects Clinically Significant ... Novel 18-Gene Urine Test Better Detects Clinically Significant Prostate Cancer
[2] Development and Validation of an 18-Gene Urine Test for High ... Development and Validation of an 18-Gene Urine Test for High-Grade Prostate Cancer
[3] Urine Test Accurately Detected High-Grade Prostate Cancer Urine Test Accurately Detected High-Grade Prostate Cancer
[4] Urine test identifies high-risk prostate cancers Urine test identifies high-risk prostate cancers
[5] New Prostate Cancer Urine Test Produces Greater Diagnostic ... New Prostate Cancer Urine Test Produces Greater Diagnostic Accuracy vs Existing Tests in High-Grade Prostate Cancer
[6] New urine test has higher diagnostic accuracy for prostate cancer New urine test has higher diagnostic accuracy for prostate cancer - VUMC News
[7] The Cost Implications of Prostate Cancer Screening in the Medicare ... The Cost Implications of Prostate Cancer Screening in the Medicare Population
[8] New urine test may help some men with elevated PSA avoid biopsy New urine test may help some men with elevated PSA avoid biopsy - Harvard Health
[9] Development and Validation of an 18-Gene Urine Test for High ... Development and Validation of an 18-Gene Urine Test for High-Grade Prostate Cancer - PubMed
[10] An Improved Prostate Cancer Biomarker Test May Help Men Avoid ... An Improved Prostate Cancer Biomarker Test May Help Men Avoid Unnecessary Biopsy
[11] 18-gene urine test may reduce unnecessary prostate biopsies 18-gene urine test may reduce unnecessary prostate biopsies
[12] New Urine Test for Prostate Cancer May Help Reduce Unnecessary ... Prostate Cancer: New Urine Test May Help Reduce Unnecessary Biopsies
[13] New urine-based test detects high grade prostate cancer, helping ... New urine-based test detects high grade prostate cancer, helping men avoid unnecessary biopsies
[14] New urine-based test detects high grade prostate cancer, helping ... New urine-based test detects high grade prostate cancer, helping men avoid unnecessary biopsies
[15] 18-Gene Urine Test for Prostate Cancer to Help Avoid Unnecessary ... 18-Gene Urine Test for Prostate Cancer to Help Avoid Unnecessary Biopsies
[16] Multigene Urine Test for High-Grade Prostate Cancer Validated in ... Multigene Urine Test for High-Grade Prostate Cancer Validated in Clinical Study
[17] Urine test shown to help as many as half of patients with Gleason 3+ ... https://howardwolinsky.substack.com/p/urine-test-shown-to-help-as-many
[18] Development and Validation of an 18-Gene Urine Test for High ... Development and Validation of an 18-Gene Urine Test for High-Grade Prostate Cancer

 

[Nelson Vergel]

Urine Test Could Prevent Unnecessary Prostate Biopsies

Quantitative PCR analysis of 54 candidate genes was performed on urine samples that had been prospectively collected before biopsy.

ma1.mdedge.com

 

[tropicaldaze1950]

Nelson, about six months ago, with my PSA not budging from 4.8, and concerned, I discussed biopsies with my urologist. He told me there was an FDA approved urine test for men with a PSA of 4 or higher that looks for a specific substance which is secreted by cancer cells. Being on Medicare, I asked if it was covered and he said it was. He put in the order and the test package was shipped from the company in Boston. Packed the urine sample with the ice pack and it was FedEx'ed back. The test results were negative. We suspect inflammation is driving up the PSA, not BPH, which is mild. When I see him in a couple of months, and if my number is still elevated, I'll ask about a course of antibiotics.
[IMG alt="Bio-Techne Exosome logo"]https://www.exosomedx.com/themes/custom/biotechne/logo.svg[/IMG]

 

[Deleted member 16042]

I used Select MDX a couple times 3-5 years ago, was helpful in decision making.

Is this MPS2 significantly different/better?

 

[Nelson Vergel]

Asked my AI tool:

Comparison of Prostate Cancer Tests: SelectMDx vs. MyProstateScore 2.0 (MPS2)​

Overview​

SelectMDx and MyProstateScore 2.0 (MPS2) are both urine-based tests designed to improve the accuracy of prostate cancer diagnosis and reduce unnecessary biopsies. Here is a detailed comparison of the two tests based on the provided sources.

SelectMDx​

Mechanism and Markers:

• SelectMDx measures the expression levels of two mRNA biomarkers, HOXC6 and DLX1, which are associated with aggressive prostate cancer.
• The test combines these biomarkers with clinical risk factors such as age, PSA level, prostate volume, and DRE results to generate a personalized risk score.

Clinical Utility:

• SelectMDx is used to determine the risk of aggressive prostate cancer and whether a biopsy is necessary.
• It has a sensitivity of 76.9% and a negative predictive value (NPV) of 82.09% for significant prostate cancer (Gleason score ≥7).
• The test is included in the National Comprehensive Cancer Network (NCCN) guidelines for prostate cancer early detection.

Validation and Performance:

• Studies have shown that SelectMDx can reduce unnecessary biopsies by approximately 40.72%.
• It is particularly useful in patients with PSA levels between 3 and 10 ng/mL and can be combined with multiparametric MRI (mpMRI) to improve diagnostic accuracy.

Limitations:

• The test's performance can vary based on patient demographics and clinical settings.
• It has not been reviewed by the U.S. Food and Drug Administration (FDA).

MyProstateScore 2.0 (MPS2)​

Mechanism and Markers:

• MPS2 measures a panel of 18 genetic markers, including the original MPS markers (PCA3 and TMPRSS2:ERG) and 16 additional biomarkers associated with high-grade prostate cancer.
• The test combines these genetic markers with clinical factors such as age, race, and family history to provide a comprehensive risk assessment.

Clinical Utility:

• MPS2 is designed to identify clinically significant prostate cancers (Grade Group 2 or higher) and help avoid unnecessary biopsies.
• It has shown a sensitivity of 95% for Grade Group 2 cancers and 99% for Grade Group 3 and above, with a high NPV.

Validation and Performance:

• MPS2 has been validated in multiple studies, showing it can reduce unnecessary biopsies by up to 51%.
• The test has been shown to outperform other biomarker tests in accurately identifying high-grade cancers.

Limitations:

• The validation cohort included a small percentage of African American men, necessitating further studies in more diverse populations.
• The test is pending FDA review for public marketing.

Key Differences​

1. Biomarkers:
   • SelectMDx uses two biomarkers (HOXC6 and DLX1) combined with clinical factors.
   • MPS2 uses a more extensive panel of 18 genetic markers, providing a broader genetic assessment.
2. Sensitivity and NPV:
   • SelectMDx has a sensitivity of 76.9% and an NPV of 82.09% for significant prostate cancer.
   • MPS2 has a higher sensitivity (95% for GG2 and 99% for GG3 and above) and a higher NPV, making it more reliable in ruling out high-grade cancers.
3. Clinical Guidelines:
   • Both tests are included in the NCCN guidelines, but MPS2 is noted for its higher diagnostic accuracy and broader genetic assessment.
4. Validation and Use:
   • SelectMDx has been validated in various clinical settings and is widely used in Europe and the U.S.
   • MPS2 has shown superior performance in recent studies and is expected to be included in more clinical guidelines pending further validation and FDA approval.

Conclusion​

Both SelectMDx and MPS2 offer significant improvements over traditional PSA testing by providing more accurate risk assessments for prostate cancer. However, MPS2 appears to have a higher diagnostic accuracy and a broader genetic basis, making it potentially more effective in identifying high-grade prostate cancers and reducing unnecessary biopsies. Further studies and FDA approval will solidify its place in clinical practice.



Citations:
[1] An Improved Prostate Cancer Biomarker Test May Help Men Avoid Unnecessary Biopsy
[2] Select mdx for Patients - mdxhealth
[3] Next-Generation Screening for Prostate Cancer | Department of Urology
[4] Urine test identifies high-risk prostate cancers
[5] Tests - mdxhealth
[6] MyProstateScore 2.0
[7] Prospective study of diagnostic accuracy in the detection of high-grade prostate cancer in biopsy-naïve patients with clinical suspicion of prostate cancer who underwent the Select MDx test - PubMed
[8] Clinical use of the SelectMDx urinary-biomarker test with or without mpMRI in prostate cancer diagnosis: a prospective, multicenter study in biopsy-naïve men - Prostate Cancer and Prostatic Diseases
[9] Provide Individualized Prostate Cancer Risk Assessment For Your Patients | MyProstateScore 2.0 | Lynx Dx
[10] Select mdx for Physicians - mdxhealth
[11] Clinical use of the mRNA urinary biomarker SelectMDx test for prostate cancer
[12] New urine-based test detects high-grade prostate cancer, helping men avoid unnecessary biopsies
[13] The SelectMDx test: genomic prostate cancer testing without a biopsy? - Santis Health
[14] Prostate Cancer Detection: SelectMDx - University Urology Associates
[15] MyProstateScore 2.0 | Prostate Cancer Risk Assessment | Lynx Dx
[16] Multigene Urine Test for High-Grade Prostate Cancer Validated in Clinical Study
[17] https://www.pcmarkers.com/selectmdx-results
[18] https://www.health.harvard.edu/blog...n-with-elevated-psa-avoid-biopsy-202405063038
[19] https://www.diagnosticsworldnews.co...way-for-new-and-improved-prostate-cancer-test
[20] https://ecancer.org/en/news/24601-new-urine-test-has-higher-diagnostic-accuracy-for-prostate-cancer

 

[Nelson Vergel]

The test results were negative. We suspect inflammation is driving up the PSA, not BPH, which is mild.

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