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Progensa PCA3 test

Prostate cancer (PCa) is one of the most prevalent types of cancer in men, yet it’s also one of the most treatable – if it’s caught early.

The Progensa PCA3 assay is the first urine-based molecular test that can give you the confidence to make better repeat biopsy decisions.

The Progensa PCA3 test:

  • Uses a simple, non-invasive urine specimen collected post-digital rectal exam (DRE).
  • Detects the PCA3 gene highly specific for PCa.
  • Adds useful and actionable clinical information when PSA or DRE is inconclusive.
  • May help reduce the number of unnecessary repeat biopsies.

 

About

Common clinical practices for the characterization and risk assessment of  PCa utilize serum prostate-specific antigen (PSA) and DRE as indications for biopsy.  However, in several high profile studies, the low specificity of serum PSA for PCa (i.e., false positive results) has been shown to lead to unnecessary biopsies and to significant issues of over-detection and over-treatment. Moreover, in about 20 percent of cases, prostate biopsy can miss malignancies, leading physicians to conduct many unnecessary repeat biopsies in an effort to avoid missing cancer. The Progensa PCA3 assay -– an FDA-approved prostate cancer testing solution designed to detect the prostate cancer gene 3 (PCA3), which is known to be highly specific for prostate cancer –- is independent of serum PSA and other commonly used predictive measures.  The additional clinical information provided by the PCA3 assay can assist physicians and patients in making better repeat biopsy decisions by helping balance the fear of missing cancer with the risks and adverse effects associated with the prostate biopsy procedure, some of which can be very serious.  

The Progensa PCA3 assay, an in vitro nucleic acid amplification test, measures the concentration of PCA3 and PSA RNA molecules in male urine specimens. The assay calculates the ratio of PCA3 RNA molecules to PSA RNA molecules to generate a PCA3 score. Studies have shown that because the PCA3 gene is highly specific for prostate cancer, the Progensa PCA3 score predicts the results of repeat biopsies more accurately than traditional serum PSA testing in patients who have had one or more previous negative prostate biopsies. In fact, in the clinical study conducted prior to Hologic submitting a Premarket Approval Application (PMA) to the FDA, the Progensa PCA3 had a negative predictive value of 90%, meaning that a negative Progensa PCA3 assay result predicted a negative prostate biopsy 90% of the time. When evaluated with other risk factors, the Progensa PCA3 assay fills an important unmet clinical need by helping physicians identify which men suspected of having prostate cancer should undergo a repeat prostate biopsy.  

For the most current information on the clinical performance and utility of the Progensa PCA3 assay, please visit www.PCA3.org.* 

*Materials contained on the PCA3.org website below ("Content") are compiled from a variety of sources and are for informational purposes only.  The Content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Reliance on any Content provided on PCA3.org, is solely at your own risk.

Instructions for Use

Urine Specimen Collection and Handling

1. Obtain a first catch, post-digital rectal exam (DRE) urine specimen in a urine collection cup.

Unprocessed urine specimens, if not immediately processed, must be maintained at 2°C to 8°C or kept on ice. The chilled, unprocessed urine specimen must be transferred into the urine specimen transport tube within 4 hours of collection. Do not freeze unprocessed urine specimens.

2. To process urine specimens, tightly cap and invert the unprocessed urine specimens 5 times to re-suspend cells. Remove the cap of the urine specimen transport tube and transfer 2.5 mL of the collected urine into the tube using the disposable transfer pipette provided. The correct volume of urine has been added when the fluid level is between the black fill lines on the urine specimen transport tube label.

          Note: If less than 2.5 mL of urine is available, the specimen must be rejected.

3. Re-cap the urine specimen transport tube tightly and invert the urine specimen 5 times to mix. This is now known as the processed urine specimen.

4. Store and transport processed urine specimens according to instructions provided by the testing laboratory. Processed samples may be shipped under ambient conditions or frozen-shipping arrangements must be made to ensure specimens are received by the testing site within five days of collection. 

 

Prevalence

According to the American Cancer Society (ACS), prostate cancer is the second most common type of cancer found in American men (behind skin cancer), and the second leading cause of cancer death in men (after lung cancer). One in six American men will get prostate cancer during his lifetime, and one in 36 will die from it. The ACS estimates that about 240,000 Americans were newly diagnosed with prostate cancer in 2012, and that approximately 30,000 men died from the disease.