Today, many physicians follow a three-stage approach for diagnosing aggressive prostate cancer.

1. Initial Screening for Prostate Cancer

Screening age-appropriate men for prostate cancer usually begins with a Prostate Specific Antigen (PSA) blood test. Considerations when selecting men for screening include age, family history, race, genetic probability, and other findings that may indicate a higher or lower probability of prostate cancer.

An estimated 20 million PSA tests are performed annually in the U.S., and while PSA is an effective initial screening test for prostate cancer, it poses significant diagnostic challenges.

PSA test results may be abnormal for a number of reasons not related to prostate cancer, including prostate infection, inflammation, or benign prostatic hyperplasia (BPH), which is a common condition found in older men. As a result, many prostate biopsies performed due to an elevated PSA find no prostate cancer. In addition, PSA is a poor differentiator between indolent prostate cancer, which does not require further treatment, and aggressive, high-grade cancer, which requires early detection to prevent metastasis and mortality.

Because of PSA’s lack of specificity for differentiating aggressive prostate cancer from indolent or no cancer, many men undergo prostate biopsies that could be avoided. Of the close to one million prostate biopsies performed in the U.S. annually, approximately 75% will result in diagnosing indolent prostate cancer or no cancer at all.

2. Testing to Detect Probability of Aggressive Prostate Cancer

The goal for physicians is to diagnose aggressive prostate cancer as early as possible, when treatment is most effective. The 4Kscore® Test is an FDA-approved blood test developed to improve patient care by providing a man’s probability for aggressive prostate cancer after an abnormal PSA or other screening result and prior to making a shared decision. The 4Kscore® Test provides physicians and patients with highly accurate, actionable information to make better-informed clinical decisions.

The 4Kscore® Test:

• Is FDA approved and is indicated for use with other patient information as an aid in the decision for prostate biopsy in men 45 years of age and older who have an abnormal age-specific total PSA and/or abnormal digital rectal exam (DRE). The 4Kscore® Test is intended to aid in detection of aggressive prostate cancer (Gleason score ≥7/Gleason Grade Group ≥2) in those for whom a biopsy would be recommended by a urologist based on current standards of care before consideration of The 4Kscore Test
• Is used as a follow-up test after an abnormal PSA and has excellent sensitivity and Negative Predictive Value (NPV) for aggressive prostate cancer, demonstrated in large prospective U.S.–based trials
• Has been shown to stratify long-term probability (up to 20 years after the test result) for developing metastatic cancer or dying from prostate cancer
• Provides important, clear information for shared decision-making between patient and physician about the individualized probability of aggressive prostate cancer prior to making a prostate biopsy decision
• Reduces prostate biopsies in low-probability men, along with overtreatment of indolent cancer
• Identifies high-probability men for early evaluation, potentially preventing spread of the cancer outside the prostate
• If The 4Kscore® Test indicates low probability for finding aggressive prostate cancer, the physician and patient may decide to forego a prostate biopsy after evaluating all pertinent clinical information. If The 4Kscore® Test indicates elevated probability for aggressive prostate cancer, further diagnostic testing should be considered, including a prostate biopsy

3. The Prostate Biopsy

A conclusive diagnosis of aggressive prostate cancer is made through a prostate biopsy, which in most cases examines 10 or more prostate tissue “cores” usually taken through the rectum or perineum. Prostate biopsies are guided by an ultrasound, MRI, or a combination of these modalities. Tissue specimens obtained are reviewed by a pathologist to determine if prostate cancer is present and then to grade the cancer with a Gleason score. A Gleason 6 or lower is generally considered low grade, while Gleason 7-10 are high-grade cancers.

The prostate biopsy procedure has its limitations. Pathologists can only diagnose and grade prostate cancer if cancer is present in the biopsy specimen, which samples a small part of the prostate. Therefore, if cancer is present in an area of the prostate that is not sampled by the biopsy, or if the biopsy misses the aggressive sections of the cancer, then the report will not truly reflect the tumor aggressiveness. This results in instances of undiagnosed or “undergraded” prostate cancer. Accurate identification of prostate cancer and tumor aggressiveness is one of the greatest challenges in prostate cancer diagnosis today.

Like any invasive medical procedure, there are probabilities associated with a prostate biopsy. The potential for pain, bleeding, sepsis, and hospitalization can all occur after a prostate biopsy. Although most serious complications are rare, they occur to the detriment of the patient’s health and comfort. Therefore, it is ideal to perform a biopsy only when the benefits clearly outweigh the probabilities.

It is essential that physicians find diagnostic tools that better target candidates for a prostate biopsy by improving specificity for aggressive prostate cancer and reducing the number of avoidable biopsies in low-probability men. The 4Kscore® Test fills the diagnostic gap between PSA as a screening test and biopsy as an invasive procedure with associated complications and cost. By providing the probability of aggressive prostate cancer in men with an elevated PSA, it reduces avoidable prostate biopsies in low-probability men while identifying high-probability men for further evaluation.

 

Reference

1. American Cancer Society. https://www.cancer.org/cancer/prostate-cancer/about/key-statistics.html