Prostate Cancer

How the Prostate Health Index (phi) Helps Answer:
“To Biopsy or Not To Biopsy”
Now physicians can provide diagnostic clarity to patients at risk for prostate cancer

Estimated Reading Time: 4 minutes

Prostate cancer affects approximately 11.6% of men during their lifetime.¹ Early detection can lead to better outcomes. However, for some men, one of the most common detection methods — prostate biopsy — may offer more risk than benefit.

The Impact of Prostate Cancer in the United States

Infographic 1 in 9 men in the U.S. will be diagnosed with prostate cancer with 70% higher incidence in African American males.

Figure 1. Impacts and outcomes for prostate cancer diagnosis

How Prevalent is Prostate Cancer?
Prostate cancer is one of the leading causes of cancer death for men worldwide

In the U.S., an estimated 174,000 new cases of prostate cancer are identified per year, with a 5-year survival rate of 98%. Survival rate decreases with aggressiveness of the disease¹(Figure 1.)
Every year, an estimated 1.3 million new prostate cancer cases emerge globally²
By 2030, the expected number of men with prostate cancer is estimated to be greater than 4.8 million^1,3

Although receiving a prostate cancer diagnosis is serious, many men survive the disease. Currently, there are about 3.1 million prostate cancer survivors in the United States.¹Early detection is key to survivability. The earlier prostate cancer is found and treated, the more probable a patient will remain free of the disease.

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Read the article on deciding when to perform a prostate biopsy a man with non-suspicious DRE findings

Article Prostate Health Index (phi) and Biopsy Decision Management

View data from the first large-scale multicenter trial evaluating the impact of phi testing on patient management and prostate biopsy decisions.

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What Tests are Used in Prostate Cancer Detection?

First-level screening for prostate cancer typically involves the use of prostate-specific antigen (PSA) testing and digital rectal examination (DRE)

Based on the results of screening tests, patients may undergo subsequent testing, including a prostate biopsy, to positively diagnose prostate cancer (Table 1).

Tests Used in Screening and Diagnosis of Prostate Cancer

First Line	Follow-up Tests
Prostate-specific antigen	Prostate biopsy
Digital rectal examination	Ultrasound
	Molecular genetic tests

Table 1. An array of prostate cancer screening and diagnostic tests are available to physicians.

Are PSA Tests Accurate for Assessing Risk of Prostate Cancer?
Prostate-specific antigen (PSA) testing is widely used as a screening tool for prostate cancer, but PSA levels between 4-10ng/ml do not provide physicians the clarity to perform biopsy.

PSA is not a cancer-specific marker. As such, there are considerations regarding PSA testing:

PSA concentrations are not definitive evidence for the presence or absence of prostate cancer
Elevated PSA may not indicate cancer
PSA is also present in non-cancerous conditions, such as benign prostatic hyperplasia
PSA levels are affected by acute and chronic prostatitis, as well as by physical trauma and inflammation

Only about 25% of men with tPSA in the 4-10 ng/mL range have a subsequent positive biopsy.^1,4 Determining PSA testing accuracy has been difficult because men with typical tPSA values will not undergo biopsy unless their DRE is abnormal. The work-up bias tends to overestimate the sensitivity and underestimate the specificity of the test.^5,6

How do Biopsies Impact Patients and the Healthcare Industry?
Biopsies are invasive procedures that may leave patients vulnerable to a number of risks. Many healthcare professionals are focused on reducing biopsy related complications.

As with any invasive medical procedure, biopsies bear certain risks. Reduced biopsies mitigates commonly occurring complications (Table 2):⁷

Complications and rate of occurrence after biopsy may include:

Complication	Rate of Occurrence
Infection	5-7%
Severe bleeding	0.4%-1.4%
Hematuria	50%
Rectal bleeding	30%
Hematospermia	50%
Urinary retention	<2%
Erectile dysfunction	Up to 90% (transient)

Table 2. Reduce complications and rate of occurrence of prostate cancer.⁷

Biopsies are also costly from an economic standpoint:

Depending on the type of prostate biopsy — local anesthesia, sedation anesthesia, transperineal or MRI-fusion biopsies — the cost could range from approximately $6,500–$16,800⁸
Spending on prostate cancer care increased from $11.8 billion to $14.8 billion from 2010 to 2017⁹ (Figure 2)
Over one-fifth (21.7%) of prostate biopsy expense is incurred during initial care — defined as the first six months of treatment in patients who survive for longer than 18 months⁹

In the U.S., prostate cancer annualized mean net cost of care has increased significantly.⁹

Chart showing the annualized mean initial and continuing costs of prostate cancer in men over and under the age of 65.

Figure 2. Net costs for cancer care for patients under 65 years of age total over $120,000 annually.

Prostate Health Index: Application and Results What is phi?

A simple blood test, phi provides better prostate cancer detection to reduce negative biopsies. The FDA-approved test combines PSA, free PSA and p2PSA tests.

Prostate Health Index results are based on a score that provides information on the probability of finding prostate cancer and providing confidence in biopsy decisions.

Learn more about how phi provides more confidence for patient prostate cancer care

Prostate Health Index (phi)

phi provides more confidence for patient care treatment decisions and reduces biopsy related complications. Find out how this simple blood test can be used as an aid in distinguishing prostate cancer from benign prostatic conditions, as well as how you can bring it to your laboratory or practice today.

Learn more

*Beckman Coulter, the stylized logo, and phi are trademarks or registered trademarks of Beckman Coulter, Inc.
¹National Cancer Institute (NCI). Cancer of the Prostate - Cancer Stat Facts. SEER. https://seer.cancer.gov/statfacts/html/prost.html. Accessed 24 Jul. 2019.
²Hoffman, RM. “Screening for Prostate Cancer.” Updated 16 Jul. 2019. https://www.uptodate.com/contents/screening-for-prostate-cancer . Accessed 14 Aug. 2019.
³U.S. Census Bureau. “American Community Survey 1-year estimates.” Retrieved from “Census Reporter Profile page for United States.” 2017. http://censusreporter.org/profiles/01000us-united-states/. Accessed 9 Sept. 2019.
⁴Draisma G, Etzioni R, Tsodikov A et. al. “Lead Time and Overdiagnosis in Prostate-specific Antigen Screening, Importance of Methods and Context.” J Natl Cancer Inst, vol. 1101, no. 6, 2009, pp. 374–383.
⁵White J, Shenoy BV, Tutrone RF et. al. “Clinical Utility of the Prostate Health Index (phi) for Biopsy Decision Management in a Large Group Urology Practice Setting.” Prostate Cancer Prostatic Dis, vol. 21, 2018, pp. 78–84.
⁶Tosoian JJ, Druskin SC, Andreas D et. al. “Use of the Prostate Health Index for Detection of Prostate Cancer Results from a Large Academic Practice,” Prostate Cancer Prostatic Dis, vol. 20, no. 2, 2017, 2013, pp. 228–233.
⁷Loeb S, Vellekoop A, Ahmed HU et. al. “Systematic Review of Complications of Prostate Biopsy.” Eur Urol, vol. 64, no. 6, 2013, pp. 876–892.
⁸Altok M, Chapin B, Pisters L et. al. “PD43-09 Cost Analysis of Different Prostate Biopsy Modalities.” J Urol, vol. 197, no. 4S, 14 May 2017, p. e821. https://www.auajournals.org/doi/10.1016/j.juro.2017.02.1914. Accessed 1 April 2017.
⁹Mariotto AB, Yabroff KR, Shao Y, Feuer EJ and Brown ML. “Projections of the Cost of Cancer Care in the United States: 2010–2020.” J Natl Cancer Inst, vol. 103, no. 2, 2011, pp. 117–128.
¹⁰Vincent GK and Velkoff VA. “The Next Four Decades: The Older Population in the United States: 2010 to 2050, Population Estimates and Projections.” U.S. Department of Commerce Economics and Statistics Administration, U.S. Census Bureau, P25-1138, 2010.
¹¹Loeb S, Sanda MG, Broyles DL et. al. “The Prostate Health Index (phi) Selectively Identifies Clinically-significant Prostate Cancer.” J Urol, vol. 193, no. 4, Epub 2014, pp. 1163–1169 doi: 10.1016/j.juro.2014.10.121.

*phi results are intended to be used as an aid in distinguishing prostate cancer from benign prostatic conditions in men 50 years of age and older with total PSA results in the 4-10 ng/mL range and negative digital rectal examination findings.

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