Addressing PSA Specificity Webinar

When used in conjunction with a DRE, the Siemens portfolio of PSA assays can provide clinicians with the information they need to optimize patient assessment and care strategies, and reduce the anguish and cost of unnecessary prostate biopsies.

• Our assays can help clinicians decide if a biopsy is necessary, and may help resolve the type of prostate issue a patient has
• An understanding of the diagnostic gray zone—when patients exhibit a total serum PSA of between 4.0–10 ng/mL — increases appropriate selection of patients for biopsy, and may reduce negative biopsies

The patient stratification illustrated below shows how PSA and fPSA assays can be used to assist patient management following an initial PSA test and DRE. Diagnostic testing using the Siemens portfolio of PSA assays increases the likelihood of a patient who is sent for prostate biopsy testing positive. A prostate biopsy is required for the diagnosis of cancer. PSA and fPSA concentrations, regardless of the value, should not be interpreted as definitive evidence for the presence or absence of prostate cancer.

PSA testing is clinically accepted by the NCCN, NACB and EGTM for both detection and monitoring^{1, 2}

• Quantitatively measures prostate specific antigen in serum
• Classic method to aid in the detection of prostate cancer
• It is used in conjunction with a digital rectal examination (DRE)

Our Third Generation PSA assay aids in the detection of prostate cancer and is used as an adjunctive test to aid in the management of prostate cancer patients.

• Provides information on possible relapse in facilitating patient management
• Provides an early indication of disease status after treatment when used in conjunction with other clinical information³.
• Approved for prostate cancer screening in conjunction with a digital rectal examination (DRE)

Our fPSA assay helps to guide decision-making in men 50 years or older who have DRE findings not suspicious of cancer who are in the diagnostics gray zone (4.0–10 ng/mL).

• Percent free PSA assessment may help to reduce unnecessary biopsies^4,5
• It helps to differentiate cancer from benign prostatic hyperplasia
• Percent free PSA is lower in prostate cancer than in benign prostate hyperplasia^4,5

The Siemens proprietary Complexed PSA is an alternative to traditional PSA testing for frontline detection.

• PSA complexed with ACT comprises a higher proportion of PSA in men with prostate cancer^6-8
• It is recommended by the NCCN as a frontline detection test
• It is used in conjunction with a digital rectal examination (DRE)

1: NACB Laboratory Medicine Practice Guidelines. Use of Tumor Markers in Testicular, Prostate, Colorectal, Breast and Ovarian Cancers. 2009
2: The IMMULITE Third Generation PSA assay has not been evaluated and approved by the FDA for us with the IMMULITE Free PSA assay in the precent free PSA calculations.
3: Shen, et al. Ultrasensitive serum prostate specific antigen nadir accurately predicts the risk of early relapse after radical prostatectomy. J of Urol 2005; 173; 777-780.
4: Catalona WJ, Partin AW, Slawin KM, Brawer MK, Flanigan RC, Patel A, Richie JP, deKernion JB, Walsh PC, Scardino PT, Lange PH, Subong EN, Parson RE, Gasior GH, Loveland KG, Southwick PC. Use of the percentage of free prostate-specific antigen to enhance differentiation of prostate cancer from benign prostatic disease: a prospective multicenter clinical trial. JAMA. 1998 May 20;279(19):1542-7.
5: Lilja, et al. Significance of different molecular forms of serum PSA. Urol C Clin North Am 1993; 20:681:686.
6: Brawer MK, Cheli CD, Neaman IE, Goldblatt J, Smith C, Schwartz MK, Bruzek DJ,Morris DL, Sokoll LJ, Chan DW, Yeung KK, Partin AW, Allard WJ. Complexed prostate specific antigen provides significant enhancement of specificity compared with total prostate specific antigen for detecting prostate cancer. J Urol. 2000 Nov;164(5):1671-2.
7: Lilja H, Christtensson A, Matikainen M-T, et al. Prostate-specific antigen occurs predominantly in complex alpha-1-antichymotrypsin. Clin Chem 1991 ; 7 :1618-25.
8: Stenman UH, Leinonen J, Alfthan H, et al. A complex between prostate-specific antigen and alpha-1-antichymotrypsin is the major form of prostate-specific antigen in serum of patients with prostatic cancer: Assay of the complex improves clinical sensitivity for cancer. Cancer Res 1991; 51: 222-6.