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Oncology (high-grade prostate cancer), biochemical assay of four proteins (Total PSA, Free PSA, Intact PSA, and human kallikrein-2 [hK2]), utilizing plasma or serum, prognostic algorithm reported as a probability score

CPT4 code

Name of the Procedure:

Biochemical Assay for High-Grade Prostate Cancer

  • Common Name: PSA and hK2 Tests
  • Technical Terms: Biochemical Assay of Total PSA, Free PSA, Intact PSA, and human Kallikrein-2 [hK2]

Summary

This procedure involves the analysis of specific proteins in the blood to assess the likelihood of high-grade prostate cancer. A blood sample is tested for Total PSA, Free PSA, Intact PSA, and human kallikrein-2 (hK2), and the results are used in a prognostic algorithm that provides a probability score indicating cancer risk.

Purpose

This test is used to evaluate the risk of aggressive prostate cancer. The goal is to determine if further diagnostic procedures, such as a biopsy, are needed, and to help in developing an appropriate treatment plan.

Indications

  • Elevated PSA levels from initial screening
  • Family history of prostate cancer
  • Previous negative biopsy with ongoing suspicion of prostate cancer
  • Age and other risk factors suggesting higher risk of prostate cancer

Preparation

  • No special preparation is typically required
  • Patients may be advised to avoid ejaculation or vigorous physical activity for 48 hours before the test, as these can affect PSA levels
  • Inform your doctor about any medications or supplements you are taking

Procedure Description

  1. A blood sample is drawn from the patient, usually from a vein in the arm.
  2. The blood sample is sent to a laboratory for analysis.
  3. The levels of Total PSA, Free PSA, Intact PSA, and human kallikrein-2 (hK2) are measured.
  4. The results are input into a prognostic algorithm that calculates a probability score indicating the risk of high-grade prostate cancer.

Duration

The blood draw itself takes only a few minutes. Results from the laboratory analysis are typically available within a few days to a week.

Setting

The blood sample is usually collected in an outpatient clinic, physician's office, or a laboratory.

Personnel

  • Phlebotomist or nurse for drawing blood
  • Laboratory technician for analyzing the sample
  • Physician for interpreting the results

Risks and Complications

  • Minor discomfort or bruising at the site of blood draw
  • Rarely, infection or prolonged bleeding at the puncture site

Benefits

  • Provides a non-invasive method to assess the risk of aggressive prostate cancer
  • Helps to avoid unnecessary biopsies
  • Facilitates early detection and treatment planning, which can improve outcomes

Recovery

  • Minimal recovery time needed
  • Patients can resume normal activities immediately after the blood draw
  • Follow-up appointments may be scheduled to discuss results and next steps

Alternatives

  • Standard PSA test without additional protein markers
  • Digital rectal exam (DRE) for initial screening
  • Imaging tests such as MRI
  • Direct biopsy for definitive diagnosis
  • Pros: Some alternatives may provide immediate diagnosis
  • Cons: Alternatives like biopsy are more invasive with higher risks of complications

Patient Experience

  • During the procedure: Minor pain or discomfort from the needle stick
  • After the procedure: Minimal to no pain, and normal activities can be resumed immediately
  • Pain management: Typically not required, but over-the-counter pain relief can be used if needed

Medical Policies and Guidelines for Oncology (high-grade prostate cancer), biochemical assay of four proteins (Total PSA, Free PSA, Intact PSA, and human kallikrein-2 [hK2]), utilizing plasma or serum, prognostic algorithm reported as a probability score

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