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