Name of the Procedure:

Biochemical Assay for High-Grade Prostate Cancer (Total PSA, Free PSA, Intact PSA, Human Kallikrein 2 [hK2]), using Plasma, with Patient Age, Digital Rectal Examination Status, and No History of Positive Prostate Biopsy

Summary

This procedure is a blood test used to evaluate the risk of high-grade prostate cancer. It involves measuring four specific proteins in the blood along with considering the patient's age and the results from a digital rectal examination (DRE). The proteins tested are Total PSA, Free PSA, Intact PSA, and Human Kallikrein 2 (hK2).

Purpose

The purpose of this procedure is to assess the likelihood of high-grade prostate cancer, a more aggressive form of prostate cancer. The goal is to provide a more accurate diagnosis, which can lead to more appropriate and timely treatment decisions.

Indications

• Elevated PSA levels
• Suspicious findings from a digital rectal examination
• Individuals at higher risk for prostate cancer (e.g., family history, older age)
• No previous history of positive prostate biopsy

Preparation

• Fasting is typically not required.
• It is important to inform the healthcare provider of any medications or supplements being taken.
• Patients may need to avoid ejaculation or vigorous exercise a few days before the test, as this can affect PSA levels.

Procedure Description

1. Blood sample collection: A healthcare professional will draw a blood sample from the patient's vein.
2. Protein assays: The blood sample is analyzed in a laboratory to measure levels of Total PSA, Free PSA, Intact PSA, and Human Kallikrein 2 (hK2).
3. Data integration: The protein levels are combined with patient age and DRE status to calculate the risk of high-grade prostate cancer.

Duration

The blood draw itself takes a few minutes. Laboratory analysis and integration of results may take several days.

Setting

The blood sample collection is typically performed in a hospital, outpatient clinic, or diagnostic laboratory.

Personnel

• Phlebotomist or nurse to draw the blood sample
• Laboratory technicians to analyze the blood sample
• Physician (e.g., urologist or oncologist) to interpret the results

Risks and Complications

• Minor discomfort or bruising at the blood draw site
• Rare risk of infection or excessive bleeding

Benefits

• Provides a more comprehensive risk assessment for high-grade prostate cancer
• May help avoid unnecessary biopsies
• Facilitates early and accurate diagnosis, leading to better treatment outcomes

Recovery

• There is no recovery period required as this is a minimally invasive procedure.
• Patients can typically return to normal activities immediately.
• Follow-up appointments may be scheduled to discuss results.

Alternatives

• Traditional PSA testing alone
• Advanced imaging techniques (e.g., MRI)
• Direct prostate biopsy (more invasive and has its own set of risks)

Patient Experience

• The blood draw is usually quick and involves minor discomfort.
• Patients may experience some anxiety while waiting for the results.
• The healthcare team will provide pain management options if necessary, although discomfort is typically minimal.