Name of the Procedure:

Oncology (prostate) gene expression profile by real-time RT-PCR of 3 genes (ERG, PCA3, and SPDEF), urine, algorithm reported as risk score.

Summary

This procedure involves analyzing the expression levels of three specific genes (ERG, PCA3, and SPDEF) from a urine sample to assess the risk of prostate cancer. The results are used to develop a risk score that helps guide further diagnostic or treatment decisions.

Purpose

This test is used to evaluate the risk of prostate cancer in patients. The goals are to provide a non-invasive method to identify individuals who may need further diagnostic procedures like biopsies, and to potentially improve early detection and treatment planning.

Indications

• Elevated prostate-specific antigen (PSA) levels.
• Family history of prostate cancer.
• Unexplained urinary symptoms.
• Abnormal findings during a digital rectal exam.
• Need for additional information before deciding on a prostate biopsy.

Preparation

• The patient may be advised to avoid vigorous physical activity or sexual activity for a couple of days before providing a urine sample.
• No specific fasting or medication adjustments are typically required.

Procedure Description

1. The patient provides a urine sample, usually collected first thing in the morning.
2. The urine sample is analyzed using real-time RT-PCR technology, which measures the expression levels of the genes ERG, PCA3, and SPDEF.
3. An algorithm processes these expression levels to generate a risk score for prostate cancer.
4. The score is reviewed by the healthcare provider to guide further diagnostic or treatment steps.

Duration

The actual urine collection takes a few minutes. The gene expression analysis may take several hours to a few days, depending on the laboratory's workflow.

Setting

The procedure is performed in an outpatient setting, such as a urologist's office or a diagnostic laboratory.

Personnel

The procedure involves:

• The patient for urine sample collection.
• Medical laboratory technologists or scientists for performing the RT-PCR analysis.
• Urologists or oncologists for interpreting the risk score and discussing the results with the patient.

Risks and Complications

• Minimal to no risk involved with providing a urine sample.
• Slight risk of inaccurate results leading to either unnecessary anxiety or false reassurance.
• Potential need for further diagnostic tests if results indicate a high risk.

Benefits

• Non-invasive and relatively simple procedure.
• Provides valuable information that can help in early detection of prostate cancer.
• Can help avoid unnecessary invasive procedures like biopsies.

Recovery

• No recovery time since the procedure is non-invasive.
• Normal activities can be resumed immediately after providing the urine sample.
• Follow-up appointments may be scheduled to discuss results and plan further action if needed.

Alternatives

• PSA blood test.
• Digital rectal exam.
• Prostate biopsy if more definitive diagnostic information is needed.
• Multiparametric MRI of the prostate.
• Each alternative has its pros and cons in terms of invasiveness, accuracy, and risk.

Patient Experience

• The patient will need to provide a urine sample, which is straightforward and typically painless.
• During and after the procedure, there should be no discomfort.
• Anxiety related to waiting for and receiving test results is common; healthcare providers offer guidance and support.