Oncology (prostate) gene expression profile by real-time RT-PCR of 3 genes (ERG, PCA3, and SPDEF), urine, algorithm reported as risk score
CPT4 code
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
- The patient provides a urine sample, usually collected first thing in the morning.
- The urine sample is analyzed using real-time RT-PCR technology, which measures the expression levels of the genes ERG, PCA3, and SPDEF.
- An algorithm processes these expression levels to generate a risk score for prostate cancer.
- 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.