Name of the Procedure:

Oncology (Prostate), mRNA Gene Expression Profiling by Real-Time RT-PCR of 46 Genes (31 Content and 15 Housekeeping) Utilizing Formalin-Fixed Paraffin-Embedded Tissue, Algorithm Reported as a Disease-Specific Mortality Risk Score

Summary

This medical test analyzes the expression of 46 specific genes from a prostate tissue sample. It uses a technology called real-time RT-PCR to measure gene activity levels and an advanced algorithm to estimate the patient's risk of dying from prostate cancer.

Purpose

This procedure helps in understanding the aggressiveness of prostate cancer. It aims to provide a personalized mortality risk score, aiding doctors in making more informed treatment decisions.

Indications

• Elevated Prostate-Specific Antigen (PSA) levels.
• Abnormal findings in a digital rectal exam.
• Confirmed diagnosis of prostate cancer.
• Patients needing risk assessment for deciding between active surveillance and aggressive treatment.

Preparation

• No special preparation is required for the gene expression profiling itself.
• A biopsy procedure would have been conducted previously to obtain the formalin-fixed paraffin-embedded tissue.
• Patients should follow their doctor’s instructions regarding any ongoing treatment or medication adjustments.

Procedure Description

1. A previously obtained biopsy sample (stored in formalin-fixed paraffin-embedded tissue) is prepared.
2. RNA is extracted from the tissue sample.
3. The RNA is converted into complementary DNA (cDNA) using reverse transcription.
4. Real-time RT-PCR is then used to measure the expression of 46 genes (31 content genes related to cancer and 15 housekeeping genes for normalization).
5. The data is fed into an algorithm that calculates a disease-specific mortality risk score, offering a valuable insight into the cancer's behavior.

Duration

The analysis and interpretation of results typically take several days to a week.

Setting

The test is performed in a specialized laboratory with capabilities for molecular diagnostics.

Personnel

• Pathologists specializing in molecular diagnostics.
• Laboratory technicians trained in real-time RT-PCR.
• Genetic counselors or oncologists who interpret the results.

Risks and Complications

• As the procedure is conducted on a previously obtained tissue sample, there are no direct risks from this test.
• Potential issues may arise if the tissue sample is not of adequate quality or quantity for successful RNA extraction.

Benefits

• Personalized risk assessment for prostate cancer mortality.
• Enhanced decision-making for treatment planning.
• Potential to avoid overtreatment or ensure timely aggressive therapy, improving patient outcomes.

Recovery

• Since the procedure involves analysis of an existing tissue sample, there is no physical recovery required.
• Patients may need to discuss results and subsequent decisions with their healthcare provider.

Alternatives

• Traditional histopathological analysis of the tissue sample.
• Other molecular tests like DNA sequencing.
• Pros: These approaches might be used based on availability and clinical guidelines.
• Cons: They may not provide as detailed a risk assessment specific to mortality.

Patient Experience

• Patients will not feel any physical effects from this test, as it is performed on a previously collected tissue sample.
• There can be emotional aspects regarding the wait for results and subsequent discussions about treatment options.
• Healthcare providers will offer support and information to help with understanding and managing any anxiety related to the test outcomes.