Prostate cancer is the second leading cause of cancer-related death among men in the United States. However, the majority of older men diagnosed with prostate cancer have slow-growing, low-risk forms of the disease that are unlikely to cause harm during their lifetime. Rather than subjecting these individuals to surgery or radiation, which may result in harmful side effects, most doctors recommend active surveillance. This approach involves regular monitoring through blood tests to measure prostate-specific antigen (PSA) levels, magnetic resonance imaging (MRI), and biopsies to track any progression of the cancer into a more dangerous form. Unfortunately, repeated biopsies can lead to complications such as infections, difficulty urinating, and other symptoms, prompting many patients to discontinue their cancer monitoring. Now, researchers are conducting a clinical trial to assess whether a new imaging method could reduce the need for biopsies in the monitoring of prostate cancer.

The clinical trial, led by researchers at Weill Cornell Medicine (New York, NY, USA), is investigating whether adding a technique known as Prostate Specific Membrane Antigen (PSMA)-Positron Emission Tomography (PET) Computed Tomography (CT) to standard active surveillance protocols can help identify the presence of cancer that requires treatment. PSMA-PET CT uses a radioactive tracer to detect a protein present on the surface of prostate cells, which is found at elevated levels on prostate cancer cells. This imaging method is already used for detecting cancer spread in men with high-risk prostate cancers and for identifying cancer recurrence in men who are in remission.

The goal of the trial is to determine whether incorporating PSMA-PET CT into active surveillance can enhance the sensitivity and specificity of prostate cancer monitoring while minimizing the risks associated with frequent screenings. The study will involve 200 men with low- or intermediate-risk prostate cancer who have chosen active surveillance. These participants will receive the usual active surveillance protocol in addition to PSMA-PET CT scans. The trial will be conducted at NewYork-Presbyterian/Weill Cornell Medical Center and four other locations. Furthermore, the research team is developing a machine learning algorithm designed to predict which patients with prostate cancer are likely to progress to a stage that requires treatment. Genomic data obtained from PSA blood tests will also be used to identify genetic markers that may indicate a higher risk, helping to identify patients who may benefit from earlier intervention instead of continued monitoring.
“We hope to use PSMA-PET CT as a less invasive and less costly alternative to biopsy in men undergoing active surveillance for low or moderate-risk prostate cancers,” said the study’s principal investigator Dr. Timothy McClure, an assistant professor of urology and radiology in the Division of Interventional Radiology at Weill Cornell Medicine. “Our trial leverages cross-sector collaboration to innovate and streamline care for patients with prostate cancer. We hope to develop alternatives for prostate cancer surveillance that help us more effectively stratify which patients need treatment.”

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