Weill Cornell Medicine has received a projected $4 million grant from the National Cancer Institute, part of the National Institutes of Health, to conduct a clinical trial testing whether a new imaging approach could reduce the need for biopsies to monitor prostate cancer.
The 5-year grant, with a possible 2-year extension, will evaluate whether adding an imaging modality called Prostate Specific Membrane Antigen (PSMA)- Positron Emission Tomography (PET) Computed Tomography (CT) to active surveillance regimens can rule out the presence of cancer that requires treatment. PSMA-PET CT uses a radioactive diagnostic agent to detect a protein that is found on the surface of prostate cells and at higher levels on prostate cancer cells. The technique is already used to detect the spread of cancer in men with high-risk prostate cancers and cancer recurrence in men who are in remission.
“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.
Prostate cancer is the second leading cause of cancer death in men in the United States. Yet, most older men diagnosed with prostate cancer have slow-growing, low-risk cancers that will not harm them during their lifetime. Rather than subject these men to surgery or radiation that may cause harmful side effects, most physicians recommend active surveillance instead.
These men undergo regular blood tests measuring prostate-specific antigen (PSA) levels, magnetic resonance imaging and biopsies to ensure that their cancer has not progressed into a more dangerous form. However, repeated biopsies can lead to infection, urination difficulties and other symptoms, causing many to stop monitoring their cancer.
Dr. McClure and his colleagues in the Molecular Imaging and Therapeutics division of the Department of Radiology and the Department of Pathology at Weill Cornell Medicine will test whether adding PSMA-PET CT can help improve the sensitivity and specificity of prostate cancer monitoring while reducing screening-related harms. The researchers will assign 200 men with low- or intermediate-risk prostate cancer who have opted for active surveillance to receive usual active surveillance protocol plus PSMA-PET CT. The trial will enroll patients at NewYork-Presbyterian/Weill Cornell Medical Center and four other sites. In addition to the NCI grant, the study is also receiving support from Lantheus, the company that produces a diagnostic agent used in PSMA-PET CT.
Dr. McClure is also teaming up with Dr. Mert Sabuncu, Vice Chair of Radiology Research and a Professor of Electrical Engineering in Radiology at Weill Cornell Medicine, to develop a machine learning algorithm that can predict which patients with prostate cancer will progress to a stage requiring treatment. Dr. Sabuncu is also a professor in the School of Electrical and Computer Engineering at Cornell University’s Ithaca campus and Cornell Tech. Additionally, genomic data from the PSA blood tests will help identify genetic signatures indicating a patient at greater risk who may benefit from earlier therapy rather than active monitoring.
“Our trial leverages cross-sector collaboration to innovate and streamline care for patients with prostate cancer,” said Dr. McClure, who is also a urologist at NewYork-Presbyterian/Weill Cornell Medical Center. “We hope to develop alternatives for prostate cancer surveillance that help us more effectively stratify which patients need treatment.”
Many Weill Cornell Medicine physicians and scientists maintain relationships and collaborate with external organizations to foster scientific innovation and provide expert guidance. The institution makes these disclosures public to ensure transparency. For this information, see profile for Dr. Timothy McClure.
The research described in this study is supported in part by the National Cancer Institute, part of the National Institutes of Health, through grant number 5R37CA282407.