Method is a ‘game changer’ that should become the standard of care, say UCSF researchers who validated its effectiveness

UCSF urologists and their nuclear medicine teams -- led by Drs Peter Carroll and Thomas Hope -- have obtained approval from the U.S. Food and Drug Administration to offer a new imaging technique for prostate cancer that locates cancer lesions in the pelvic area and other parts of the body to which the tumors have migrated. This work was also done in conjunction with colleagues at UCLA.

Known as prostate-specific membrane antigen PET imaging, or PSMA PET, the technique uses positron emission tomography in conjunction with a PET-sensitive drug that is highly effective in detecting prostate cancer throughout the body so that it can be better and more selectively treated. The PSMA PET scan also identifies cancer that is often missed by current standard-of-care imaging techniques.

A clinical trial conducted by the UCSF and UCLA research teams on the effectiveness of PSMA PET proved pivotal in garnering FDA approval for the technique at both universities. The PSMA drug used in the technique was developed outside the U.S. by the University of Heidelberg.

“It is rare for academic institutions to obtain FDA approval of a drug,” said Dr. Thomas Hope, an Associate Professor of Radiology at UCSF. “We hope that this first step will lead to a more widespread availability of this imaging test to men with prostate cancer throughout the country.”

How It Works

For men who are initially diagnosed with prostate cancer or who were previously treated but who have experienced a recurrence, a critical first step is to understand the extent of the cancer. Current imaging is limited in locating cancer cells at early stages so they can be treated.

PSMA PET works using a radioactive tracer drug called 68Ga-PSMA-11, which is injected into the body and attaches to proteins known as prostate-specific membrane antigens. Because prostate cancer tumors overexpress these proteins on their surface, the tracer enables physicians to pinpoint their location.

The current standard of care in prostate imaging is a technique called fluciclovine PET, which involves injecting patients with fluciclovine, a synthetic radioactive amino acid.

In their research comparing PSMA PET and fluciclovine PET, UCSF research teams found that imaging with PSMA PET was able to detect significantly more prostate lesions than fluciclovine PET in men who had undergone a radical prostatectomy but had experienced a recurrence of their cancer. Their findings indicate that PSMA PET should be strongly considered both before initial treatment in men with high-risk cancers and in cases of cancer recurrence after surgery or radiation to provide more precise care. The PSMA tracer also can be used in conjunction with CT or MRI scans.

UCSF and UCLA are the only two medical centers in the U.S. that can offer PSMA PET to the public through this FDA approval. A limited number of other U.S. medical centers are currently using PSMA as an investigational technique, generally as part of a clinical trial. However, more hospitals will have the opportunity to adopt the technology after applying for expedited FDA approval, which is now possible as a result of the initial FDA approval gained by the University of California research.

“I believe PSMA PET imaging in men with prostate cancer is a game changer because its use will lead to better, more efficient and precise care,” said Dr. Peter Carroll, a professor at the UCSF Helen Diller Family Comprehensive Cancer Center.

“Prostate cancer is one of the most common cancers in men in the U.S. One in eight men will be diagnosed with prostate cancer in their lifetime, and, according to the American Cancer Society, almost 250,000 men will be diagnosed in 2021 alone,” said Dr. Raj S. Pruthi, Professor and Chair of the Department of urology at UCSF. “These numbers highlight the importance of this major effort and breakthrough between UCSF and our partners at UCLA to help improve the diagnosis and treatment of men with prostate cancer.”

The UCSF research team was led by faculty from the molecular imaging and therapeutics section of the department of radiology and biomedical imaging, who worked in collaboration with the departments of urology, radiation oncology and medical oncology. Support was provided by the UCSF Helen Diller Family Comprehensive Cancer Center and a philanthropic gift to the UCSF Department of Urology, and by the Prostate Cancer Foundation.

“‘Game changer’ is almost an understatement for how prostate cancer patient care could be improved by this technique,” said Dr. Jonathan W. Simons, CEO of the Prostate Cancer Foundation. “After investing more than $26 million in research on PSMA over many years, we are honored to congratulate the research teams at UCSF and UCLA on their milestone achievement.”

For information about PSMA PET patient care, visit the UCSF websites.

The UCSF Helen Diller Family Comprehensive Cancer Center (HDFCCC) integrates the work of researchers and clinicians who are dedicated to four fundamental pursuits: laboratory research into the causes and events of cancer’s progression; clinical research to translate new knowledge into viable treatments; compassionate, state-of-the-art patient care; and population research that can lead to prevention, early detection, and quality-of-life improvement for those living with cancer. The HDFCCC holds the National Cancer Center’s designation as a comprehensive cancer center. The Center’s 420-plus members and associate members represent dozens of departments and institutes across UCSF, which is the only University of California campus devoted exclusively to the health sciences. Members are faculty investigators in laboratory, clinical, and population-based research who collaborate across the cancer spectrum, from basic biology to risk factors and prevention and control strategies. For more, visit cancer.ucsf.edu.