‘Practice changing’: New research underscores clinical benefits of PSMA-PET for prostate cancer
Physicians can reliably diagnose prostate cancer in patients with positive 68Ga-PSMA-11 PET exams, according to research published Thursday. Those involved said the results are “practice changing.”
UCLA and the University of California, San Francisco, shared the conclusions from their prospective, multicenter study in JAMA Oncology.
PET scans correctly diagnosed 95% of cases as negative when high-risk patients did not ultimately have pelvic lymph node metastasis, otherwise known as specificity. But 60% of participants had lesions too small to detect.
Senior author Jeremie Calais, MD, MSc, assistant professor of nuclear medicine and theranostics at UCLA, said the results are “huge.” Despite its low sensitivity, 68Ga-PSMA-11 PET is still better than any other imaging technique available, he noted.
“As such, these results are practice changing for the nuclear medicine physicians, urologists, and medical oncologists who will manage this cohort of patients,” authors of the Sept. 16 investigation wrote.
Back in December, the U.S. Food and Drug Administration used data from this trial to approve Ga-68 PSMA-11 for use in patients whose cancer is believed to have spread but is potentially curable via surgery or radiation therapy. It became the first FDA-approved PSMA-targeted PET tracer for men with prostate cancer.
This single-arm, phase 3 trial included 764 men with intermediate- to high-risk cancer who underwent a 68Ga-PSMA-11 PET scan between December 2015-2019.
One key finding, Calais noted, is that only 277 of 764 patients who got a scan had their tumor surgically removed. Nearly 64% opted for treatment because their results showed cancer outside the prostate and surgery was no longer ideal.
The molecular imaging approach detected disease spreading to the pelvic lymph nodes in 40% of patients who actually had metastases, known as sensitivity. At the same time, PET scans notched a 95% specificity, which is “very high,” Calais explained.
Calais added that insurance coverage for the technique “will follow soon,” he said in a Q&A published Sept. 16. The National Comprehensive Cancer Network also recently updated its guidelines to include the imaging agent.
Calais sees more good news on the horizon.
“Access to PSMA-PET will be widely available and this game-changer technology will ultimately become part of the routine staging of prostate cancer patients,” the UCLA doctor noted. “Like doing a PSA test, I anticipate in a near future that physicians will routinely require a PSMA PET scan before making a treatment plan.”
Read the full JAMA Oncology study here, including a related editorial here.