Today’s announcement from the FDA has been long awaited by the prostate cancer community. We expect several more PSMA-PET approvals to follow in the coming weeks.
This approval is based on studies led by Prostate Cancer Foundation-funded investigators Dr. Thomas Hope at UCSF and Dr. Czernin and Dr. Calais at UCLA. The team conducted a series of clinical trials which demonstrated the improved sensitivity of 68Ga-PSMA-11 PET for detecting sites of recurrent prostate cancer in men with rising PSA levels after surgery or radiation therapy, and for detecting sites of metastases in men newly diagnosed with high-risk prostate cancer.
Compared to the scans currently used for prostate cancer detection, such as CT, bone scans, and MRI, PSMA PET is more sensitive and can detect much smaller prostate cancer metastases. Several of AnCan’s members have already received PSMA PET scans in clinical trials and we have personally experienced negative scans with the old technology and then positive scans with the PSMA agents and it has changed our treatment decisions. PSMA PET can now be used for initial and subsequent management decisions in patients with prostate cancer, in order to determine if and where they have metastases.
At present, 68Ga-PSMA-11 PET scanning will be available at only UCLA and UCSF. Radiopharmaceutical companies will likely apply for expedited FDA approval to make 68Ga-PSMA-11 “kits” so that this technique will eventually be available to more patients throughout the US.
No serious adverse reactions were attributed to Ga 68 PSMA-11. There is a risk for misdiagnosis because Ga 68 PSMA-11 binding may occur in other types of cancer as well as certain non-malignant processes which may lead to image interpretation errors. There are radiation risks because Ga 68 PSMA-11 contributes to a patient’s overall long-term cumulative radiation exposure, which is associated with an increased risk for cancer, however small.
To read the full stories of this approval, please click on these links from the FDA and from the Prostate Cancer Foundation (PCF):