The NCCN has added Ga 68– and F 18–based PSMA-PET imaging modalities to its clinical practice guidelines for prostate cancer.1
“The updated guidelines will encourage clinicians to use PSMA-PET as a primary imaging modality in patients and will deliver the benefit of a more streamlined approach. We look forward to having access to this functional form of imaging as new products come into the market,” Oliver Sartor, MD, Medical Director at Tulane Cancer Center, stated in a news release from Telix pharmaceuticals, a manufacturer of PSMA-PET imaging products.
According to the release, “The NCCN panel has recognized the increased sensitivity and specificity of PSMA-PET tracers, compared to conventional imaging (CT, MRI) for detecting micrometastatic disease, at both initial staging and biochemical recurrence. The updated guidelines state that the NCCN Panel does not feel that conventional imaging is a necessary prerequisite to PSMA-PET and that PSMA-PET/CT or PSMA-PET/MRI can serve as equally effective, if not more effective front-line imaging tools for these patients.”1
The FDA based its decision on the safety and efficacy of Ga 68 PSMA-11 proven in 2 prospective clinical trials with a total of 960 men with prostate cancer who each received 1 injection of the drug.
In the first trial, 325 patients who were candidates for surgical removal of the prostate gland and pelvic lymph nodes and were considered at higher risk for metastasis underwent PET/CT or PET/MRI scans performed with Ga 68 PSMA-11. Of the patients who went on to undergo surgery, Ga 68 PSMA-11 PET demonstrated a clinically important rate of metastatic cancer confirmed by surgical pathology in patients with positive readings in the pelvic lymph nodes.
In the second trial, 635 patients who had rising serum PSA levels after initial prostate surgery or radiotherapy, 74% had at least 1 positive lesion detected by Ga 68 PSMA-11 PET in at least 1 body region. In total, 91% of patients with positive Ga 68 PSMA-11 PET readings who had correlative tissue pathology from biopsies, who also had results from baseline or follow-up imaging by conventional methods, and serial PSA levels available for comparison, also had local recurrence or metastasis of prostate cancer confirmed.
Other Ga68-based PSMA imaging products are in the pipeline, including TLX591-CDx (Illuccix), a radiopharmaceutical cold kit for the preparation of 68Ga-PSMA-11 injection that is currently under review for FDA approval.
“The NCCN guidelines are considered a global standard to guide oncology practice and reimbursement. The inclusion of PSMA-PET imaging, including with Ga-68 , the isotope used in our investigational imaging product Illuccix further signals the emergence of PSMA-PET imaging as a state-of-the-art imaging modality,” stated Sartor.1
The approval was based on findings from the CONDOR and OSPREY studies. In the CONDOR study, 63.9% of men with biochemically recurrent prostate cancer who had no evidence of disease on standard-of-care imaging had a change in intended management after their piflufolastat F 18 scan.4
“We are extremely pleased that the NCCN panel of prostate cancer experts, who are dedicated to high-quality, high-value, patient-centered cancer care, have added PSMA-targeted PET imaging with piflufolastat F 18 in unfavorable intermediate, high and very high risk as well as recurrent disease to the updated 2021 guidelines, for the management of prostate cancer,” Bela Denes, MD, vice president of Medical Affairs at Lantheus, the developer of piflufolastat F 18, stated in a press release. “In addition to FDA approval, inclusion in the guidelines further validates PYLARIFY’s performance and utility and will raise awareness within the medical community and payors of the potential impact of this novel PSMA-targeted imaging agent in the care of men with prostate cancer.”
1. NCCN Guidelines Updated to Include PSMA-PET Imaging. Posted online September 13, 2021. Accessed September 15, 2021. https://bit.ly/3kbCgJF.
2. FDA approves first PSMA-targeted PET imaging drug for men with prostate cancer. Press release. FDA. December 1, 2020. Accessed December 1, 2020. https://bit.ly/3fWUOcN.
3. Lantheus Receives U.S. FDA Approval of PYLARIFY® (piflufolastat F 18) Injection, the First and Only Commercially Available PSMA PET Imaging Agent for Prostate Cancer. Published online May 27, 2021. Accessed May 27, 2021. https://bwnews.pr/3vtMgBh.
4. Morris MJ, Rowe SP, Gorin MA, et al. Diagnostic performance of 18F-DCFPyL-PET/CT in men with biochemically recurrent prostate cancer: results from the CONDOR phase 3, multicenter study [published online before print February 26, 2021.] doi: 10.1158/1078-0432.CCR-20-4573