The American Society of Clinical Oncology (ASCO) has updated 2022 recommendations on the use of the radioligand therapy 177lutetium-PSMA-617 (177Lu-PSMA-617) for metastatic castration-resistant prostate cancer (mCRPC) to include another PSMA PET radiotracer for determining treatment eligibility.
That radiotracer, F-18 flotufolastat, received Food and Drug Administration approval on May 25, 2023. This approval was the sole reason for the update, according to the expert panel that prepared it. The panel now recommends that F-18 flotufolastat, Ga-68 PSMA-11, or F-18 piflufolastat be used as radiotracers to determine eligibility.
The therapy delivers targeted beta particle radiation to PSMA (prostate-specific membrane antigen)-expressing cancer cells.
The new guidance, which was published as an ASCO Guideline Rapid Recommendation Update in the Journal of Clinical Oncology, updates 2022 guidelines on systemic therapy for mCRPC that included recommendations on the use of 177Lu-PSMA-617.
Under the heading of “Practical Information,” the panel wrote that it “supports checking blood counts, renal, and hepatic function before each cycle of therapy. Radioprotection precautions must be taken in accordance with national and local regulations. The panel also supports multidisciplinary collaboration for the utilization of 177Lu-PSMA-617 where and when possible.”
“In light of recently published data, the new guidelines are appropriate and now offer a third radiotracer option to determine clinical eligibility for lutetium-based treatment,” said Jeffrey Tosoian, MD, who specializes in the surgical and non-surgical management of urologic cancers at the Vanderbilt University Medical Center in Nashville, Tennessee.
He added, “These updates are important to ensure that guideline recommendations remain aligned with the best available evidence.”
“The new guidelines are not just significant for urologists, but also medical oncologists, radiation oncologists, and nuclear medicine physicians. Treatment with Pluvicto [177Lu-PSMA-617] requires a multidisciplinary approach,” said Daniel Petrylak, MD, professor of medicine and urology at the Yale School of Medicine in New Haven, Connecticut.
“This addition now supports 3 tracer options for use in patient selection, which will hopefully improve access for patients who need to get a PSMA PET scan prior to treatment,” said Alicia Morgans, MD, MPH, a genitourinary medical oncologist and medical director of the Survivorship Program at Dana-Farber Cancer Institute in Boston, Massachusetts.
Dr Morgans also noted, “This guideline may provide clinicians who are applying for prior authorization for use of this PSMA PET tracer with a way to justify coverage, which is useful to the clinical team and the patient who needs the scan.”
David Penson, MD, MPH, chairman of the department of urology at Vanderbilt University Medical Center and director of the Vanderbilt Center for Surgical Quality and Outcomes Research, pointed out “that while insurance companies sometimes use the guidelines to make coverage decisions, this is not the only information they use. The purpose of guidelines is to help clinicians provide the highest quality care and not to guide insurance coverage decisions.”
Reference
Garje R, Rumble RB, Parikh RA, et al. Systemic therapy update on 177Lutetium-PSMA-617 for metastatic castration-resistant prostate cancer guideline: ASCO Guideline Update Rapid Recommendation Update. J Clin Oncol. Published online November 6, 2023. doi:10.1200/JCO.23.02128
