Trial explores 177Lu-PSMA-617 plus ADT and androgen receptor pathway inhibitor in mHSPC

In this video Alicia Morgans, MD, MPH, discusses the international, prospective, open-label, randomized, phase 3 PSMAddition study (NCT04720157),¹ which is comparing ¹⁷⁷Lu-psma-617 (lutetium Lu 177 vipivotide tetraxetan; Pluvicto) in combination with standard of care (SOC) versus SOC alone in in adult male patients with metastatic hormone-sensitive prostate cancer (mHSPC). SOC is androgen-deprivation therapy (ADT) plus an androgen receptor pathway inhibitor. The enrollment goal for the trial is over 1100 patients. The primary study end point is radiographic progression-free survival, with the key secondary end point being overall survival.

Morgans is a member, faculty of medicine, Harvard Medical School, and medical director, Survivorship Program, Dana-Farber Cancer Institute.

Video Transcript

One of the areas of really high interest in prostate cancer is radiopharmaceutical use and there is a study now called PSMAddition, which is combining ADT and ¹⁷⁷Lu-PSMA-617 along with our androgen receptor signaling inhibitors to see if that triplet combination is better than ADT and an androgen receptor signaling inhibitor alone in patients with mHSPC. I think that's of high interest because we just really are getting to use ¹⁷⁷Lu-PSMA-617 for some of the first patients and standard of care use at this point in time and so having the opportunity to move that agent from the very advanced metastatic castration-resistant prostate cancer setting into that hormone-sensitive setting is really exciting and I think really hopeful, because we know that that's a relatively well-tolerated treatment for most patients, and in combination with an AR signaling inhibitor is probably still going to be pretty well tolerated. So that study is one of the most highly anticipated of all of the metastatic hormone-sensitive setting trials that we have going on at this time.

The transcript has been edited for clarity.

Reference
1. NIH ClinicalTrials.gov. An International Prospective Open-label, Randomized, Phase III Study Comparing 177Lu-PSMA-617 in Combination With SoC, Versus SoC Alone, in Adult Male Patients With mHSPC (PSMAddition). Last updated January 2mri0, 2023. Accessed January 23, 2023. https://clinicaltrials.gov/ct2/show/NCT04720157