Nitin Yerram, MD, highlights trial of 177Lu-PSMA-617 in localized prostate cancer

¹⁷⁷Lu-PSMA-617 (Pluvicto) was approved by the FDA in March 2022 for patients with metastatic castration-resistant prostate cancer who have received prior treatment with an androgen receptor pathway inhibitor and taxane-based chemotherapy.¹ In March 2025, the FDA approved a label expansion to move the radioligand therapy into the pre-chemotherapy setting.²

The agent is currently being assessed in the phase 2 PRELUDE trial (NCT06798558) for adult patients with high-risk localized prostate cancer who are set to undergo radical prostatectomy.³

The trial is assessing the oncological outcomes with neoadjuvant ¹⁷⁷Lu-PSMA-617 in this patient population. In a recent interview with Urology Times®, Nitin K. Yerram, MD, shares the background and design for the study.

He explained, “As we know, high-risk prostate cancer imposes a challenge for everybody in this country. These are patients who have high degree of recurrence, and their treatment outcomes are not always positive long-term. There have been other neoadjuvant studies, treatment that they've given before surgery, to help those outcomes, but they haven't panned out to be successful.”

Yerram is a urologic oncologist at Hackensack University Medical Center in New Jersey.

In total, the prospective, single-arm PRELUDE trial is aiming to enroll 54 patients with high-risk, localized prostate cancer across 3 clinical trials sites in the US. To be eligible for enrollment, patients need to have histologically confirmed adenocarcinoma of the prostate, high-risk disease, a life expectancy greater than 10 years, and a positive PSMA scan on ⁶⁸Ga-PSMA-11 PET/CT.

Those included in the trial will receive 2 cycles of ¹⁷⁷Lu-PSMA-617 administered at the dose level of 7.4 GBq once every 6 weeks. The primary end point is prostate cancer pathological downstaging.

Completion of the trial is anticipated for March 2029.

Yerram added, “We're able to hopefully see some benefit, but the exciting part is we're able to offer the newest and most exciting treatment to our patients on this clinical trial.”

REFERENCES

1. Novartis Pluvicto approved by FDA as first targeted radioligand therapy for treatment of progressive, PSMA positive metastatic castration-resistant prostate cancer. News release. Novartis. March 23, 2022. Accessed April 21, 2025. https://www.novartis.com/news/media-releases/novartis-pluvictotm-approved-fda-first-targeted-radioligand-therapy-treatment-progressive-psma-positive-metastatic-castration-resistant-prostate-cancer

2. FDA approves Novartis radioligand therapy Pluvicto for earlier use before chemotherapy in PSMA-positive metastatic castration-resistant prostate cancer. News release. Novartis Pharma AG. Published online and accessed April 21, 2025. https://www.novartis.com/news/media-releases/fda-approves-novartis-radioligand-therapy-pluvicto-earlier-use-chemotherapy-psma-positive-metastatic-castration-resistant-prostate-cancer

3. Neoadjuvant Lu-177-PSMA-617 in patients with high risk localized prostate cancer undergoing radical prostatectomy. ClinicalTrials.gov. Last updated March 11, 2025. Accessed April 21, 2025. https://clinicaltrials.gov/study/NCT06798558