(UroToday.com) The 2025 American Society of Clinical Oncology Genitourinary (ASCO GU) cancers symposium held in San Francisco, CA between February 13th and 15th 2025, was host to the Trials in Progress Poster Session A: Prostate Cancer. Dr. Oliver Sartor presented the trial in progress poster 294: Long-term safety outcomes of 177Lu‑PSMA-617 in patients with prostate cancer.
The approval of ¹⁷⁷Lu-PSMA-617 for adult patients with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) previously treated with androgen receptor pathway inhibitors and taxane-based chemotherapy was based on the Phase 3 VISION study (NCT03511664). Notably, this study demonstrated that adding ¹⁷⁷Lu-PSMA-617 to standard of care prolonged both radiographic progression-free survival and overall survival in patients with advanced PSMA-positive mCRPC.1
Further characterization of long-term safety outcomes in ¹⁷⁷Lu-PSMA-617–treated patients is essential, particularly regarding potential treatment-related risks. To address this, the long-term follow-up (LTFU) safety study (NCT05803941) has been established. Findings from this study will be crucial for assessing delayed toxicities in patients with PSMA-positive metastatic prostate cancer treated with ¹⁷⁷Lu-PSMA-617 globally.
The LTFU study is a prospective, multi-center, post-authorization safety study. Dr Sartor noted that this study is a post-marketing requirement by the US Food and Drug Administration (FDA). Adult patients with prostate cancer who received ≥1 dose of ¹⁷⁷Lu-PSMA-617 within one of the prospective parent studies mentioned in the table below would be eligible.
Patients may enroll in the LTFU study after completing the requirements of their parent study. The follow-up period extends up to 10 years from the first dose of ¹⁷⁷Lu-PSMA-617 to the patient's last follow-up.
Following enrollment, patients will undergo baseline assessments, followed by evaluations every 6–8 months for up to 10 years after their first dose of ¹⁷⁷Lu-PSMA-617 or until death. Data collection will include physical and laboratory assessments, concomitant medications, and other anticancer therapies.
Study endpoints and assessments are clearly described below:
Interim analyses are planned at 2- and 5-years post-study activation. The trial began on August 14, 2023, and enrollment is ongoing (n=18) across 62 sites in Europe, North America, and Asia.
Presented by: Oliver Sartor, MD, Medical oncologist in the Division of Medical Oncology in the Department of Oncology at Mayo Clinic in Rochester, Minnesota. Chair of the Genitourinary Cancer Disease Group and Director of Radiopharmaceutical Clinical Trials across the enterprise for Mayo Clinic Comprehensive Cancer Center.
Written by: Julian Chavarriaga, MD – Urologic Oncologist at Cancer Treatment and Research Center (CTIC) via Society of Urologic Oncology (SUO) Fellow at The University of Toronto. @chavarriagaj on Twitter during the 2025 Genitourinary (GU) American Society of Clinical Oncology (ASCO) Annual Meeting, San Francisco, CA, Thurs, Feb 13 – Sat, Feb 15, 2025.
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