ASCO GU 2025: Real World Outcomes of 177Lu-PSMA-617 in a Racially Diverse Cohort of Patients with Metastatic Castration Resistant Prostate Cancer (mCRPC)

(UroToday.com) The 2025 American Society of Clinical Oncology Genitourinary (ASCO GU) cancers symposium held in San Francisco, CA was host to the Poster Session A: Prostate Cancer. Dr. Margo Gerke presented Abstract 97: Real world outcomes of 177Lu-PSMA-617 in a racially diverse cohort of patients with metastatic castration resistant prostate cancer (mCRPC).


¹⁷⁷Lu-PSMA-617 is approved for the treatment of mCRPC based on the VISION trial. However, despite enrolling patients across 84 centers in nine countries in North America and Europe, the trial had limited racial diversity with only 6.6% total enrollment of Black or African-American patients.1 This study aimed to evaluate real-world outcomes of ¹⁷⁷Lu-PSMA-617 in a racially diverse cohort and identify patient characteristics predictive of clinical response.

They conducted a retrospective analysis of patients with mCRPC treated with ¹⁷⁷Lu-PSMA-617 at Emory Winship Cancer Institute between 2022 and 2025. The primary endpoints were progression-free survival (PFS), overall survival (OS), and PSA reduction ≥50% (PSA50). Univariate survival analysis and logistic regression were used to assess associations with clinical outcomes.

Dr. Gerke and colleagues analyzed a total of 84 patients with PSMA PET–positive mCRPC treated with ¹⁷⁷Lu-PSMA-617. Among them, 47.6% identified as Caucasian and 42.9% as Black, making this a racially diverse cohort. The median age was 71.5 years (IQR: 64–77.5), and 35.6% had grade group 5 disease. Patients had a median of five prior lines of therapy (range: 4–7), with 98.8% having received novel hormonal agents and 84.5% prior taxane treatment. Using the CHAARTED criteria, 84.5% were classified as having high-volume disease. Moreover, the median baseline PSA was 105.5 (IQR: 20.4–454.8), and the median ALP was 103.5 (IQR: 72–177.5).

The cohort completed a median of four cycles of ¹⁷⁷Lu-PSMA-617, with 35.7% completing all six cycles. The overall 12-month survival rate was 84.4%, with a survival rate of 88.3% in the white cohort compared to 81.4% in the non-white cohort (Log rank p=0.4869). The Kaplan-Meier estimates of OS are shown below.

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The median PFS for the overall cohort was six months, with a 12-month PFS rate of 41.9%. The 12-month PFS rate was similar between groups, at 42.7% in the non-white cohort and 41.5% in the white cohort

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A PSA50 response was observed in 50.0% of the overall cohort, with a higher response in the non-white cohort (56.1%) compared to the white cohort (43.9%), though this difference was not statistically significant (p=0.377).

Notably, a net decline in BMI during treatment was associated with a 56% increased risk of mortality (OS HR 1.56, CI 1.18–2.06, p<0.002)

Dr. Gerke concluded their poster presentation by sharing future directions for research:

  • Further research is needed to determine the impact of social factors on 177Lu-PSMA-617 outcomes
  • Lack of prognostic and clinically available biomarkers highlights the need to identify markers predictive of 177 Lu-PSMA-617 response
  • Quantification of SUV mean in relation to patient outcomes may improve 177Lu-PSMA-617 prognostication and personalized medicine 

Presented by: Margo Gerke, Medical Student at The Johns Hopkins University, Baltimore, Maryland, USA.

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. 

References:

  1. Sartor O, de Bono J, Chi KN, Fizazi K, Herrmann K, Rahbar K, Tagawa ST, Nordquist LT, Vaishampayan N, El-Haddad G, Park CH, Beer TM, Armour A, Pérez-Contreras WJ, DeSilvio M, Kpamegan E, Gericke G, Messmann RA, Morris MJ, Krause BJ; VISION Investigators. Lutetium-177-PSMA-617 for Metastatic Castration-Resistant Prostate Cancer. N Engl J Med. 2021 Sep 16;385(12):1091-1103. doi: 10.1056/NEJMoa2107322. Epub 2021 Jun 23. PMID: 34161051; PMCID: PMC8446332.