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Related Experiment Video

Updated: Jul 8, 2026

A Bioluminescent and Fluorescent Orthotopic Syngeneic Murine Model of Androgen-dependent and Castration-resistant Prostate Cancer
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LASER: A Phase 2 Trial of 177Lu-PSMA-617 as Systemic Therapy for RCC.

Shir Hazut Krauthammer1,2, Wanling Xie3, Nicole LaBrecque4

  • 1Department of Imaging, Dana-Farber Cancer Institute, Boston, Massachusetts; skrauthammer@mgb.org.

Journal of Nuclear Medicine : Official Publication, Society of Nuclear Medicine
|January 16, 2026
PubMed
Summary

This study investigates 177Lu-PSMA-617 for advanced clear cell renal cell carcinoma (ccRCC) in patients progressing after standard therapies. It evaluates safety and efficacy, aiming to establish PSMA-targeted radiopharmaceutical therapy as a new treatment option.

Keywords:
177Lu-PSMA-617PSMAclear cell renal cell carcinomaclinical trial protocolradiopharmaceutical therapy

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Area of Science:

  • Oncology
  • Radiopharmaceutical Therapy
  • Renal Cell Carcinoma Research

Background:

  • Clear cell renal cell carcinoma (ccRCC) is a prevalent and challenging malignancy, often progressing despite current treatments.
  • Prostate-specific membrane antigen (PSMA) is present in ccRCC tumor neovasculature, presenting a potential therapeutic target.
  • 177Lu-PSMA-617 is an established therapy for prostate cancer, showing promise for other PSMA-positive cancers.

Purpose of the Study:

  • To evaluate the safety and efficacy of 177Lu-PSMA-617 in patients with advanced PSMA-positive ccRCC.
  • To assess the objective response rate (ORR) as the primary endpoint.
  • To explore secondary endpoints including safety, progression-free survival (PFS), and overall survival (OS).

Main Methods:

  • A single-center, open-label, single-arm, phase 2 clinical trial.
  • Enrollment of 24 patients with advanced, PSMA-positive ccRCC who progressed after standard therapies (ICI and TKI).
  • Administration of up to 6 cycles of 177Lu-PSMA-617 every 6 weeks, with a 2-stage design for patient enrollment.

Main Results:

  • The primary endpoint is the objective response rate (ORR) per RECIST 1.1 criteria.
  • Secondary endpoints include safety assessments, progression-free survival (PFS), and overall survival (OS).
  • Exploratory objectives focus on correlating imaging biomarkers, cell-free DNA, and genomic data with outcomes.

Conclusions:

  • This prospective trial will determine the safety and preliminary efficacy of 177Lu-PSMA-617 for advanced ccRCC.
  • Results may support the development of PSMA-targeted radiopharmaceutical therapy for refractory ccRCC.
  • This approach offers a potential novel treatment avenue for patients with limited options.