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Your patients with metastatic castration-resistant prostate cancer (mCRPC) are invited to join ECLIPSE

Participating in this 177Lu-PSMA-I&T trial presents an investigational therapy option for your patients that may help advance innovation in mCRPC treatment

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Hear more about this ground-breaking trial

In this 15-minute podcast, Sakir Mutevelic, MD, MSc, Curium’s chief medical officer, discusses the ECLIPSE trial in greater detail, including eligibility criteria and how to enroll patients. In addition, he describes the role of radiopharmaceuticals in diagnosing and treating prostate cancer and a patient’s typical diagnostic journey.

Targeting PSMA can initiate cell death

PSMA (prostate-specific membrane antigen) is an attractive target because it is highly expressed on the cell surface of prostate cancer tumors1

When 177Lu-PSMA-I&T binds to the extracellular portion of PSMA, it is taken into the cell, where the radiation causes DNA damage to initiate cell death2

See 177Lu-PSMA-I&T in action

Learn more about dosing administration for 177Lu‑PSMA‑I&T

Purpose

The purpose of this study is to compare the safety and efficacy of 177Lu-PSMA-I&T versus standard-of-care hormone therapy in patients with metastatic castration-resistant prostate cancer.

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Study design

A multicenter, open-label, randomized phase 3 trial comparing the safety and efficacy of 177Lu-PSMA-I&T versus hormone therapy in patients with metastatic castration-resistant prostate cancer, previously treated with only one ARAT and are taxane-based chemonaive.

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Click below to expand content

  • Radiographic progression-free survival

  • Overall survival
  • Second radiographic progression
  • Progression-free survival (PFS, composite)
  • Progression-free survival 2 (PFS2, composite)
  • PSA50 response rate
  • Impact on skeletal symptoms
  • Change in use of chemotherapy
  • Quality of life
  • Safety

  • Objective response rate
  • Disease control rate
  • Time to PSA progression
  • Duration of response
  • Pharmacokinetics and dosimetry

Patients will be randomized using a 2:1 ratio of study medication to standard of care

This trial is a crossover study in which those patients randomized to the standard-of-care arm may have the option to receive the study drug if disease progression is detected while on standard-of-care hormone therapy.

The typical patient journey and the potential path to 177Lu‑PSMA‑I&T therapy

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Patients may follow similar paths, yet every treatment journey is different. Your patients may qualify for this trial; however, specific requirements will need to be met.

Major inclusion criteria

  • Males, 18 years or older
  • Proven metastatic castration-resistant prostate cancer
  • Progressive disease while on androgen receptor-axis-targeted (ARAT) therapy (abiraterone, enzalutamide, darolutamide, apalutamide)
  • Positive PSMA PET scan

Major exclusion criteria

  • Previous treatment with more than one ARAT
  • Previous treatment with chemotherapy in the castration-resistant setting
  • Previous treatment with other radioligand therapy

Contact eclipse@curiumpharma.com for a full list of inclusion and exclusion criteria

Directory of ECLIPSE trial sites across the United States

Please contact these sites directly for more information about eligibility

Click on a state below to see trial sites and primary investigators

  • Arizona Institute of Urology (AIU) - Tucson

    Kalpesh Patel, MD

  • Saint John’s Cancer Institute - Santa Monica

    Przemyslaw Twardowski, MD

  • Providence Medical Foundation - Fullerton

    Sanjay Sharma, MD

  • Hoag Family Cancer Institute - Laguna Beach

    Gary Ulaner, MD

  • University of California San Francisco (UCSF) Medical Center

    Vadim Koshkin, MD

  • San Francisco VA

    Franklin Huang, MD, PhD

  • MemorialCare - Long Beach

    Amol Rao, MD

  • Biogenix Molecular - Miami

    Frankis Almaguel, MD, PhD

  • GenesisCare USA - Boca Raton

    Vinay Sharma, MD

  • GenesisCare USA - Plantation

    Christopher Chen, MD

  • Florida Urology Partners - Tampa

    Alexander Engelman, MD

  • Orlando Health - Orlando

    Daniel Landau, MD

  • Northwestern Memorial - Chicago

    David James VanderWeele, MD, PhD

  • NorthShore Kellogg Cancer Center - Evanston

    Daniel Shevrin, MD

  • Johns Hopkins

    Steven Rowe, MD, PhD

  • Mid-Atlantic Permanente Research Institute - Gaithersburg

    Philipose Mulugeta, MD

  • GenesisCare USA - Troy

    Tom Boike, MD

  • BAMF Health - Grand Rapids

    Brandon Mancini, MD, MBA, FACRO

  • Henry Ford Health System

    Clara Hwang, MD

  • Michigan Institute of Urology (MIU) - Troy

    Jason Hafron, MD

  • M Health Fairview

    Gautam Jha, MD

  • Saint Louis University School of Medicine

    Razi Muzaffar, DO

  • Nebraska Cancer Specialists

    Ralph Hauke, MD, FACP

  • GU Research Network - Omaha

    Luke Nordquist, MD, FACP

  • Rutgers University Medical Center - New Brunswick

    Tina Mayer, MD

  • Columbia University Medical Center/Herbert Irving Pavilion

    Mark Stein, MD

  • Mt Sinai Hospital

    Munir Ghesani, MD

  • SUNY Upstate - Syracuse

    Gennady Bratslavsky, MD

  • Central Ohio Urology - Columbus

    Benjamin Martin, MD

  • The Urology Group - Cincinnati

    Marc Pilskin, DO

  • SSM Health Oklahoma City (Hightower Clinical) - Oklahoma City

    David Lam, MD

  • Oregon Health & Science University (OHSU)

    Jacqueline Vuky, MD

  • VA Portland

    Julie Graff, MD

  • MidLantic Urology - Bala Cynwyd

    Laurence Belkoff, DO, MSc, FACOS

  • Urology San Antonio

    Daniel Saltzstein, MD

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References: 1. Hupe MC, Philippi C, Roth D, et al. Expression of prostate-specific membrane antigen (PSMA) on biopsies is an independent risk stratifier of prostate cancer patients at time of initial diagnosis. Front Oncol. 2018;8:623. doi:10.3389/fonc.2018.00623 2. Ruigrok EAM, van Vliet N, Dalm SU, et al. Extensive preclinical evaluation of lutetium-177-labeled PSMA-specific tracers for prostate cancer radionuclide therapy. Eur J Nucl Med Mol Imaging. 2021;48(5):1339-1350. doi:10.1007/s00259-020-05057-6

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