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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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Mechanism of action

Targeting PSMA can initiate cell death

Prostate-specific membrane antigen (PSMA) 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

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
  • 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

  • O’Neal Comprehensive Cancer Center at University of Alabama at Birmingham

    Sam Galgano, MD

  • 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

  • GenesisCare USA - Boca Raton

    Vinay Sharma, MD

  • GenesisCare USA - Ft. Meyers

    Constantine Mantz, MD

  • GenesisCare USA - Plantation

    Christopher Chen, MD

  • Florida Urology Partners - Tampa

    Alexander Engelman, 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

  • University of Michigan

    Benjamin Viglianti, MD, PhD

  • University of Minnesota

    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

  • AMP Urology - Syracuse

    Neil Mariados, MD

  • Wilmot Cancer Institute (University of Rochester)

    Hong Zhang, MD, PhD

  • Central Ohio Urology - Columbus

    Benjamin Martin, MD

  • Oregon Health & Science University (OHSU)

    Tom Beer, MD, FACP

  • VA Portland

    Julie Graff, MD

  • MidLantic Urology - Bala Cynwyd

    Laurence Belkoff, DO, MSc, FACOS

  • Houston Metro Urology

    Sachin Patil, MD

  • Urology San Antonio

    Neil Parikh, 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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