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Upstate Active Clinical Trials

Study Title:

CURLu177PSM0001 - A Multi-Center, 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 (ECLIPSE)

What is the purpose of the study? (in Layman's terms, please describe the study)

To prospectively assess the efficacy of 177Lu-PSMA-I&T on the improvement of radiographic
progression-free survival (rPFS) as determined by PCWG3-modified RECIST 1.1 in men with
metastatic Castration-Resistant Prostate Cancer (mCRPC) compared to standard of care
hormone therapy.

Upstate Institutional Review Board (IRB) Number:

1904875

Study/Protocol ID:

CURLu177PSM0001

Study Phase:

III

Patient Age Group:

Adults

Principal Investigator:

Gennady Bratslavsky, MD

What is involved if I participate?

  • How long is the study?
    Participation may last up to approximately 10 months or possibly longer depending upon how your cancer progresses. Your study doctor will discuss with you if your participation will last longer than approximately 10 months. Once you have completed the treatments in this study, the study doctor and staff will continue to follow your cancer progression for this study for up to five years.
  • Is transportation provided or reimbursed?
    Yes
  • Is parking provided or reimbursed?
    Yes
  • What tests and procedures are involved?
    Physical exams, blood work, ECGs, PSMA PET scan, CT scans, bone scans, questionnaires

Where will the study take place?

University Hospital, Upstate Cancer Center, Urology Clinic at 550 Harrison Center

Other Information:

If you are eligible to continue in the study, you will be randomly assigned (like flipping a coin), to receive either the study drug or the standard of care hormone therapy treatment. For every two participants receiving Lutetium-177 PSMA I&T, one participant receives standard of care treatment; that is a “2:1” ratio.

ClinicalTrials.Gov ID:

NCT05204927

For more information about this trial go to ClinicalTrials.Gov

Who can I contact for more information?

Name: Nicholas Carusone, BS
Phone: 315-464-5296
Email: carusonn@upstate.edu

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