[WCG-IAA] A Multi-Center, Open-Label, Randomized Phase 3 Trial Comparing the Safety and Efficacy of 177-Lu-PSMA-I&T versus Hormone Therapy in Patients with Metastatic Castration-Resistant Prostate Cancer (ECLIPSE)

Principal Investigator

Alexandra Sokolova

Study Purpose

The purpose of this study is to investigate the safety and efficacy of the study drug (Lutetium-177 PSMA I&T) in participants with metastatic castration-resistant prostate cancer (mCRPC), and to find out what effects this study drug has on participants and their prostate cancer. The study drug is targeted to act on certain prostate cancer cells that have a protein called prostate specific membrane antigen (PSMA) on their surface.

Medical Condition(s)

Metastatic castration-resistant prostate cancer (mCRPC)

Eligibility Criteria

- Must have histologically or pathologically confirmed prostate adenocarcinoma without predominant small cell component
- Must have progressive disease by one or more criteria
- Must have had previous treatment with next-generation androgen receptor-directed therapy (e.g. abiraterone, enzalutamide, apalutamide, darolutamide)
- Must be PSMA-positive as determined by PSMA-PET scan
- Must be effectively castrate and plan to continue with chronic medical or surgical castration

- Must not have had prior treatment with radioligand therapy
- Must not have had prior treatment with radium-223 in the past 12 weeks before joining the study
- Must not have had prior chemotherapy for castration-sensitive or castration-resistant prostate cancer (e.g. docetaxel or cabazitaxel)

Age Range

18 - NA

Healthy Volunteers Needed


Duration of Participation

Participation may last up to approximately 10 months. The investigator and study staff may continue to follow your cancer progression for this study for up to 5 years.

Minors Included



Clinical Trials Information Line: Phone 503-494-1080 or


Curium US LLC

Recruitment End


Compensation Provided


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