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Multi-Center, Open-Label, Randomized Phase 3 Trial Comparing the Safety and Efficacy of Lu-PSMA-I&T versus Hormone Therapy in Patients with Metastatic Castration-Resistant Prostate Cancer
Overall Recruitment Status: Active, currently enrolling
 
Official Title
Multi-Center, Open-Label, Randomized Phase 3 Trial Comparing the Safety and Efficacy of Lu-PSMA-I&T versus Hormone Therapy in Patients with Metastatic Castration-Resistant Prostate Cancer
 
Region Sponsors
Mid-Atlantic
Curium US LLC
 
Acronym KP IRB No.
ECLIPSE 1844828
 
Study Type Phase
Clinical Trial Phase III
 
Study Population Description
Men with metastatic Castration-Resistant Prostate Cancer.
 
Purpose
This is a prospective, open-label, multi-center, randomized, Phase 3 study evaluating Lutetium 177Lu-PSMA-I&T as treatment compared to standard of care hormone therapy in men with metastatic Castration-Resistant Prostate Cancer.
 
Detailed Description
 
Gender Age Limit
Male
 
Inclusion Criteria
  • Histologically or pathologically confirmed prostate adenocarcinoma without predominant small cell component.
  • Progressive disease by one or more of the following criteria: Serum/plasma PSA progression defined as 2 consecutive increases in PSA over a previous reference value measured at least 1 week apart with a minimum start value of >2 ng/mL, and/or progression of measurable disease (RECIST 1.1) or presence of at least two new bone lesions (PCWG3 criteria).
  • Must have received no more than one previous AR-directed therapy. Must have been administered ARAT (abiraterone, enzalutamide, darolutamide, or apalutamide) in the castration-sensitive or castration-resistant setting.
  • Must have progressed while on ARAT.
  • PSMA-PET scan (e.g., 68Ga-PSMA-11 or 18F-DCFPyL) positive as determined by central reader.
  • Effective castration with serum testosterone level of <50 ng/dL and plan to continue with chronic medical or surgical castration.
 
Exclusion Criteria
  • Prior treatment with radioligand therapy including other lutetium-labeled compounds.
  • Prior treatment with radium-223 (Xofigo) within the past 12 weeks. Prior chemotherapy treatment for castration-sensitive or castration-resistant prostate cancer (docetaxel or cabazitaxel).
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) = 2
  • Patients with known HRR gene-mutation who have not been previously treated with olaparib or rucaparib.
  • Other concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy, or investigational therapy.
  • Inadequate organ and bone marrow function

 
Keywords and/or Specific Medical Conditions
  • Oncology (Adult)
 
KP Clinical Facility
  • Gaithersburg Medical Center
 
Clinical Area
  • Oncology (Adult)


Principal Investigator:
Philipose Mulugeta, MD
Contact Information:


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