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Phase I/II Dose−escalation Trial of Combination Fractionated-dose 177Lu−J591 and 177Lu−PSMA−617 in Patients with Metastatic Castration−resistant Prostate Cancer

Clinical Trial Details

The purpose of this study is to find the highest dose level of the combination of the two study drugs, 177Lu-PSMA-617 and 177Lu−J591 that can be given without severe side effects. The research study is being done because the standard treatments for prostate cancer that has spread beyond the prostate gland are intended to minimize the adverse effects of the disease. These treatments, however, are not curative and we hope to identify new treatments. 

Patients who choose to participate in this study will have a screening visit to determine whether or not they are eligible to participate in the study. The treatment phase is comprised of 9 visits over approximately 12 weeks. 

The study medication is the combination two study drugs, 177Lu-PSMA-617 and 177Lu−J591 and participants will receive an infusion of the study drugs on Visit 1 and Visit 3 of the study. 

During the study visits, participants will undergo routine tests and procedures, such as physical examinations, and routine blood tests. Some blood tests will be done for research purposes only, and participants will also undergo a research PET/CT scan at screening and end of study. 

After completion of therapy, participants may be contacted on a periodic basis to see how they are doing. 

Key Eligibility: 

Open to men age 18 and older
Diagnosis of progressive metastatic prostate cancer 
Have been previously treated for their disease with particular types of therapy
Detailed eligibility reviewed when you contact the study team

Study contact by location

Upper East Side - Manhattan

Contact(s)

Lauren Emmerich, RN
(212) 746-1851
lae9024@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

1802018988

ClinicalTrials.gov:

NCT03545165

Status

Open to Enrollment

Age Group

Adult

Sponsor