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Phase I dose-escalation study of fractionated dose 177Lu-PSMA-617 for progressive metastatic castration resistant prostate cancer

Clinical Trial Details

This clinical trial is for men with advanced prostate cancer.

The purpose of this study is to find the highest dose level of the study drug, 177Lu-PSMA-617 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.

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 8 visits over approximately 12 weeks. 

The study medication is called 177Lu-PSMA-617, and participants will receive an infusion of the study drug 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.

Contact

Lauren Emmerich
guonc@med.cornell.edu
212-746-1480

Primary Investigator

Scott T. Tagawa, M.D.

Protocol ID(s)

Weill Cornell Medicine IRB #:

1609017542

ClinicalTrials.gov:

NCT03042468

Status:

Open to Enrollment

Age Group

Adult

Disease

Drug/Device

Drug

Study Type

Phase

1