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Radioisotope Therapy

177Lu-PSMA-617 for Prostate Cancer

Phase 1 & 2
Waitlist Available
Led By Scott Tagawa, MD
Research Sponsored by Weill Medical College of Cornell University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have normal organ and marrow function as defined below: Absolute neutrophil count >2,000 cells/mm3, Hemoglobin ≥9 g/dL, Platelet count >150,000 x 109/uL, Serum creatinine <1.5 x upper limit of normal (ULN) or calculated creatinine clearance ≥ 60 mL/min/1.73 m2 by Cockcroft-Gault, Serum total bilirubin <1.5 x ULN (unless due to Gilbert's syndrome in which case direct bilirubin must be normal, Serum AST and ALT <1.5 x ULN, Ability to understand and the willingness to sign a written informed consent document
Documented progressive metastatic CRPC based on Prostate Cancer Working Group 3 (PCWG3) criteria, which includes at least one of the following criteria: PSA progression, Objective radiographic progression in soft tissue, New bone lesions
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial is testing a new drug to treat prostate cancer. The goal is to see what is the highest dose that can be given without severe side effects.

Who is the study for?
This trial is for adults over 18 with advanced prostate cancer that's spreading and getting worse despite low testosterone levels and previous treatments like enzalutamide or taxane chemotherapy. Participants must have good organ function, no brain metastases, not be on certain bone medications recently, and agree to use birth control if they can have children.Check my eligibility
What is being tested?
The study is testing different doses of a drug called 177Lu-PSMA-617 to find the highest dose that doesn't cause severe side effects in men with progressive metastatic CRPC (a type of prostate cancer). The drug targets cancer cells using a radioactive substance linked to a molecule that binds to PSMA receptors on tumors.See study design
What are the potential side effects?
Possible side effects from the treatment may include nausea, fatigue, dry mouth, changes in blood counts leading to increased risk of infections or bleeding. There might also be kidney damage due to the radioactivity as well as potential radiation exposure-related risks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My prostate cancer is worsening, shown by rising PSA levels, new bone lesions, or growth in scans.
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I can take care of myself and perform daily activities.
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My prostate cancer was confirmed by a lab test.
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My testosterone levels are below 50 ng/dL, and I am on hormone therapy unless I've had an orchiectomy.
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I am older than 18 years.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Subjects That Achieved Cumulative Maximum Tolerated Dose (MTD) Phase II Dose of 177Lu-PSMA-617
Number of Subjects With Dose Limiting Toxicity (DLT) of Fractionated Dose of 177Lu-PSMA-617
Recommended Phase II Dose of 177Lu-PSMA-617 in a 2-week Dose-fractionation Regimen
Secondary outcome measures
Count of Participants That Experience an Adverse Event
Count of Patients That Had a Radiographic Response Rate Measured by RECIST 1.1 With PCWG3 Modifications
Number of CTC Count Responders
+3 more
Other outcome measures
Disease assessment with 68Ga-PSMA-HBED-CC PET/CT prior to and following investigational treatment
Genomic DNA repair pathways in relationship to outcome following fractionated dose 177Lu-PSMA-617 by collecting archival pathology tissue.
Patient reported outcomes using Functional Assessment Cancer Therapy-Prostate
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: All subjectsExperimental Treatment2 Interventions
177Lu-PSMA-617 [50mCi (1.85GBq) - 300mCi (11.1GBq)] intravenous X2 doses, 2 weeks apart (Visit 1 and 2) 68Ga-PSMA-HBED-CC [5 ±2mCi or 185 ±74MBq] intravenous during screening and at 12 weeks with standard imaging
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
68Ga-PSMA-HBED-CC
2017
Completed Phase 2
~20
177Lu-PSMA-617
2018
Completed Phase 3
~840

Find a Location

Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor
1,059 Previous Clinical Trials
1,316,093 Total Patients Enrolled
48 Trials studying Prostate Cancer
34,561 Patients Enrolled for Prostate Cancer
Scott Tagawa, MDPrincipal InvestigatorWeill Medical College of Cornell University
7 Previous Clinical Trials
199 Total Patients Enrolled
6 Trials studying Prostate Cancer
179 Patients Enrolled for Prostate Cancer
~6 spots leftby Jun 2025
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