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Radioactive Drug

177Lu-PSMA-617 for Prostate Cancer

Phase 2
Recruiting
Led By Jeremie Calais, MD
Research Sponsored by Jonsson Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed approximately at 2 years
Awards & highlights

Summary

This trial is testing the effectiveness of re-treating patients with metastatic castration-resistant prostate cancer using a radioactive drug called 177Lu-PSMA-617. This drug targets a protein found in

Who is the study for?
This trial is for men with prostate cancer that has spread beyond the original site and doesn't respond to hormone therapy or surgery. Participants must have had a good response to initial treatment with a radioactive drug called 177Lu-PSMA-617.
What is being tested?
The study is testing if giving patients more doses of the radioactive drug 177Lu-PSMA-617 can help improve survival and disease outcomes in those who previously responded well to this treatment. It includes scans and tests to monitor effects.
What are the potential side effects?
Possible side effects include radiation exposure risks, fatigue, dry mouth, nausea, changes in blood counts leading to increased infection risk or bleeding problems, kidney damage, and other potential organ-specific issues.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed approximately at 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed approximately at 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
12-month overall survival
Secondary study objectives
Biochemical progression-free survival (PFS)
Bone Pain
Changes in health-related quality of life_ Eastern Cooperative Oncology Group score
+7 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (177Lu-PSMA-617)Experimental Treatment7 Interventions
Patients receive 177Lu-PSMA-617 IV on day 1 of each cycle. Treatment repeats every 6 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive gallium Ga 68 gozetotide IV and undergo PET/CT at screening and on study, undergo SPECT/CT on study, and undergo collection of blood samples throughout the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Positron Emission Tomography
2011
Completed Phase 2
~2200
Biospecimen Collection
2004
Completed Phase 3
~2020
Computed Tomography
2017
Completed Phase 2
~2740
Single Photon Emission Computed Tomography
2008
Completed Phase 4
~310

Find a Location

Who is running the clinical trial?

Jonsson Comprehensive Cancer CenterLead Sponsor
369 Previous Clinical Trials
29,389 Total Patients Enrolled
39 Trials studying Prostate Cancer
3,982 Patients Enrolled for Prostate Cancer
Novartis PharmaceuticalsIndustry Sponsor
2,891 Previous Clinical Trials
4,202,025 Total Patients Enrolled
33 Trials studying Prostate Cancer
5,888 Patients Enrolled for Prostate Cancer
Jeremie Calais, MDPrincipal InvestigatorUCLA / Jonsson Comprehensive Cancer Center
5 Previous Clinical Trials
142 Total Patients Enrolled
1 Trials studying Prostate Cancer
30 Patients Enrolled for Prostate Cancer
~27 spots leftby Jan 2026
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