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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed approximately at 2 years

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~2030