RecruitingPhase 2NCT06526299

Low PSMA SUV Boost (LPS-Boost): Intensified 177Lu-PSMA-617 Treatment for Patients With Metastatic Castrate-Resistant Prostate Cancer With Low PSMA Expressing Disease

A Phase 2 Study of Biomarker-Modulated PSMA Theranostics


Sponsor

University of Washington

Enrollment

51 participants

Start Date

Apr 29, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This phase II trial tests how well 177Lu-PSMA-617 works in treating patients with prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic) and that remains despite treatment (resistant). Lutetium Lu 177 (177Lu), the radioactive (tracer) component being delivered by prostate-specific membrane antigen (PSMA)-617, has physical properties that make it ideal radionuclide (imaging tests that uses a small dose tracer) for treatment of metastatic castrate-resistant prostate cancer (mCRPC). 177Lu-PSMA-617 works by binding to prostate cancer cells and inducing damage to deoxyribonucleic acid (DNA) inside prostate cancer cells. Giving 177Lu-PSMA-617 may improve treatment outcomes for patients with mCRPC.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether giving a higher, more intensive dose of a radioactive drug called lutetium-177 PSMA-617 can improve outcomes for men with metastatic castrate-resistant prostate cancer (mCRPC) whose tumors show relatively low uptake of the PSMA tracer on a specialized PET scan. Standard lutetium-PSMA therapy tends to be less effective when tumors absorb less of the radioactive drug. **You may be eligible if...** - You are a man aged 18 or older with confirmed prostate cancer that has spread and is no longer responding to hormone therapy - Your PSMA PET scan shows cancer spread but with a lower than average whole-body tumor signal (SUVmean below 10) - You have previously received at least one androgen receptor pathway inhibitor (such as enzalutamide or abiraterone) - Your cancer continues to progress despite treatment - Your blood counts and organ function meet the required levels **You may NOT be eligible if...** - You have previously received lutetium-PSMA therapy or other radioactive treatments (e.g., radium-223) - You have recent (within 30 days) systemic cancer treatment - You have symptomatic spinal cord compression - You have uncontrolled heart failure or significant co-existing medical conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiospecimen Collection

Undergo blood sample collection

PROCEDUREBone Scan

Undergo bone scan

PROCEDUREComputed Tomography

Undergo SPECT/CT and CT

DRUGLutetium Lu 177 Vipivotide Tetraxetan

Given IV

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

PROCEDUREPSMA PET-CT Scan

Undergo PSMA PET/CT

OTHERQuestionnaire Administration

Ancillary studies

PROCEDURESingle Photon Emission Computed Tomography

Undergo SPECT/CT


Locations(3)

University of California San Francisco

San Francisco, California, United States

Olive View-University of California Los Angeles Medical Center

Sylmar, California, United States

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States

View Full Details on ClinicalTrials.gov

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NCT06526299


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