RecruitingPhase 1Phase 2NCT04868604

64Cu-SAR-bisPSMA and 67Cu-SAR-bisPSMA for Identification and Treatment of PSMA-expressing Metastatic Castrate Resistant Prostate Cancer (SECuRE)

A Phase I/IIa Theranostic Study of 64Cu-SAR-bisPSMA and 67Cu-SAR-bisPSMA for Identification and Treatment of PSMA-expressing Metastatic Castrate Resistant Prostate Cancer


Sponsor

Clarity Pharmaceuticals Ltd

Enrollment

54 participants

Start Date

Aug 11, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

The aim of this study is to determine the safety and efficacy of 67Cu-SAR-bisPSMA in participants with PSMA-expressing metastatic castrate resistant prostate cancer.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests a new radioactive treatment for advanced prostate cancer that has stopped responding to hormone therapy. The treatment uses a radioactive copper compound that finds and attaches to a protein called PSMA, which is found on prostate cancer cells, then delivers radiation directly to tumors throughout the body. **You may be eligible if...** - You are 18 or older with confirmed, spread prostate cancer that no longer responds to hormone-lowering therapy - Your cancer showed PSMA activity on a special PET scan - Your testosterone levels are at castrate levels (very low) - You have previously tried at least one advanced hormone therapy drug (such as enzalutamide or abiraterone) - Your cancer is still progressing despite treatment (rising PSA, new lesions, or new bone involvement) - Your overall health status is acceptable (ECOG 0–2) with life expectancy over 6 months **You may NOT be eligible if...** - You have not tried any advanced hormone therapy - Your cancer has not shown clear signs of progression - You have serious kidney, liver, or bone marrow problems - You are unwilling to follow contraception requirements during the study 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

DRUG64Cu-SAR-bisPSMA

64Cu-SAR-bisPSMA

DRUG67Cu-SAR-bisPSMA

67Cu-SAR-bisPSMA


Locations(7)

Stanford Cancer Institute

Stanford, California, United States

East Jefferson General Hospital

River Ridge, Louisiana, United States

BAMF Health

Grand Rapids, Michigan, United States

Mayo Clinic

Rochester, Minnesota, United States

Washington University School of Medicine at Barnes-Jewish Hospital

St Louis, Missouri, United States

XCancer

Omaha, Nebraska, United States

Weill Cornell Medicine at New York-Presbyterian

New York, New York, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT04868604


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