RecruitingPhase 1NCT04597411

Study of 225Ac-PSMA-617 in Men With PSMA-positive Prostate Cancer

AcTION: A Phase I Study of [225Ac]Ac-PSMA-617 in Men With PSMA-positive Prostate Cancer With or Without Prior [177Lu]Lu-PSMA-617 Radioligand Therapy


Sponsor

Endocyte

Enrollment

99 participants

Start Date

Apr 1, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

This is a Phase 1, open-label, international, dose escalation study to evaluate the safety of \[225Ac\]Ac-PSMA-617 (225Ac-PSMA-617) in men with PSMA-positive prostate cancer who have and have not had prior exposure to \[177Lu\]Lu-PSMA-617 (177Lu-PSMA-617) or \[177Lu\]Lu-PSMA I\&T (177Lu-PSMA I\&T).


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests actinium-225 (225Ac-PSMA-617), a radioactive drug that targets a protein found on prostate cancer cells called PSMA. It delivers radiation directly to the cancer cells. The study is for men with prostate cancer that has stopped responding to other treatments and whose cancer is confirmed to express PSMA on a special PET scan. **You may be eligible if...** - You are 18 or older with a confirmed prostate cancer diagnosis - A PSMA PET scan done within the last 28 days shows your cancer is PSMA-positive - Your overall health/functional status is adequate (ECOG 0–2) - Your organ function (liver, kidneys, bone marrow) meets study requirements **You may NOT be eligible if...** - Your PET scan shows areas of PSMA-negative disease (meaning the cancer doesn't have enough of the target protein in certain areas) - You have specific types of PSMA-negative metastases above a certain size - You do not meet organ function requirements 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

RADIATION225^Ac-PSMA-617

administered intravenously under the dose escalation schedule

RADIATION68^Ga-PSMA-11

administered intravenously at a dose of 111 - 185 MBq (3 - 5 mCi)


Locations(2)

St. Vincent's Hospital Research Office-Translational Research Center

Darlinghurst, Australia

Steve Biko Hospital-Department of Nuclear Medicine

Pretoria, South Africa

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NCT04597411


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