RecruitingPhase 2NCT05691465

Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells

A Phase II Study of Lutetium Lu 177 Dotatate in Metastatic Prostate Cancer With Neuroendocrine Differentiation


Sponsor

National Cancer Institute (NCI)

Enrollment

30 participants

Start Date

Dec 27, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This phase II trial studies how well lutetium Lu 177 dotatate works in treating patients with prostate cancer with neuroendocrine differentiation that has spread to other places in the body (metastatic). Neuroendocrine differentiation refers to cells that have traits of both hormone-producing endocrine cells and nerve cells. These cells release hormones into the blood in response to a signal from the nervous system. Hormones are biological substances that circulate through the bloodstream to control the activity of other organs or cells in the body. Lutetium Lu 177-dotatate is a radioactive drug. It binds to a protein called somatostatin receptor, which is found on some neuroendocrine tumor cells. Lutetium Lu 177-dotatate builds up in these cells and gives off radiation that may kill them. It is a type of radioconjugate and a type of somatostatin analog. Treatment with Lutetium Lu 177 dotatate may shrink the tumor in a way that can be measured in patients with metastatic prostate cancer with neuroendocrine differentiation.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests lutetium-177 dotatate (a targeted radioactive treatment) in people with metastatic prostate cancer that has developed neuroendocrine features — a type of aggressive prostate cancer that doesn't respond well to hormonal therapy and has limited treatment options. **You may be eligible if...** - You are 18 or older - You have metastatic prostate cancer with neuroendocrine characteristics, confirmed by biopsy or molecular testing, or by specific lab findings - You are in reasonable physical health (ECOG 0–2) - Your blood counts, kidney, and liver function meet minimum thresholds - Prior chemotherapy for prostate cancer is allowed, as is having had no prior chemotherapy **You may NOT be eligible if...** - Your prostate cancer does not have neuroendocrine features - Your organ function is significantly impaired - You are pregnant or unwilling to use contraception - You have had certain specific prior treatments that would disqualify you per protocol criteria 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 collection of blood

PROCEDUREComputed Tomography

Undergo CT scan

RADIATIONGallium Ga 68-DOTATATE

Given IV

DRUGLutetium Lu 177 Dotatate

Given IV

PROCEDUREPositron Emission Tomography

Undergo PET


Locations(13)

City of Hope Comprehensive Cancer Center

Duarte, California, United States

Los Angeles General Medical Center

Los Angeles, California, United States

USC / Norris Comprehensive Cancer Center

Los Angeles, California, United States

University of California Davis Comprehensive Cancer Center

Sacramento, California, United States

Northwestern University

Chicago, Illinois, United States

University of Kentucky/Markey Cancer Center

Lexington, Kentucky, United States

Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, Maryland, United States

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas, United States

M D Anderson Cancer Center

Houston, Texas, United States

University of Wisconsin Carbone Cancer Center - Eastpark Medical Center

Madison, Wisconsin, United States

University of Wisconsin Carbone Cancer Center - University Hospital

Madison, Wisconsin, United States

View Full Details on ClinicalTrials.gov

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NCT05691465


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