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Clinical trialNCT05691465RecruitingPhase 2Interventional

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

SponsorNational Cancer Institute (NCI)Enrollment35Metastatic Prostate Adenocarcinoma With Neuroendocrine DifferentiationMetastatic Prostate Neuroendocrine CarcinomaMetastatic Prostate Small Cell Neuroendocrine CarcinomaStage IVB Prostate Cancer AJCC v8
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

13 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • City of Hope Comprehensive Cancer Center

    Duarte, California, United States

    Abhishek Tripathi
    Recruiting
  • Los Angeles General Medical Center

    Los Angeles, California, United States

    Jacek Pinski
    Recruiting
  • Usc / Norris Comprehensive Cancer Center

    Los Angeles, California, United States

    Jacek Pinski
    Recruiting
  • University of California Davis Comprehensive Cancer Center

    Sacramento, California, United States

    Active, not recruiting
  • Northwestern University

    Chicago, Illinois, United States

    Maha H. Hussain
    Recruiting
  • University of Kentucky/markey Cancer Center

    Lexington, Kentucky, United States

    Zin W. Myint
    Recruiting
  • Johns Hopkins University/sidney Kimmel Cancer Center

    Baltimore, Maryland, United States

    Michael A. Carducci
    Recruiting
  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, United States

    Michael McCormack
    Recruiting
  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, United States

    Edmund Folefac
    Recruiting
  • Ut Southwestern/simmons Cancer Center-Dallas

    Dallas, Texas, United States

    Suspended
  • Ut Md Anderson Cancer Center

    Houston, Texas, United States

    Ana Aparicio
    Recruiting
  • University of Wisconsin Carbone Cancer Center - Eastpark Medical Center

    Madison, Wisconsin, United States

    John M. Floberg
    Recruiting
  • University of Wisconsin Carbone Cancer Center - University Hospital

    Madison, Wisconsin, United States

    John M. Floberg
    Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
27 Dec 2023
Primary completion
2 Nov 2026
Completion
2 Nov 2026
Last update posted
14 Jul 2026
Registered enrollment
35
Registry id
NCT05691465

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.