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

NCT05691465 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-05-15

No results posted yet for this study

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.

Conditions

  • Metastatic Prostate Adenocarcinoma With Neuroendocrine Differentiation
  • Metastatic Prostate Neuroendocrine Carcinoma
  • Metastatic Prostate Small Cell Neuroendocrine Carcinoma
  • Stage IV Prostate Cancer AJCC v8

Interventions

PROCEDURE

Biospecimen Collection

Undergo collection of blood

PROCEDURE

Computed Tomography

Undergo CT scan

RADIATION

Gallium Ga 68-DOTATATE

Given IV

DRUG

Lutetium Lu 177 Dotatate

Given IV

PROCEDURE

Positron Emission Tomography

Undergo PET

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • John M Floberg · JHU Sidney Kimmel Comprehensive Cancer Center LAO

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-27
Primary Completion
2026-11-02
Completion
2026-11-02
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05691465 on ClinicalTrials.gov