Actively Recruiting

Phase 2
Age: 18Years +
MALE
NCT05691465

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

Led by National Cancer Institute (NCI) · Updated on 2026-05-13

30

Participants Needed

13

Research Sites

148 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Male patients aged 18 years or older
  • Metastatic prostate cancer with neuroendocrine differentiation confirmed by biopsy or molecular features
  • Progression of visceral metastases without PSA progression or elevated neuroendocrine markers
  • ECOG performance status 0 to 2 (Karnofsky score 60% or higher)
  • Absolute neutrophil count at least 1,500/mcL
  • Platelet count at least 100,000/mcL
  • Hemoglobin level at least 8 g/dL before each treatment dose
  • Total bilirubin less than or equal to 1.5 times institutional upper limit
  • AST and ALT less than or equal to 3 times institutional upper limit
  • Creatinine clearance at least 40 mL/min
  • HIV patients on effective therapy with undetectable viral load
  • Patients with treated hepatitis B or C infection under specific conditions
  • Patients with treated brain metastases without progression
  • Patients with prior or concurrent cancers not interfering with study
  • New York Heart Association Functional Classification class 2B or better
  • Current disease progression per Prostate Cancer Working Group 3 criteria
  • Ongoing use of LHRH agonists/antagonists unless prior orchiectomy or pure neuroendocrine carcinoma
  • No concurrent anti-cancer therapies
  • Agreement to use contraception during and after study participation
  • Ability to provide informed consent
  • Positive Gallium 68 Dotatate PET scan with at least one lesion showing uptake greater than normal liver
Not Eligible

You will not qualify if you...

  • Receiving other investigational drugs
  • Allergic reaction to similar compounds as Lutetium Lu 177 dotatate
  • Use of long-acting somatostatin analogs within 4 weeks before treatment or during treatment except for carcinoid syndrome control
  • Use of short-acting somatostatin analogs within 24 hours before treatment or during treatment except for carcinoid syndrome control
  • Uncontrolled illnesses
  • Stroke, heart attack, severe angina, bypass surgery, or severe heart failure within 6 months before treatment
  • Uncontrolled high blood pressure (systolic ≥ 160 mmHg or diastolic ≥ 100 mmHg) at screening

AI-Screening

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Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 13 locations

1

City of Hope Comprehensive Cancer Center

Duarte, California, United States, 91010

Actively Recruiting

2

Los Angeles General Medical Center

Los Angeles, California, United States, 90033

Actively Recruiting

3

USC / Norris Comprehensive Cancer Center

Los Angeles, California, United States, 90033

Actively Recruiting

4

University of California Davis Comprehensive Cancer Center

Sacramento, California, United States, 95817

Active, Not Recruiting

5

Northwestern University

Chicago, Illinois, United States, 60611

Actively Recruiting

6

University of Kentucky/Markey Cancer Center

Lexington, Kentucky, United States, 40536

Actively Recruiting

7

Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, Maryland, United States, 21287

Suspended

8

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States, 27157

Actively Recruiting

9

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States, 43210

Actively Recruiting

10

UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas, United States, 75390

Suspended

11

M D Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

12

University of Wisconsin Carbone Cancer Center - Eastpark Medical Center

Madison, Wisconsin, United States, 53718

Actively Recruiting

13

University of Wisconsin Carbone Cancer Center - University Hospital

Madison, Wisconsin, United States, 53792

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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