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

Part of paid clinical trials in Duarte, California.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT05691465
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo collection of blood
  • Computed Tomography — PROCEDURE
    Undergo CT scan
  • Gallium Ga 68-DOTATATE — RADIATION
    Given IV
  • Lutetium Lu 177 Dotatate — DRUG
    Given IV
  • Positron Emission Tomography — PROCEDURE
    Undergo PET

Study Details

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.

Key Dates

Start date
Dec 27, 2023
Status verified
Jan 2026
Primary completion
Nov 2, 2026
Completion
Nov 2, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (lutetium Lu 177 dotatate)
    Patients receive lutetium Lu 177 dotatate IV over 30 minutes. Cycles repeat Q6W for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive gallium Ga 68-dotatate IV during screening then undergo PET/CT scan at baseline and collection of blood throughout the trial.

Primary Outcome Measure

Objective response rate (ORR) [ Time Frame: At 6 months ]

Locations (13)

FacilityCityStateZIPSite coordinators
City of Hope Comprehensive Cancer CenterDuarteCalifornia91010
Site Public Contact
[email protected]
800-826-4673
Abhishek Tripathi (PRINCIPAL_INVESTIGATOR)
Los Angeles General Medical CenterLos AngelesCalifornia90033-
USC / Norris Comprehensive Cancer CenterLos AngelesCalifornia90033-
University of California Davis Comprehensive Cancer CenterSacramentoCalifornia95817-
Northwestern UniversityChicagoIllinois60611
Site Public Contact
[email protected]
312-695-1301
Maha H. Hussain (PRINCIPAL_INVESTIGATOR)
University of Kentucky/Markey Cancer CenterLexingtonKentucky40536
Site Public Contact
859-257-3379
Zin W. Myint (PRINCIPAL_INVESTIGATOR)
Johns Hopkins University/Sidney Kimmel Cancer CenterBaltimoreMaryland21287
Site Public Contact
[email protected]
410-955-8804
Michael A. Carducci (PRINCIPAL_INVESTIGATOR)
Wake Forest University Health SciencesWinston-SalemNorth Carolina27157
Site Public Contact
336-713-6771
Michael McCormack (PRINCIPAL_INVESTIGATOR)
Ohio State University Comprehensive Cancer CenterColumbusOhio43210
Site Public Contact
[email protected]
800-293-5066
Edmund Folefac (PRINCIPAL_INVESTIGATOR)
UT Southwestern/Simmons Cancer Center-DallasDallasTexas75390-
M D Anderson Cancer CenterHoustonTexas77030
Site Public Contact
[email protected]
877-632-6789
Ana Aparicio (PRINCIPAL_INVESTIGATOR)
University of Wisconsin Carbone Cancer Center - Eastpark Medical CenterMadisonWisconsin53718
Site Public Contact
[email protected]
800-622-8922
John M. Floberg (PRINCIPAL_INVESTIGATOR)
University of Wisconsin Carbone Cancer Center - University HospitalMadisonWisconsin53792
Site Public Contact
[email protected]
800-622-8922
John M. Floberg (PRINCIPAL_INVESTIGATOR)

Find similar trials in Duarte, CA

By research site
City of Hope Comprehensive Cancer Center· Duarte, CALos Angeles General Medical Center· Los Angeles, CAUSC / Norris Comprehensive Cancer Center· Los Angeles, CAUniversity of California Davis Comprehensive Cancer Center· Sacramento, CANorthwestern University· Chicago, ILUniversity of Kentucky/Markey Cancer Center· Lexington, KY

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