A Phase II Study of Lutetium Lu 177 Dotatate in Metastatic Prostate Cancer With Neuroendocrine Differentiation
National Cancer Institute (NCI)
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.
Description
PRIMARY OBJECTIVE: I. Evaluate the objective response rate at 6 months for patients treated with lutetium Lu 177 dotatate using Prostate Cancer Working Group (PCWG) 3 criteria. SECONDARY OBJECTIVES: I. Evaluate the 6-month radiographic progression-free survival of neuroendocrine-differentiated prostate cancer treated with lutetium Lu 177 dotatate. II. Determine if the change in fludeoxyglucose (FDG)-positron emission tomography (PET) signal from pre-treatment to after 2 doses of lutetium Lu 177 dotatate correlates with objective response rate. EXPLORATORY OBJECTIVES: I. Evaluate the pote…
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria: * PRE-REGISTRATION ELIGIBILITY * Patients must have metastatic prostate cancer with neuroendocrine differentiation, as determined by at least one of the following: * Histologically confirmed small cell or neuroendocrine cancer from a primary prostate or metastatic biopsy. Neuroendocrine prostate cancer includes mixed small cell with adenocarcinoma histology, as well as small or large cells with positive neuroendocrine markers (e.g., chromogranin or synaptophysin) * Prostate adenocarcinoma with molecular features of neuroendocrine differentiated cancer (e.g., 2 of the…
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 CenterDuarte, California
- Los Angeles General Medical CenterLos Angeles, California
- USC / Norris Comprehensive Cancer CenterLos Angeles, California
- University of California Davis Comprehensive Cancer CenterSacramento, California
- Northwestern UniversityChicago, Illinois
- University of Kentucky/Markey Cancer CenterLexington, Kentucky