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NCT05691465 · ClinicalTrials.gov registry record · Phase 2
Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells
A Phase 2 study of Stage IV Prostate Cancer AJCC v8 and Metastatic Prostate Neuroendocrine Carcinoma, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
- 13
- Study locations
NCT05691465 is a Phase 2 study of Stage IV Prostate Cancer AJCC v8 and Metastatic Prostate Neuroendocrine Carcinoma that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 30 participants, below the 155-participant average among 28 other Stage IV Prostate Cancer AJCC v8 trials with a reported enrollment target (81% lower). The trial reports 13 study locations across 8 states.
The verdict
NCT05691465, a Phase 2 study of Stage IV Prostate Cancer AJCC v8 and Metastatic Prostate Neuroendocrine Carcinoma, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
- 13
- Study locations
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 Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Positron Emission Tomography
- RADIATION Gallium Ga 68-DOTATATE
- DRUG Lutetium Lu 177 Dotatate
Study Locations (13)
California
- City of Hope Comprehensive Cancer Center - Duarte
- Los Angeles General Medical Center - Los Angeles
- USC / Norris Comprehensive Cancer Center - Los Angeles
- University of California Davis Comprehensive Cancer Center - Sacramento
Texas
- UT Southwestern/Simmons Cancer Center-Dallas - Dallas
- M D Anderson Cancer Center - Houston
Wisconsin
- University of Wisconsin Carbone Cancer Center - Eastpark Medical Center - Madison
- University of Wisconsin Carbone Cancer Center - University Hospital - Madison
Illinois
- Northwestern University - Chicago
Kentucky
- University of Kentucky/Markey Cancer Center - Lexington
Maryland
- Johns Hopkins University/Sidney Kimmel Cancer Center - Baltimore
North Carolina
- Wake Forest University Health Sciences - Winston-Salem
Ohio
- Ohio State University Comprehensive Cancer Center - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2023-12-27 |
| Est. Completion | 2026-11-02 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05691465
The ClinicalTrials.gov registry entry for NCT05691465 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 155-participant average among 28 other Stage IV Prostate Cancer AJCC v8 trials with a reported enrollment target (81% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Stage IV Prostate Cancer AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT05691465 reports 13 study locations spanning 8 distinct geographic areas - top geographies include California, Texas, Wisconsin.
Frequently Asked Questions
What is clinical trial NCT05691465 about?
NCT05691465 is a clinical study titled "Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells". 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 endocr...
What is the current status of trial NCT05691465?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2023-12-27. Estimated completion is 2026-11-02.
What conditions does trial NCT05691465 study?
This clinical trial studies the following conditions: Stage IV Prostate Cancer AJCC v8, Metastatic Prostate Neuroendocrine Carcinoma, Metastatic Prostate Adenocarcinoma With Neuroendocrine Differentiation, Metastatic Prostate Small Cell Neuroendocrine Carcinoma.
What interventions are being tested in trial NCT05691465?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Positron Emission Tomography (PROCEDURE), Gallium Ga 68-DOTATATE (RADIATION), Lutetium Lu 177 Dotatate (DRUG).
Who is sponsoring clinical trial NCT05691465?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05691465 being conducted?
This trial has 13 study locations across California, Illinois, Kentucky, Maryland, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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