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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: Recruiting Phase 2 study of Stage IV Prostate Cancer AJCC v8 and Metastatic Prostate Neuroendocrine Carcinoma, sponsored by National Cancer Institute (NCI).

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

The objective response rate according to Prostate Cancer Working Group (PCWG) 3 criteria will be assessed by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). ORR will be reported along with the corresponding two-sided 95% confidence interval. The confidence interval will be adjusted for the two-stage design structure. This analysis will be based on the intent-to-treat population.

Conditions Studied

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

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

FieldValue
Enrollment Target 30 participants
Start Date 2023-12-27
Est. Completion 2026-11-02
Phase Phase 2
National Cancer Institute (NCI)

3,257 total trials

What NCT05691465 shows while recruiting

NCT05691465 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 155-participant average among 28 other Stage IV Prostate Cancer AJCC v8 trials with a reported enrollment target (81% lower).

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 lists 13 locations in 8 states (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.

Learn More About Clinical Trials

Similar trials for Stage IV Prostate Cancer AJCC v8

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05691465's enrollment target sits among peer trials

30 23rd of 28 higher than 3 of 28 other Stage IV Prostate Cancer AJCC v8 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Stage IV Prostate Cancer AJCC v8 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT05691465

Source: ClinicalTrials.gov NCT05691465, the US trial registry maintained by the National Library of Medicine. NCT05691465 (small enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.