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NCT03448458 · ClinicalTrials.gov registry record · Phase 2

Gallium Ga 68-DOTATATE PET/CT in Diagnosing Patients With Metastatic Castration Resistant Prostate Cancer

A Phase 2 study of Castration-Resistant Prostate Carcinoma and Metastatic Prostate Carcinoma, sponsored by Emory University.

Completed
Registry status
Phase 2
Development phase
17
Enrollment target
1
Study location

NCT03448458: Completed Phase 2 study of Castration-Resistant Prostate Carcinoma and Metastatic Prostate Carcinoma, sponsored by Emory University.

NCT03448458 is a Phase 2 study of Castration-Resistant Prostate Carcinoma and Metastatic Prostate Carcinoma that has completed, run by Emory University. The registered enrollment target is 17 participants, below the 78-participant average among 43 other Castration-Resistant Prostate Carcinoma trials with a reported enrollment target (78% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03448458, a Phase 2 study of Castration-Resistant Prostate Carcinoma and Metastatic Prostate Carcinoma, has completed, sponsored by Emory University.

COMPLETED
Registry status
Phase 2
Development phase
17 participants
Enrollment target
1
Study location

Study Summary

This pilot clinical trial studies how well gallium Ga 68-DOTATATE positron emission tomography (PET)/computed tomography (CT) works in treating patients with castration resistant prostate cancer that has spread to other placed in the body. Gallium Ga 68-DOTATATE PET/CT may help doctors to identify those patients with early neuroendocrine transdifferentiation and who are at greater risk for poor outcomes.

Primary Outcome

The number of participants with uptake in each type of lesion will be reported. Will be summarized using descriptive statistics. The inter-rater agreement will be assessed by Kappa statistics or intra-class correlation coefficient. The degree of uptake will be plotted against length of time to progress, and the association will be described by Spearman correlation coefficient with 95% confidence interval (CI). In addition, will dichotomize degree of update by median and defined it as high vs. lo

Interventions

  • PROCEDURE Positron Emission Tomography
  • DRUG Gallium Ga 68-DOTATATE
  • PROCEDURE CT (Computed Tomography)

Study Locations (1)

Georgia

  • Emory University Hospital/Winship Cancer Institute - Atlanta

Trial Details

FieldValue
Enrollment Target 17 participants
Start Date 2018-02-22
Est. Completion 2023-02-06
Phase Phase 2
Emory University

1,208 total trials

What the finished NCT03448458 record still lists

NCT03448458 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 78-participant average among 43 other Castration-Resistant Prostate Carcinoma trials with a reported enrollment target (78% lower).

The record links to 3 conditions, with Castration-Resistant Prostate Carcinoma appearing as the primary indexed condition, and to 3 interventions - of which Positron Emission Tomography is the first listed.

NCT03448458 reports a single indexed study location in Georgia.

Frequently Asked Questions

What is clinical trial NCT03448458 about?

NCT03448458 is a clinical study titled "Gallium Ga 68-DOTATATE PET/CT in Diagnosing Patients With Metastatic Castration Resistant Prostate Cancer". This pilot clinical trial studies how well gallium Ga 68-DOTATATE positron emission tomography (PET)/computed tomography (CT) works in treating patients with castration resistant prostate cancer that has spread to other placed in the body. Gallium Ga 68-DOTATATE PET/CT may help doctors to identify t...

What is the current status of trial NCT03448458?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 17 participants. The study started on 2018-02-22. Estimated completion is 2023-02-06.

What conditions does trial NCT03448458 study?

This clinical trial studies the following conditions: Castration-Resistant Prostate Carcinoma, Metastatic Prostate Carcinoma, Stage IV Prostate Cancer AJCC v7.

What interventions are being tested in trial NCT03448458?

The interventions under investigation include: Positron Emission Tomography (PROCEDURE), Gallium Ga 68-DOTATATE (DRUG), CT (Computed Tomography) (PROCEDURE).

Who is sponsoring clinical trial NCT03448458?

This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03448458 being conducted?

This trial has 1 study location across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Castration-Resistant Prostate Carcinoma

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 NCT03448458's enrollment target sits among peer trials

17 34th of 43 higher than 10 of 43 other Castration-Resistant Prostate Carcinoma trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Castration-Resistant Prostate Carcinoma 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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Source: ClinicalTrials.gov NCT03448458, the US trial registry maintained by the National Library of Medicine. NCT03448458 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.