NCT03448458

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Feb 2018

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 22, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

February 22, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 28, 2018

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 6, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 6, 2023

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

July 17, 2025

Completed
Last Updated

July 17, 2025

Status Verified

July 1, 2025

Enrollment Period

5 years

First QC Date

February 22, 2018

Results QC Date

March 27, 2024

Last Update Submit

July 16, 2025

Conditions

Castration-Resistant Prostate CarcinomaMetastatic Prostate CarcinomaStage IV Prostate Cancer AJCC v7

Outcome Measures

Primary Outcomes (1)

  • Gallium Ga 68-DOTATATE Uptake

    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. low, and apply Wilcoxon rank sum test or Fisher exact test wherever appropriate.

    During PET/CT scan, up to 2 hours

Secondary Outcomes (1)

  • Progression Free Survival

    Date of enrollment to date of progression (radiographic progression or clinical deterioration) or death, or last follow up if event free, assessed up to 36 months

Study Arms (1)

Gallium Ga 68-DOTATATE PET/CT

EXPERIMENTAL

Patients receive gallium Ga 68-DOTATATE IV. Within 55-70 minutes, patients undergo PET (positron emission tomography)/CT (computed tomography).

Procedure: CT (Computed Tomography)Drug: Gallium Ga 68-DOTATATEProcedure: Positron Emission Tomography

Interventions

CT (Computed Tomography)PROCEDURE

Undergo PET/CT

Also known as: CAT, CAT Scan, Computerized Axial Tomography, computerized tomography, CT scan
Gallium Ga 68-DOTATATE PET/CT
Gallium Ga 68-DOTATATEDRUG

Given IV

Also known as: 68Ga-DOTATATE, Gallium-68 DOTA-DPhe1, Tyr3-octreotate
Gallium Ga 68-DOTATATE PET/CT
Positron Emission TomographyPROCEDURE

Undergo PET/CT

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET scan, proton magnetic resonance spectroscopic imaging
Gallium Ga 68-DOTATATE PET/CT

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with metastatic castration resistant prostate carcinoma with skeletal, visceral and/or nodal involvement
  • Ability to lie still for PET scanning
  • Patients must be able to provide written informed consent

You may not qualify if:

  • Patients less than 18 years of age
  • Patients without metastatic castration resistant prostate carcinoma with skeletal, visceral and/or nodal involvement
  • Inability to lie still for PET scanning
  • Patients unable to provide written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Ga(III)-DOTATOCgallium Ga 68 dotatateMagnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Results Point of Contact

Title
Mehmet Asim Bilen, MD
Organization
Emory University
mehmet.a.bilen@emory.edu
404-778-1900

Study Officials

  • Mehmet Asim Bilen, MD

    Emory University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 22, 2018

First Posted

February 28, 2018

Study Start

February 22, 2018

Primary Completion

February 6, 2023

Study Completion

February 6, 2023

Last Updated

July 17, 2025

Results First Posted

July 17, 2025

Record last verified: 2025-07

Locations

US(1)