Back to resultsGallium Ga 68-DOTATATE PET/CT in Diagnosing Patients With Metastatic Castration Resistant Prostate Cancer
Primary Purpose
Castration-Resistant Prostate Carcinoma, Metastatic Prostate Carcinoma, Stage IV Prostate Cancer AJCC v7
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CT (Computed Tomography)
Gallium Ga 68-DOTATATE
Positron Emission Tomography
Sponsored by
About this trial
This is an interventional diagnostic trial for Castration-Resistant Prostate Carcinoma
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Emory University Hospital/Winship Cancer Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Gallium Ga 68-DOTATATE PET/CT
Arm Description
Patients receive gallium Ga 68-DOTATATE IV. Within 55-70 minutes, patients undergo PET (positron emission tomography)/CT (computed tomography).
Outcomes
Primary Outcome Measures
Gallium Ga 68-DOTATATE uptake
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.
Secondary Outcome Measures
Progression free survival
Will be associated with 68Ga-DOTATATE uptake. Will be described by Kaplan-Meier method along log-rank p-value.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03448458
Brief Title
Gallium Ga 68-DOTATATE PET/CT in Diagnosing Patients With Metastatic Castration Resistant Prostate Cancer
Official Title
Molecular Imaging With Ga-68 DOTATATE PET to Investigate Neuroendocrine Differentiation in Prostate Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
February 22, 2018 (Actual)
Primary Completion Date
February 6, 2023 (Actual)
Study Completion Date
February 6, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
PRIMARY OBJECTIVE:
Establish the feasibility of using gallium Ga 68-DOTATATE (68Ga-DOTATATE) PET as a predictive imaging biomarker for neuroendocrine transdifferentiation in prostate cancer.
SECONDARY OBJECTIVE:
Correlate progression of disease with degree of uptake on 68Ga-DOTATATE PET examination.
OUTLINE:
Patients receive gallium Ga 68-DOTATATE intravenously (IV). Within 55-70 minutes, patients undergo PET/CT.
After completion of study, patients are followed up for at least 1 year.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Castration-Resistant Prostate Carcinoma, Metastatic Prostate Carcinoma, Stage IV Prostate Cancer AJCC v7
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Gallium Ga 68-DOTATATE PET/CT
Arm Type
Experimental
Arm Description
Patients receive gallium Ga 68-DOTATATE IV. Within 55-70 minutes, patients undergo PET (positron emission tomography)/CT (computed tomography).
Intervention Type
Procedure
Intervention Name(s)
CT (Computed Tomography)
Other Intervention Name(s)
CAT, CAT Scan, Computerized Axial Tomography, computerized tomography, CT scan
Intervention Description
Undergo PET/CT
Intervention Type
Drug
Intervention Name(s)
Gallium Ga 68-DOTATATE
Other Intervention Name(s)
68Ga-DOTATATE, Gallium-68 DOTA-DPhe1, Tyr3-octreotate
Intervention Description
Given IV
Intervention Type
Procedure
Intervention Name(s)
Positron Emission Tomography
Other Intervention Name(s)
Medical Imaging, Positron Emission Tomography, PET, PET scan, proton magnetic resonance spectroscopic imaging
Intervention Description
Undergo PET/CT
Primary Outcome Measure Information:
Title
Gallium Ga 68-DOTATATE uptake
Description
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.
Time Frame
Up to 1 year post-therapy
Secondary Outcome Measure Information:
Title
Progression free survival
Description
Will be associated with 68Ga-DOTATATE uptake. Will be described by Kaplan-Meier method along log-rank p-value.
Time Frame
Date of enrollment to date of progression (radiographic progression or clinical deterioration) or death, or last follow up if event free, assessed up to 1 year
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mehmet Asim Bilen, MD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory University Hospital/Winship Cancer Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Gallium Ga 68-DOTATATE PET/CT in Diagnosing Patients With Metastatic Castration Resistant Prostate Cancer
We'll reach out to this number within 24 hrs