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

Sponsor
Emory University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03448458
Collaborator
(none)
17
Enrollment
1
Location
1
Arm
66.1
Anticipated Duration (Months)
0.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: CT (Computed Tomography)
  • Drug: Gallium Ga 68-DOTATATE
  • Procedure: Positron Emission Tomography
 Phase 2

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
17 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Molecular Imaging With Ga-68 DOTATATE PET to Investigate Neuroendocrine Differentiation in Prostate Cancer Patients
Actual Study Start Date :
Feb 22, 2018
Anticipated Primary Completion Date :
Aug 26, 2023
Anticipated Study Completion Date :
Aug 26, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Gallium Ga 68-DOTATATE PET/CT

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

Procedure: CT (Computed Tomography)
Undergo PET/CT
Other Names:
  • CAT
  • CAT Scan
  • Computerized Axial Tomography
  • computerized tomography
  • CT scan

    • Drug: Gallium Ga 68-DOTATATE
    Given IV
    Other Names:
  • 68Ga-DOTATATE
  • Gallium-68 DOTA-DPhe1, Tyr3-octreotate

    • Procedure: Positron Emission Tomography
    Undergo PET/CT
    Other Names:
  • Medical Imaging, Positron Emission Tomography
  • PET
  • PET scan
  • proton magnetic resonance spectroscopic imaging

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Gallium Ga 68-DOTATATE uptake [Up to 1 year post-therapy]

      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

    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 1 year]

      Will be associated with 68Ga-DOTATATE uptake. Will be described by Kaplan-Meier method along log-rank p-value.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Emory University Hospital/Winship Cancer Institute Atlanta Georgia United States 30322

    Sponsors and Collaborators

    • Emory University

    Investigators

    • Principal Investigator: Mehmet Asim Bilen, MD, Emory University

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Mehmet Bilen, Principal Investigator, Emory University
    ClinicalTrials.gov Identifier:
    NCT03448458
    Other Study ID Numbers:
    • IRB00099167
    • NCI-2017-02055
    • Winship4165-17
    First Posted:
    Feb 28, 2018
    Last Update Posted:
    Mar 4, 2022
    Last Verified:
    Mar 1, 2022
    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
    Additional relevant MeSH terms:
    Carcinoma
    Prostatic Neoplasms

    Study Results

    No Results Posted as of Mar 4, 2022