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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03448458
Recruitment Status : Recruiting
First Posted : February 28, 2018
Last Update Posted : February 28, 2018
Information provided by (Responsible Party):
Mehmet Bilen, Emory University

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
Castration-Resistant Prostate Carcinoma Metastatic Prostate Carcinoma Stage IV Prostate Cancer AJCC v7 Procedure: CT (Computed Tomography) Drug: Gallium Ga 68-DOTATATE Procedure: Positron Emission Tomography Phase 2

Detailed Description:


Establish the feasibility of using gallium Ga 68-DOTATATE (68Ga-DOTATATE) PET as a predictive imaging biomarker for neuroendocrine transdifferentiation in prostate cancer.


Correlate progression of disease with degree of uptake on 68Ga-DOTATATE PET examination.


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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
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 : February 22, 2018
Estimated Primary Completion Date : February 28, 2022
Estimated Study Completion Date : February 28, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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:
  • 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

Primary Outcome Measures :
  1. Gallium Ga 68-DOTATATE uptake [ Time Frame: 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 [ 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 ]
    Will be associated with 68Ga-DOTATATE uptake. Will be described by Kaplan-Meier method along log-rank p-value.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03448458

Contact: Mehmet Asim Bilen, MD 404-778-3448
Contact: Ephraim Parent, MD, PhD 404-712-4843

United States, Georgia
Emory University Hospital/Winship Cancer Institute Recruiting
Atlanta, Georgia, United States, 30322
Contact: Wilena Session    404-778-3448   
Sponsors and Collaborators
Emory University
Principal Investigator: Mehmet Asim Bilen, MD Emory University

Responsible Party: Mehmet Bilen, Principal Investigator, Emory University Identifier: NCT03448458     History of Changes
Other Study ID Numbers: IRB00099167
NCI-2017-02055 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
Winship4165-17 ( Other Identifier: Winship Cancer Institute )
First Posted: February 28, 2018    Key Record Dates
Last Update Posted: February 28, 2018
Last Verified: February 2018

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:
Prostatic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases