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

Phase 2

Completed

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

• Registration Number: NCT03448458
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2018-02-22
• Study First Submitted: 2018-02-22
• Study First Submitted QC: 2018-02-27
• Study First Posted: 2018-02-28
• Primary Completion: 2023-02-06
• Study Completion: 2023-02-06
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-03
• Last Update Posted: 2023-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 17

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Gallium Ga 68-DOTATATE PET/CT	CT (Computed Tomography)	Patients receive gallium Ga 68-DOTATATE IV. Within 55-70 minutes, patients undergo PET (positron emission tomography)/CT (computed tomography).
Gallium Ga 68-DOTATATE PET/CT	Gallium Ga 68-DOTATATE	Patients receive gallium Ga 68-DOTATATE IV. Within 55-70 minutes, patients undergo PET (positron emission tomography)/CT (computed tomography).
Gallium Ga 68-DOTATATE PET/CT	Positron Emission Tomography	Patients receive gallium Ga 68-DOTATATE IV. Within 55-70 minutes, patients undergo PET (positron emission tomography)/CT (computed tomography).

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Emory University Hospital/Winship Cancer Institute; 🇺🇸 Atlanta, Georgia, United States