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

Emory University

Status and phase: Completed; Phase 2

Conditions: Stage IV Prostate Cancer AJCC v7; Castration-Resistant Prostate Carcinoma; Metastatic Prostate Carcinoma

Treatments: Drug: Gallium Ga 68-DOTATATE; Procedure: Positron Emission Tomography; Procedure: CT (Computed Tomography)

Study type: Interventional

Funder types: Other

Identifiers

NCT03448458

Winship4165-17 (Other Identifier)

IRB00099167

NCI-2017-02055 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 17 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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17 participants in 1 patient group

Gallium Ga 68-DOTATATE PET/CT

Experimental group

Description:

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

Treatment:

Procedure: CT (Computed Tomography)

Procedure: Positron Emission Tomography

Drug: Gallium Ga 68-DOTATATE