NCT03448458

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

Molecular Imaging With Ga-68 DOTATATE PET to Investigate Neuroendocrine Differentiation in Prostate Cancer Patients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Emory University · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Castration-Resistant Prostate Carcinoma
• Metastatic Prostate Carcinoma
• Stage IV Prostate Cancer AJCC v7

Interventions

Type	Name	Description
PROCEDURE	CT (Computed Tomography)	Undergo PET/CT
DRUG	Gallium Ga 68-DOTATATE	Given IV
PROCEDURE	Positron Emission Tomography	Undergo PET/CT

Timeline

• Start date: 2018-02-22
• Primary completion: 2023-02-06
• Completion: 2023-02-06
• First posted: 2018-02-28
• Last updated: 2025-07-17
• Results posted: 2025-07-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study