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

Metastatic Prostate Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03448458
• Other study ID #: IRB00099167
• Secondary ID: NCI-2017-02055Wi
• Status: Completed
• Phase: Phase 2
• Start date: February 22, 2018
• Est. completion date: February 6, 2023

Study information

• Verified date: March 2023
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: February 6, 2023
• Est. primary completion date: February 6, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• CT (Computed Tomography)
Undergo PET/CT

Drug:
• Gallium Ga 68-DOTATATE
Given IV

Procedure:
• Positron Emission Tomography
Undergo PET/CT

Locations

Country	Name	City	State
United States	Emory University Hospital/Winship Cancer Institute	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gallium Ga 68-DOTATATE uptake	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.	Up to 1 year post-therapy
Secondary	Progression free survival	Will be associated with 68Ga-DOTATATE uptake. Will be described by Kaplan-Meier method along log-rank p-value.	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