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

Emory University17 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

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

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Gallium Ga 68-DOTATATE Uptake

The number of participants with uptake in each type of lesion will be reported. 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.

Time frame: During PET/CT scan, up to 2 hours

Secondary Outcomes

Progression Free Survival

Will be associated with 68Ga-DOTATATE uptake. Will be described by Kaplan-Meier method along log-rank p-value.

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 36 months