A Phase 2 interventional study of CT (Computed Tomography) and Gallium Ga 68-DOTATATE in Castration-Resistant Prostate Carcinoma, Metastatic Prostate Carcinoma and Stage IV Prostate Cancer AJCC v7, sponsored by Emory University. Completed at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-17.
Sponsored by Emory University · Phase 2, Interventional, and Diagnostic
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.
Exclusion Criteria:
Patients receive gallium Ga 68-DOTATATE IV. Within 55-70 minutes, patients undergo PET (positron emission tomography)/CT (computed tomography).
Procedure: CT (Computed Tomography) · Drug: Gallium Ga 68-DOTATATE · Procedure: Positron Emission Tomography
Undergo PET/CT
Also known as: CAT, CAT Scan, Computerized Axial Tomography, computerized tomography, CT scan
Given IV
Also known as: 68Ga-DOTATATE, Gallium-68 DOTA-DPhe1, Tyr3-octreotate
Undergo PET/CT
Also known as: Medical Imaging, Positron Emission Tomography, PET, PET scan, proton magnetic resonance spectroscopic imaging
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
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
| Milestone | Gallium Ga 68-DOTATATE PET/CT |
|---|---|
| Started | 17 |
| Completed | 16 |
| Not completed | 1 |
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.
| Participants | Gallium Ga 68-DOTATATE PET/CT |
|---|---|
| Bone and visceral/nodal lesions | 11 |
| Only bone lesions | 4 |
| Only nodal disease | 1 |
Will be associated with 68Ga-DOTATATE uptake. Will be described by Kaplan-Meier method along log-rank p-value.
| months | Gallium Ga 68-DOTATATE PET/CT |
|---|---|
| Marked Ga-DOTATATE uptake found in 7 of 16 patients analyzed and with a Gleason score range of 7-9 | 8.1 (1.7 to 21.3) |
| Moderate Ga-DOTATATE uptake with a Gleason score of 9 | 13.3 (2.9 to 20.6) |
| Mild Ga-DOTATATE uptake with a Gleason score range of 7-8 | 36 (36 to 36) |
Collected over 3 years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Gallium Ga 68-DOTATATE PET/CT | 2/17 (11.8%) | 0/17 (0%) | 0/17 (0%) |
| Age, Categorical(Participants) | Gallium Ga 68-DOTATATE PET/CT |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 9 |
| >=65 years | 8 |
| Sex: Female, Male(Participants) | Gallium Ga 68-DOTATATE PET/CT |
|---|---|
| Female | 0 |
| Male | 17 |
| Ethnicity (NIH/OMB)(Participants) | Gallium Ga 68-DOTATATE PET/CT |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 15 |
| Unknown or Not Reported | 2 |
| Race (NIH/OMB)(Participants) | Gallium Ga 68-DOTATATE PET/CT |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 8 |
| White | 6 |
| More than one race | 0 |
| Unknown or Not Reported | 2 |
| Region of Enrollment(participants) | Gallium Ga 68-DOTATATE PET/CT |
|---|---|
| United States | 17 |
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Emory University