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

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.

• CT (Computed Tomography) (Procedure), also known as CAT, CAT Scan, Computerized Axial Tomography, computerized tomography, CT scan: Undergo PET/CT
• Gallium Ga 68-DOTATATE (Drug), also known as 68Ga-DOTATATE, Gallium-68 DOTA-DPhe1, Tyr3-octreotate: Given IV
• Positron Emission Tomography (Procedure), also known as Medical Imaging, Positron Emission Tomography, PET, PET scan, proton magnetic resonance spectroscopic imaging: Undergo PET/CT

Primary outcomes

• Gallium Ga 68-DOTATATE Uptake [During PET/CT scan, up to 2 hours]: 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.

Secondary outcomes

• Progression Free Survival [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]: Will be associated with 68Ga-DOTATATE uptake. Will be described by Kaplan-Meier method along log-rank p-value.

Sex: Male, ages: 18 Years to any

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

Participant flow

Outcome results

• Gallium Ga 68-DOTATATE Uptake (Primary), Count of participants, Participants: Gallium Ga 68-DOTATATE PET/CT 11
• Progression Free Survival (Secondary), Mean, months: Gallium Ga 68-DOTATATE PET/CT 8.1 (1.7 to 21.3)

Adverse events

Time frame: 3 years

• Study Protocol and Statistical Analysis Plan (PDF, 2017-11-02)
• Informed Consent Form (PDF, 2019-11-07)

• Mehmet Asim Bilen, MD, Principal investigator, Emory University