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Completed

NCT Number: NCT03448458

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

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.

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Key information

Conditions

Castration-Resistant Prostate Carcinoma Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Metastatic Prostate Carcinoma Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Stage IV Prostate Cancer AJCC v7 Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CT (Computed Tomography)

Procedure

Undergo PET/CT

Other names: CAT, CAT Scan, Computerized Axial Tomography, computerized tomography, CT scan

Gallium Ga 68-DOTATATE

Drug

Given IV

Other names: 68Ga-DOTATATE, Gallium-68 DOTA-DPhe1, Tyr3-octreotate

Positron Emission Tomography

Procedure

Undergo PET/CT

Other names: Medical Imaging, Positron Emission Tomography, PET, PET scan, proton magnetic resonance spectroscopic imaging

Primary outcomes

  1. Gallium Ga 68-DOTATATE Uptake

    Time frame: 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

  1. Progression Free Survival

    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

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

Sponsors and collaborators

Lead sponsor

Emory University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Feb 28, 2018
Registry last updated
Jul 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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