Phase 2 N=17 Diagnostic

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

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

Bottom Line

View on ClinicalTrials.gov: NCT03448458 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2025

Primary outcome: Primary: Gallium Ga 68-DOTATATE Uptake — 11; 4; 1 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: CT (Computed Tomography) (Procedure); Gallium Ga 68-DOTATATE (Drug); Positron Emission Tomography (Procedure)
Age: Adult, Older Adult · 18+ yrs
Sex: Male
Sponsor: Emory University
Primary completion: Feb 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Gallium Ga 68-DOTATATE Uptake	11; 4; 1	—
SECONDARY Progression Free Survival	8.1; 13.3; 36	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03448458). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.