NCT04050215

68GA-PSMA-11 PET/CT Scan in Impacting Treatment Strategies for Patients With Prostate Cancer

Impact of 68GA-PSMA-11 PET/CT on Initial and Subsequent Treatment Strategies of Patients With Prostate Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 937 (actual)
• Sponsor: Jonsson Comprehensive Cancer Center · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies the impact of 68GA-PSMA-11 positron emission tomography (PET)/computed tomography (CT) scan on treatment strategies for patients with prostate cancer. Diagnostic imaging procedures, such as 68GA-PSMA-11 PET/CT scan, may help doctors plan the best treatment for prostate cancer.

Detailed description

PRIMARY OBJECTIVES: I. To determine the impact of gallium Ga 68-labeled PSMA-11 (68Ga-PSMA-11) PET/CT on initial and subsequent treatment strategies of patients with prostate cancer. OUTLINE: Patients receive 68Ga-PSMA-11 intravenously (IV) and undergo PET/CT scan over 3 hours. Patients may be reenrolled in the study, if 68Ga-PSMA-11 PET/CT is performed for subsequent management decision. After completion of study, patients are followed up within 3-12 months.

Conditions

• Biochemically Recurrent Prostate Carcinoma
• Metastatic Prostate Carcinoma
• Prostate Adenocarcinoma
• Prostate Carcinoma
• PSA Level Greater Than Fifty
• PSA Progression
• Stage IV Prostate Cancer AJCC v8
• Stage IVA Prostate Cancer AJCC v8
• Stage IVB Prostate Cancer AJCC v8

Interventions

Type	Name	Description
PROCEDURE	Computed Tomography	Undergo PET/CT
DRUG	Gallium Ga 68-labeled PSMA-11	Given IV
PROCEDURE	Positron Emission Tomography	Undergo PET/CT
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2018-04-02
• Primary completion: 2021-09-27
• Completion: 2021-09-27
• First posted: 2019-08-08
• Last updated: 2021-09-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study