NCT04777071

An Investigational Scan (68Ga-PSMA-11 PET) for the Imaging of Prostate Cancer

68Ga-PSMA-11 PET in Patients With Prostate Cancer

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 141 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This trial studies how well 68Ga-PSMA-11 PET scan works in imaging patients with prostate cancer. Diagnostic procedures, such as 68Ga-PSMA-11 PET may find and diagnose prostate cancer and improve monitoring of treatment response.

Detailed description

OUTLINE: Patients receive gallium Ga 68-labeled PSMA-11 intravenously (IV) over 60-75 minutes then undergo PET/CT or PET/magnetic resonance (MR) scan over 2-4 minutes per bed position at baseline. Patients receiving systemic therapy undergo an additional 68Ga-PSMA-11 PET/CT or PET/MR scan 12 weeks after initiating therapy. Patients may also undergo CT and bone scan during screening and on study. After the completion of study, patients are followed up at 60 days, 6 months, and annually up to 5 years or until time of first progression.

Conditions

• Biochemically Recurrent Prostate Carcinoma
• Metastatic Castration-Resistant Prostate Carcinoma
• Prostate Adenocarcinoma
• Stage IIC Prostate Cancer AJCC v8
• Stage III Prostate Cancer AJCC v8
• Stage IVB Prostate Cancer AJCC v8

Interventions

Type	Name	Description
PROCEDURE	Computed Tomography	Undergo PET/CT scan
DRUG	Gallium Ga 68 Gozetotide	Given IV
PROCEDURE	Positron Emission Tomography	Undergo PET/CT scan
PROCEDURE	Magnetic Resonance Imaging	Undergo PET/MR scan
PROCEDURE	Bone Scan	Undergo bone scan
OTHER	Electronic Health Record Review	Ancillary studies

Timeline

• Start date: 2021-05-17
• Primary completion: 2025-07-15
• Completion: 2030-07-15
• First posted: 2021-03-02
• Last updated: 2026-01-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study