NCT02678351

68Ga-PSMA-11 PET/MRI in Finding Tumors in Patients With Intermediate or High-Risk Prostate Cancer Undergoing Surgery

68Ga-PSMA-11 PET/MRI for Detection of Regional Nodal and Distant Metastases in Patients With Intermediate and High-Risk Prostate Cancer

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Andrei Iagaru · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase 2-3 trial studies the utility of 68-gallium (68Ga)-prostate-specific membrane antigen 11 (PSMA-11) positron emission tomography/magnetic resonance imaging (PET/MRI) to find tumors in patients with prostate cancer who are undergoing resection surgery for prostate cancer that is prognostically expected to spread quickly (intermediate-risk) or is likely to come back or spread (high-risk). Diagnostic procedures, such as PET/MRI, may help find and diagnose prostate cancer, and reveal out how far the disease has spread. Radioactive drugs, such as 68Ga-PSMA-11, may bind to tumor cells that have specific receptors, and may allow doctors to see smaller tumors than the standard of care contrast-enhanced computed tomography (CT) or MRI scan.

Detailed description

OBJECTIVES: 1. To evaluate 68Ga-PSMA-11 PET/MRI for detection of tumor metastases in patients with intermediate and high-risk prostate cancer scheduled to undergo prostatectomy with lymph node dissection. 2. To assess sensitivity (positive predictive value) and specificity (negative predictive value) of 68Ga-PSMA-11 PET/MRI for the detection of regional nodal metastases compared to pathology at radical prostatectomy. OUTLINE: Participants will receive 68Ga-PSMA-11 intravenously (IV). Patients then undergo PET/MRI after 45 minutes of administration of radiopharmaceutical injection. After completion of study, patients are followed up at 24 to 48 hours.

Conditions

• Stage II Prostate Adenocarcinoma
• Stage III Prostate Adenocarcinoma

Interventions

Type	Name	Description
DRUG	68Ga-PSMA-11	Undergo 68Ga-PSMA-11 PET/MRI
PROCEDURE	Magnetic resonance imaging (MRI)	Undergo 68Ga-PSMA-11 PET/MRI
PROCEDURE	Positron Emission Tomography (PET)	Undergo 68Ga-PSMA-11 PET/MRI

Timeline

• Start date: 2016-04-18
• Primary completion: 2020-12-13
• Completion: 2021-12-01
• First posted: 2016-02-09
• Last updated: 2022-03-04
• Results posted: 2022-03-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study