NCT03404648

Staging Prostate Cancer With Hybrid C11-Choline PET/MR and mpMRI

Staging of Untreated Patients With Very High-risk and High-risk Prostate Carcinoma Utilizing Hybrid C11-choline PET/MR and Pelvic Multiparametric MRI for Personalized Precise Treatment: a Pilot Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to find out if a PET/MR scan in combination with standard MRI and CT scans can improve the early detection and treatment of patients with prostate cancer.

Detailed description

High risk prostate cancer patients will undergo C11-Choline PET/MR whole body fusion scan and pelvic mpMRI for accurate staging. The PET/MR imaging findings, including the primary lesion with the prostate bed and pelvic lymph nodes, will be correlated with the histopathologic result. Researchers aim to provide accurate one-stop shopping opportunity in diagnosis and staging of high risk prostate cancer using the C11-choline PET/MR scan.

Conditions

• Prostate Adenocarcinoma

Interventions

Type	Name	Description
DRUG	C-11 choline PET tracer	C-11 choline PET tracer, One dose, totally 12-14 millicurie (mCi), intravenous administration while patient is lying on the table.
DRUG	Gadobutrol	Single dose of Gadavist® (Gadobutrol, Bayer) at no more than 0.1 mmol/kg will be administrated intravenously.
DEVICE	PET/MR scanner	C11-PET/MR and pelvic mpMRI scan for prostate cancer.

Timeline

• Start date: 2017-11-01
• Primary completion: 2020-01-23
• Completion: 2020-01-23
• First posted: 2018-01-19
• Last updated: 2021-02-08
• Results posted: 2021-02-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study