PET/MRI for the Staging of Newly Diagnosed Prostate Cancer

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03392181

Enrollment

Registered

2018-01-05

Start date

2018-06-08

Completion date

2026-06-01

Last updated

2025-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Brief summary

The purpose of this study is to gain understanding of how PET-MR (positron emission tomography-magnetic resonance imaging) using the substance 18F-DCFPyL (PyL) may help in diagnosing prostate cancer and in determining the stage of prostate cancer before surgery.

Interventions

DRUG18F-DCFPyL

To determine whether PET/MR utilizing PYL improves pre-operative staging of prostate cancer prior to radical prostatectomy compared to MRI alone.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 89 Years

Healthy volunteers

Inclusion criteria

* Patients must have a biopsy-proven diagnosis of high risk, very high risk, or locally advanced prostate cancer * Patients must have a diagnosis of high risk, very high risk, or locally advanced prostate cancer per NCCN Guidelines (T3-T4 disease) * Patients are healthy enough to be deemed surgical candidates with an ECOG performance status of 0-2 * Patients must be age ≥ 18 years * Patients must agree to use adequate contraception (e.g. barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 30 days following completion of the imaging * Patients must have the ability to understand and the willingness to sign a written informed consent prior to registration on study

Exclusion criteria

* Patients who have contraindications to MRI (i.e. pacemakers, aneurysm clips or shaped fragments) * Patients who are claustrophobic will be required to take an anti-anxiety medication prescribed by their physician one hour prior to the scan * Patients may not be receiving any other treatments or investigational agents * Patients with a GFR \<30mL/min are ineligible to receive intravenous contrast per standard MR

Design outcomes

Primary

Measure	Time frame	Description
PET/MR versus mp-MRI for the Staging of Newly Diagnosed Prostate Cancer	5 years	To determine if PSMA-Targeted PET/MRI improves pre-operative staging of prostate cancer prior to radical prostatectomy compared to MRI alone.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026