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PET/MRI for the Staging of Newly Diagnosed Prostate Cancer | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGEARLY_PHASE1

PET/MRI for the Staging of Newly Diagnosed Prostate Cancer

NCT03392181•Northwestern University

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.

Eligibility

Age

18 - 89 years

Sex

MALE

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 not interested in pursuing surgical intervention for their disease (i.e. refusing treatment or requesting radiation oncology referral)
•Patients who have received androgen deprivation therapy or prior surgery for prostate cancer
•Patients who report taking multivitamins and/or folate supplements on the day of the scan

Locations (1)

Northwestern University

Chicago, Illinois, United States

Key Dates

Start Date

June 8, 2018

Primary Completion Date

May 1, 2026

Completion Date

June 1, 2026

Last Updated

May 23, 2025

Enrollment

ESTIMATED participants

Conditions

Prostate Cancer

Interventions

18F-DCFPyL

DRUG

Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells

NCT05691465

Metastatic Prostate Adenocarcinoma With Neuroendocrine DifferentiationMetastatic Prostate Neuroendocrine Carcinoma+2 more

View study

RECRUITINGPHASE2

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

NCT06842498

Metastatic Castration-Resistant Prostate Cancer

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 23, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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PET/MRI for the Staging of Newly Diagnosed Prostate Cancer

Inclusion Criteria

Exclusion Criteria

Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

PSMA-PET: Deep Radiomic Biomarkers of Progression and Response Prediction in Prostate Cancer

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

Phase 2a Study of High-Dose Testosterone Followed by Radioligand Therapy in mCRPC