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PET-MRI Imaging for Prostate Cancer

Phase < 1
Recruiting
Led By Ashley E Ross
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 90 days
Awards & highlights

Summary

This trial uses PET-MRI and MRI scans to detect higher grade prostate cancer in men with low risk. It uses a radioactive drug to create detailed images of how organs and tissues are working.

Who is the study for?
Men aged 18+ with a life expectancy of at least 10 years, diagnosed with low or favorable intermediate risk prostate cancer (Gleason Grade Group 1 or 2), who have not had prior treatments for prostate cancer. They must have had a recent biopsy informed by mpMRI and be willing to undergo another biopsy. Those with certain concurrent diseases are allowed.
What is being tested?
The trial is testing if PET-MRI scans using rhPSMA-7.3 can better detect advanced stages of prostate cancer in men suitable for active surveillance. It compares detailed images from the radioactive drug rhPSMA-7.3 combined with MRI technology against standard diagnostic methods.
What are the potential side effects?
Potential side effects may include reactions to the radioactive drug like nausea, discomfort at injection site, allergic reactions, and temporary changes in blood tests. MRI-related side effects could involve discomfort due to loud noises or claustrophobia during the scan.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 90 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 90 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Radio-pathological correlation between positron emession tomography-magnetic resonance imaging (PET-MRI) and prostate biopsy or radical prostatectomy
Secondary study objectives
Incidence of Treatment-Related Adverse Events [Safety and Tolerability]

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (rhPSMA, PET-MRI, mpMRI)Experimental Treatment7 Interventions
Patients receive rhPSMA-7.3 IV then undergo PET-MRI and mpMRI of the prostate on study. Patients also undergo Decipher test at screening and MRI-PET prostate biopsy or radical prostatectomy within 90 days per standard of care.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160
Multiparametric Magnetic Resonance Imaging
2021
Completed Early Phase 1
~10
Positron Emission Tomography
2011
Completed Phase 2
~2200
Radical Prostatectomy
2005
Completed Phase 2
~4550

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor
1,625 Previous Clinical Trials
937,249 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,002,960 Total Patients Enrolled
Ashley E RossPrincipal InvestigatorNorthwestern University

Media Library

Treatment (rhPSMA, PET-MRI, mpMRI) Clinical Trial Eligibility Overview. Trial Name: NCT05852041 — Phase < 1
Prostate Adenocarcinoma Research Study Groups: Treatment (rhPSMA, PET-MRI, mpMRI)
Prostate Adenocarcinoma Clinical Trial 2023: Treatment (rhPSMA, PET-MRI, mpMRI) Highlights & Side Effects. Trial Name: NCT05852041 — Phase < 1
Treatment (rhPSMA, PET-MRI, mpMRI) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05852041 — Phase < 1
~27 spots leftby Jun 2027
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