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18F-PSMA PET-MRI Imaging for Prostate Cancer

Phase 2
Waitlist Available
Led By Alessandro D'Agnolo, MD
Research Sponsored by Alessandro D'Agnolo
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Either overall Gleason score > 7 with Gleason grade 4 or 5 component localized to one lobe (i.e. right or left) OR overall Gleason score 6 with > half of systematic biopsy cores positive and > 50% of core involvement in at least one core (for HIFU arm only)
cT1-cT2c
Must not have
Previous local therapy for prostate cancer
Estimated glomerular filtration rate (GFR) <15 mL/min/1.73 m2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months following standard hifu therapy
Awards & highlights

Summary

This trial will use two new imaging technologies to see if they can detect prostate cancers that standard MRI couldn't.

Who is the study for?
This trial is for men with prostate cancer who have a specific Gleason score indicating tumor severity and localization, or extensive biopsy involvement. They must be considering focal HIFU therapy or robotic surgery, have not had previous local treatments for prostate cancer, can undergo PET-MRI scans, and have sufficient kidney function.Check my eligibility
What is being tested?
The study is testing the effectiveness of high resolution DWI and 18F-PSMA PET-MRI imaging technologies in detecting prostate cancers that may not be visible on standard MRI scans in patients eligible for focal HIFU treatment or radical prostatectomy.See study design
What are the potential side effects?
Potential side effects include reactions to the PET tracer used during imaging (such as mild allergic reactions), discomfort from lying still during the MRI procedure, and possible anxiety related to claustrophobia inside the MRI machine.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My prostate cancer has a high Gleason score or extensive spread in biopsies.
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My cancer is in an early stage and has not spread deeply.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had treatment directly on my prostate before.
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My kidney function is severely reduced.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months following standard hifu therapy
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months following standard hifu therapy for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Primary Endpoint (HIFU)
Primary Endpoint (Prostatectomy)
Secondary outcome measures
Secondary Endpoint (HIFU)
Secondary Endpoint (Prostatectomy)
Other outcome measures
Exploratory Endpoint

Trial Design

2Treatment groups
Experimental Treatment
Group I: ARM 2 (RP) - 18F-PSMAExperimental Treatment1 Intervention
10 mCi ±20% F18-PSMA injection
Group II: ARM 1 (HIFU) - 18F-PSMAExperimental Treatment1 Intervention
10 mCi ±20% F18-PSMA injection
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
18F-PSMA
2018
Completed Phase 1
~10

Find a Location

Who is running the clinical trial?

Alessandro D'AgnoloLead Sponsor
Progenics Pharmaceuticals, Inc.Industry Sponsor
33 Previous Clinical Trials
4,297 Total Patients Enrolled
Alessandro D'Agnolo, MDPrincipal Investigator - Cedars-Sinai Medical Center
Cedars-Sinai Medical Center

Media Library

Prostate Disease Research Study Groups: ARM 2 (RP) - 18F-PSMA, ARM 1 (HIFU) - 18F-PSMA
~14 spots leftby Jul 2025
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