← Back to Search

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months following standard hifu therapy

Awards & highlights

Study 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

Select...

My prostate cancer has a high Gleason score or extensive spread in biopsies.

Select...

My cancer is in an early stage and has not spread deeply.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months following standard hifu therapy

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Alessandro D'AgnoloLead Sponsor

Progenics Pharmaceuticals, Inc.Industry Sponsor

33 Previous Clinical Trials

4,889 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How is 18F-PSMA typically implemented to address medical concerns?

"The radiotracer 18F-PSMA is frequently used to reduce abnormally elevated Prostate Specific Antigen (PSA) levels. It can also be deployed in positron emission tomography and as a treatment option for recurrent prostate cancer, or suspected metastasis."

Answered by AI

What is the foremost intent of this experiment?

"This trial, which will be assessed over a six-month period following standard HIFU therapy, aims to evaluate the primary endpoint of HIFU. Secondary outcomes include assessing rate of high grade cancer via tumor mapping and repeat prostate biopsy; determining negative biopsy rate post-HIFU treatment; and measuring specificity of hrMRI, F18-PSMA PET, and mpMRI scans for detecting all tumors and metastasis at 6 months follow up."

Answered by AI

Has 18F-PSMA been granted authorization by the FDA?

"Our team at Power believes that 18F-PSMA has a safety rating of 2, as we have evidence for its security but not yet proof of efficacy."

Answered by AI

Are there any vacancies available for participants in this medical trial?

"Affirmative. The information on clinicaltrials.gov affirms that recruitment for this medical trial is live, having been posted initially on April 6th 2021 and most recently edited June 2nd 2022. This trial requires 80 participants to be gathered from a single site."

Answered by AI

What findings have been produced from earlier explorations with 18F-PSMA?

"Presently, 18F-PSMA is the subject of eighteen ongoing studies. Of those trials, none are in Phase 3; however, some 27 different locations across Baltimore and Maryland are researching this medication."

Answered by AI

How many participants are engaging in this experiment?

"Affirmative. Details hosted on clinicaltrials.gov demonstrate that this trial is still recruiting participants, with the initial posting being published on April 6th 2021. The latest update was issued June 2nd 2022 and 80 patients are required at a single medical centre for enrollment in this research project."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

High Resolution, 18F-PSMA PET-MRI Before Prostate Cancer HIFU or Radical Prostatectomy

Alessandro D'Agnolo 2021. "High Resolution, 18F-PSMA PET-MRI Before Prostate Cancer HIFU or Radical Prostatectomy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04461509.

All > Prostate Cancer Anaheim > Prostate