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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
Study 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.Check my eligibility
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.See study design
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 90 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 90 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Radio-pathological correlation between positron emession tomography-magnetic resonance imaging (PET-MRI) and prostate biopsy or radical prostatectomy
Secondary outcome measures
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
~1190
Positron Emission Tomography
2008
Completed Phase 2
~2240
Radical Prostatectomy
2005
Completed Phase 2
~4550
Find a Location
Who is running the clinical trial?
Northwestern UniversityLead Sponsor
1,589 Previous Clinical Trials
917,086 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,669 Previous Clinical Trials
40,926,361 Total Patients Enrolled
Ashley E RossPrincipal InvestigatorNorthwestern University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't taken any experimental drugs within the last 28 days or 5 half-lives.I have had treatments like radiotherapy or surgery for prostate cancer.I have had a hip replacement surgery.I have had a procedure done to improve urine flow from my bladder.My Decipher test score is below 0.45.I haven't taken hormone therapies for cancer in the last month.I am a healthy man over 18 with a life expectancy of 10+ years.My prostate cancer is low grade (Gleason score 6 or 7).I can understand and am willing to sign the study's consent form.I agree to have a prostate biopsy before starting non-surgical treatment and within 90 days after a PET-MRI scan.My biopsy score is 0.45 or higher.My prostate cancer is considered low or favorable risk.I have other health conditions or cancers alongside my current diagnosis.My last prostate biopsy was 3-15 months ago, guided by an MRI, with at least 10 samples taken.My prostate cancer is in the very low risk category.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (rhPSMA, PET-MRI, mpMRI)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research project currently recruiting participants?
"According to clinicaltrials.gov, this research is no longer recruiting participants - the initial post was published on June 7th 2023 and it last updated May 9th 2023. Fortunately, there are 1290 other trials that require patients at present."
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