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Gadopiclenol for Prostate Cancer

Phase 4
Waitlist Available
Led By B. Nicolas Bloch, MD
Research Sponsored by University of Massachusetts, Worcester
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Have already begun therapeutic treatment for prostate cancer including surgery (TURP, prostatectomy), radiotherapy, hormone therapy or chemotherapy.
Patients with end stage renal failure who are on dialysis.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion (an average of 1 year post-mri)
Awards & highlights
No Placebo-Only Group
Drug Has Already Been Approved
Pivotal Trial

Summary

This trial aims to demonstrate that a new contrast agent called Gadopiclenol (Elucirem) can enhance the visibility of prostate cancer on MRI scans, making it easier to identify and distinguish clinically

Who is the study for?
This trial is for individuals with prostate cancer who are candidates for MRI. Specific eligibility criteria aren't provided, but typically participants must be in good health aside from their prostate cancer and able to undergo an MRI.
What is being tested?
The study is testing Gadopiclenol (Elucirem), a new contrast agent used during an MRI of the prostate. The goal is to see if it provides clearer images that help distinguish aggressive prostate cancer using PI-RADS v2 categories.
What are the potential side effects?
While specific side effects of Gadopiclenol are not listed here, common side effects of contrast agents include mild pain, cold feeling at the injection site, headache, or nausea.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have started treatment for prostate cancer, including surgery, radiotherapy, hormone therapy, or chemotherapy.
Select...
I am on dialysis for end-stage kidney failure.
Select...
I do not have chronic or acute kidney disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion (an average of 1 year post-mri)
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion (an average of 1 year post-mri) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Blinded Radiology Review of Enhancement of Images, Graded 1-5
Secondary study objectives
Quantitative Measurements of Wash-In/Wash-Out Contrast Curve

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: GadopiclenolExperimental Treatment1 Intervention
Gadopiclenol in dose, route of administration, and indication that is FDA-approved.

Find a Location

Who is running the clinical trial?

GuerbetIndustry Sponsor
70 Previous Clinical Trials
94,431 Total Patients Enrolled
University of Massachusetts, WorcesterLead Sponsor
362 Previous Clinical Trials
992,900 Total Patients Enrolled
1 Trials studying Prostate Cancer
5 Patients Enrolled for Prostate Cancer
B. Nicolas Bloch, MDPrincipal InvestigatorUMass Chan Medical School
~100 spots leftby Feb 2027
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