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89Zr-DFO-huJ591 PET Scan for Prostate Cancer
Phase 1 & 2
Waitlist Available
Led By Michael Morris, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
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 3 years
Awards & highlights
Study Summary
This trial is studying a new type of PET scan to see if it can more accurately find prostate cancer that has spread to other parts of the body.
Who is the study for?
This trial is for adult males over 18 with confirmed prostate cancer at MSKCC, showing disease progression either through scans or rising PSA levels. Participants must have a performance status of 60+ on the Karnofsky scale and be able to consent. Men who've had anaphylactic reactions to J591 or FDG, or those with certain abnormal liver test results are excluded.Check my eligibility
What is being tested?
The study tests the safety and accuracy of a new PET scan using an experimental tracer called 89Zr-DFO-huJ591, aimed at detecting metastatic prostate cancer. It compares this new scan's effectiveness against standard imaging techniques like CT, MRI, bone scans, and FDG PET scans.See study design
What are the potential side effects?
Potential side effects may include reactions related to the small amount of radiation from the tracer used in PET scanning. Specific side effects aren't detailed but could also involve typical risks associated with biopsy procedures if one is performed.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Disease
the pharmacokinetics (PK) and biodistribution of 89Zr-DFO-huJ591 PET
Secondary outcome measures
Positron-Emission Tomography
PSMA and AR expression and AR axis genomic and proteomic pathways on tumor tissue with the 89Zr-DFO-huJ591 PET imaging characteristics
To use 89Zr-DFO-huJ591 PET image guided biopsies as a means for improved sampling of individual lesions of metastatic prostate cancer
Trial Design
1Treatment groups
Experimental Treatment
Group I: 89Zr-DFO-huJ591Experimental Treatment1 Intervention
Registered patients will undergo a baseline FDG PET scan up to 14 days before administration of a single dose of the 89Zr-DFO-huJ591 tracer, this scan is considered for research purposes. The exception to the 14-day timeframe is that patients who have already had an FDG PET scan up to 4 weeks prior to registration are not required to repeat the FDG PET scan on study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
89Zr-DFO-huJ591
2012
Completed Phase 2
~80
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,938 Previous Clinical Trials
588,298 Total Patients Enrolled
132 Trials studying Prostate Cancer
51,435 Patients Enrolled for Prostate Cancer
Weill Medical College of Cornell UniversityOTHER
1,059 Previous Clinical Trials
1,316,000 Total Patients Enrolled
48 Trials studying Prostate Cancer
34,534 Patients Enrolled for Prostate Cancer
Broad InstituteOTHER
19 Previous Clinical Trials
16,233 Total Patients Enrolled
1 Trials studying Prostate Cancer
5,290 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a man and I am 18 years old or older.I am mostly able to care for myself and carry out daily activities.My liver function tests are within normal limits, except I may have Gilbert's disease.I am a man and I am 18 years old or older.My prostate cancer diagnosis was confirmed through tissue analysis at MSKCC.I have had surgery to remove my prostate.
Research Study Groups:
This trial has the following groups:- Group 1: 89Zr-DFO-huJ591
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.
Are there still positions available for participation in this experiment?
"Reported on clinicaltrials.gov, this study is no longer seeking patients as the most recent amendment was made on February 28th 2022. Nonetheless, there are still 1321 other trials actively searching for participants right now."
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