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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
Progressive disease manifest by either: Imaging modalities: Bone Scan: New osseous lesions on bone scan and/or MRI or CT: An increase in measurable soft tissue disease or the appearance of new sites of disease. OR Biochemical progression: At least 3 rising PSA values from a baseline that are obtained 1 week or more apart, or 2 measurements obtained 2 or more weeks apart. The increase over the range of values should be at least 25%. Visible lesions by CT, bone scan, or MRI that are consistent with disease Performance status of 60 or higher (Karnofsky scale) (Appendix B) Ability to understand and willingness to sign a written informed consent document
Adult male ≥18 years of age
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a man and I am 18 years old or older.
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I am mostly able to care for myself and carry out daily activities.
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I am a man and I am 18 years old or older.
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My prostate cancer diagnosis was confirmed through a biopsy at MSKCC.
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My prostate cancer diagnosis was confirmed through tissue analysis at MSKCC.
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I have had surgery to remove my prostate.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

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.

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,927 Previous Clinical Trials
591,330 Total Patients Enrolled
131 Trials studying Prostate Cancer
65,827 Patients Enrolled for Prostate Cancer
Weill Medical College of Cornell UniversityOTHER
1,051 Previous Clinical Trials
1,329,668 Total Patients Enrolled
48 Trials studying Prostate Cancer
49,481 Patients Enrolled for Prostate Cancer
Broad InstituteOTHER
19 Previous Clinical Trials
16,200 Total Patients Enrolled
1 Trials studying Prostate Cancer
5,290 Patients Enrolled for Prostate Cancer

Media Library

89Zr-DFO-huJ591 Clinical Trial Eligibility Overview. Trial Name: NCT01543659 — Phase 1 & 2
Prostate Cancer Research Study Groups: 89Zr-DFO-huJ591
Prostate Cancer Clinical Trial 2023: 89Zr-DFO-huJ591 Highlights & Side Effects. Trial Name: NCT01543659 — Phase 1 & 2
89Zr-DFO-huJ591 2023 Treatment Timeline for Medical Study. Trial Name: NCT01543659 — Phase 1 & 2

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."

Answered by AI
~5 spots leftby Feb 2025