89Zr-DFO-huJ591 PET Scan for Prostate Cancer

Age: 18+

Sex: Male

Trial Phase: Phase 1 & 2

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Anaphylactic reaction, Hepatic issues, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 1-2 weeks

77 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study doctors to get a clear answer.

What data supports the effectiveness of the treatment 89Zr-DFO-huJ591 for prostate cancer?

The studies show that 89Zr-DFO-huJ591 is effective as an imaging tool for detecting prostate cancer metastases, providing better detection compared to standard imaging methods. This suggests it could be useful in identifying the spread of cancer, which is crucial for planning treatment. ^{1 2 3 4 5}

Is 89Zr-DFO-huJ591 safe for use in humans?

In studies involving 89Zr-DFO-huJ591 for prostate cancer imaging, the treatment was generally well-tolerated, with the kidneys being the most exposed organ to radiation. The effective radiation dose was considered manageable, but the potential benefits should be weighed against the radiation exposure. ^{1 2 3 6 7}

How is the 89Zr-DFO-huJ591 PET scan treatment different from other prostate cancer treatments?

The 89Zr-DFO-huJ591 PET scan is unique because it uses a radioactive tracer to specifically target and visualize prostate-specific membrane antigen (PSMA) on cancer cells, allowing for more precise detection of prostate cancer metastases compared to conventional imaging methods. ^{1 2 3 6 8}

What is the purpose of this trial?

This trial is testing a new type of scan to see if it can better detect prostate cancer that has spread, especially to the bones. The scan uses a special substance to highlight cancer cells in the body. Researchers hope this will improve future cancer treatments.

Research Team

Michael Morris, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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.

Inclusion 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.

I am a man and I am 18 years old or older.

Exclusion Criteria

My liver function tests are within normal limits, except I may have Gilbert's disease.

Previous anaphylactic reaction to either J591 or FDG

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Scans

Participants undergo a baseline FDG PET scan up to 14 days before administration of the 89Zr-DFO-huJ591 tracer

2 weeks

1 visit (in-person)

Treatment

Administration of a single dose of the 89Zr-DFO-huJ591 tracer followed by multiple PET scans to assess pharmacokinetics and biodistribution

1-2 weeks

Multiple visits (in-person) on Days 2, 3-6, and 7-8

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 years

Treatment Details

Interventions

• 89Zr-DFO-huJ591

Trial Overview 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.

Participant Groups

Group I: 89Zr-DFO-huJ591 Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Broad Institute of MIT and Harvard

Collaborator

Trials

21

Recruited

16,300+

Weill Medical College of Cornell University

Collaborator

Trials

1,103

Recruited

1,157,000+

Broad Institute

Collaborator

Trials

21

Recruited

16,300+

Findings from Research

In a study involving 50 patients with advanced prostate cancer, (89)Zr-J591 PET/CT imaging was able to detect significantly more osseous metastases (491 sites) compared to conventional imaging methods (339 sites), demonstrating its superior efficacy in identifying bone lesions.

While (89)Zr-J591 showed high accuracy for detecting bone lesions (95.2%), its effectiveness for soft-tissue lesions was lower (60%), indicating that while it is a promising tool for bone metastasis detection, further optimization may be needed for soft-tissue imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Phase I/II Study for Analytic Validation of 89Zr-J591 ImmunoPET as a Molecular Imaging Agent for Metastatic Prostate Cancer. Pandit-Taskar, N., O'Donoghue, JA., Durack, JC., et al.[2022]

In a pilot study involving 11 patients with localized prostate cancer, (89)Zr labeled J591 monoclonal antibody positron emission tomography (PET) successfully identified 72.7% of significant lesions, particularly those with a Gleason score of 7 or higher, indicating its potential efficacy in detecting clinically significant disease.

The study suggests that larger lesions are more easily identified by PET imaging, and there is a correlation between standardized uptake values and Gleason scores, although further research is needed to confirm these findings in a larger clinical trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A prospective pilot study of (89)Zr-J591/prostate specific membrane antigen positron emission tomography in men with localized prostate cancer undergoing radical prostatectomy. Osborne, JR., Green, DA., Spratt, DE., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

A Phase I/II Study for Analytic Validation of 89Zr-J591 ImmunoPET as a Molecular Imaging Agent for Metastatic Prostate Cancer. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

⁸⁹Zr-huJ591 immuno-PET imaging in patients with advanced metastatic prostate cancer. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

A prospective pilot study of (89)Zr-J591/prostate specific membrane antigen positron emission tomography in men with localized prostate cancer undergoing radical prostatectomy. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Clinical trials involving positron emission tomography and prostate cancer: an analysis of the ClinicalTrials.gov database. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

The Impact of 18F-DCFPyL PET-CT Imaging on Initial Staging, Radiation, and Systemic Therapy Treatment Recommendations for Veterans With Aggressive Prostate Cancer. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Targeting the internal epitope of prostate-specific membrane antigen with 89Zr-7E11 immuno-PET. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

An 89Zr-Labeled PSMA Tracer for PET/CT Imaging of Prostate Cancer Patients. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Molecular Imaging of Neuroendocrine Prostate Cancer by Targeting Delta-Like Ligand 3. [2023]