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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new type of PET scan to better detect prostate cancer that has spread, particularly to bones. The scan uses a special tracer, 89Zr-DFO-huJ591, to observe its reaction in the body and compare its images to standard scans. Men with worsening prostate cancer or rising PSA levels after surgery might qualify for this trial. The goal is to enhance future cancer treatments by improving the detection of cancer cells in the body. As a Phase 1, Phase 2 trial, this research aims to understand how the new imaging agent works in people and measure its effectiveness in an initial group, offering participants a chance to contribute to advancements in cancer detection.

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 prior data suggests that the 89Zr-DFO-huJ591 PET scan is safe for prostate cancer patients?

Research has shown that the 89Zr-DFO-huJ591 PET scan is generally safe for people. In studies with prostate cancer patients, this new scan was well-tolerated, and most did not experience major side effects. The scan uses a small amount of radiation, which remains in the body for only a short time. It effectively detected cancer in the liver. Overall, current research suggests that the scan is safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the 89Zr-DFO-huJ591 PET scan for prostate cancer because it offers a new way to visualize cancer cells in the body. Unlike standard imaging techniques, this method uses a targeted tracer, 89Zr-DFO-huJ591, that specifically binds to prostate cancer cells, potentially providing clearer and more precise images. This could help doctors detect cancer earlier and track how well a treatment is working, which is a significant improvement over traditional imaging that might not be as specific. The use of this novel tracer could lead to better treatment decisions and outcomes for patients with prostate cancer.

What evidence suggests that the 89Zr-DFO-huJ591 PET scan is effective for detecting prostate cancer?

Research has shown that the 89Zr-DFO-huJ591 PET scan, which participants in this trial will undergo, is promising for detecting prostate cancer that has spread, particularly to the bones. In one study with 50 patients who had advanced prostate cancer, this scan identified 491 cancer spots in the bones. The scan effectively detects prostate-specific membrane antigen (PSMA), which is linked to prostate cancer cells. Another study demonstrated it was 95.2% accurate in identifying bone lesions, areas where cancer has spread to the bone. These findings suggest that the 89Zr-DFO-huJ591 PET scan could be a valuable tool for detecting and understanding the spread of prostate cancer. ^{1 2 4 5 6}

Who Is on the Research Team?

Michael Morris, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4404641/

89Zr-huJ591 immuno-PET imaging in patients with advanced ... Conclusion. Zr-huJ591 PET imaging of prostate-specific membrane antigen expression is safe and shows good localization of disease in prostate cancer patients. ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4668231/

A Phase I/II Study for Analytic Validation of 89Zr-J591 ... Based on the imaging analysis, biopsy results, and statistical projections, we conclude that 89Zr-J591targeted imaging of PSMA is highly sensitive and accurate ...

3. withpower.com withpower.com/trial/phase-2-prostatic-neoplasms-1-2012-c2a3a

89Zr-DFO-huJ591 PET Scan for Prostate Cancer 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) ...

4. pubs.acs.org pubs.acs.org/doi/10.1021/mp500164r

Noninvasive Imaging of PSMA in Prostate Tumors with 89 Zr ... These results demonstrated significantly improved PK attributes of both 89Zr-labeled antibody fragments with retained tumor targeting properties and shorter ...

5. aacrjournals.org aacrjournals.org/clincancerres/article/doi/10.1158/1078-0432.CCR-15-0552/176637/am/A-Phase-I-II-Study-for-Analytic-Validation-of-89Zr

A Phase I/II Study for Analytic Validation of 89Zr-J591 ... The overall accuracy of 89Zr-J591 was 95.2% (20/21) for osseous lesions and 60% (15/25) for soft tissue lesions. Conclusions: 89Zr-J591 imaging demonstrated ...

6. jnm.snmjournals.org jnm.snmjournals.org/content/60/11/1517

Imaging Patients with Metastatic Castration-Resistant Prostate ... Compared with prior studies on prostate cancer with 89Zr-DFO-huJ591, our study showed a much higher sensitivity for detecting soft-tissue ...