NCT01543659CompletedPhase 1/2

Clinical and Molecular Correlates of Positron Emission Tomography (PET) With 89Zr-DFO-huJ591 in Metastatic Prostate Cancer

A Phase I/II Study of Clinical and Molecular Correlates of Positron Emission Tomography (PET) With 89Zr-DFO-huJ591 in Metastatic Prostate Cancer

Source: ClinicalTrials.gov · Last updated 13 Feb 2026

Brief summary (registry, in English)

The purpose of this study is to define the safety and accuracy of 89Zr-DFO-huJ591 PET scans. By improving our ability to find cancer cells, the investigators hope to be able to improve treatment for patients in the future. The study doctors want to determine whether a new kind of scan, called a 89Zr-DFO-huJ591 PET scan, can specifically see prostate cancer that has spread to other parts of the body, especially the bones. The study doctors will also look at how the 89Zr-DFO-huJ591 reacts with the body and how long it stays in the body. The investigators will also ask the patient to have a biopsy performed. The study doctors will compare the findings the investigators see on the scans with findings on the optional tissue biopsy. Finally, the investigators will compare the pictures from a 89Zr-DFO-huJ591 PET scan with those of a standard PET scan (called FDG PET) and standard CT scans or magnetic resonance (MRI) scans or bone scans, depending on which standard scans the doctor has ordered. PET scanning uses a small amount of radiation attached to a molecule that is taken up by the cancer. In this trial, the patient will undergo two types of PET scans. One uses FDG. FDG is a standard tracer for PET scans. The patient will also undergo another type of PET scan that is experimental. This experimental PET uses a radioactive protein called J591. The radiation source is a type of metal called zirconium-89 (89Zr). The whole tracer, J591 plus the 89Zr, is abbreviated as 89Zr-DFO-huJ591. This tracer is what is being studied. The tracer used in a scan should find where the cancer is in the body.

Status (registry): Completed
Phase (registry): Phase 1/2
Study type: Interventional
Enrollment: 77 (actual)
First submitted: 22 Feb 2012
Start date: 21 Feb 2012
Primary completion date: 10 Feb 2026
Lead sponsor: Memorial Sloan Kettering Cancer Center
Diseases: Prostate cancer
NCT number: NCT01543659

What you commit to

Study type: Interventional · Phase 1/2
Participants enrolled: 77
From 21 Feb 2012 to the primary completion date, 10 Feb 2026
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

Previous anaphylactic reaction to either J591 or FDG

Lab values

Hepatic laboratory values
Bilirubin \> 1.5 x ULN (institutional upper limits of normal) Exception: patient's with a history of Gilbert's disease
AST/ALT \> 2.5 x ULN
Albumin \< 2 g/dL

Other

Patients meeting any of the following criteria will not be eligible for study entry (Metastatic and Rising PSA cohorts):

Who the study is looking for

Metastatic Prostate Cancer Patients:
Adult male ≥ 18 years of age
Patients with histologically confirmed prostate cancer at MSKCC
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
- Rising PSA Prostate Cancer Patients:
Adult male ≥18 years of age
Patients with histologically confirmed prostate cancer at MSKCC
Undergone radical prostatectomy
Detectable PSA (\>0.05 ng/mL) that rises on subsequent evaluation
Radiographic evaluation involving bone imaging and cross sectional imaging of at least the pelvis that is negative or equivocal for metastatic disease
Performance status of 60 or higher (Karnofsky scale) (Appendix B)
Ability to understand and willingness to sign a written informed consent document

Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status	New York	United States	Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.