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Prostate CancerPhase 1/2NCT01543659

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

A Phase 1/2 study testing 89Zr-DFO-huJ591 in people with Prostate Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
89Zr-DFO-huJ591
Could I receive a placebo?
No, everyone receives an active treatment
How many people
77 participants
Where
1 siteUnited States
Study dates
21 Feb 2012to 10 Feb 2026
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 21Show fewer
  • 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

Who cannot join

  • Patients meeting any of the following criteria will not be eligible for study entry (Metastatic and Rising PSA cohorts):
  • Previous anaphylactic reaction to either J591 or FDG
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10065

Other trials in United States

About this study

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

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.

Conditions
Prostate Cancer
Being tested
89Zr-DFO-huJ591
Keywords
89Zr-DFO-huJ591, prostate, Pet scan, 11-126
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 89Zr-DFO-huJ591Drug

    Also called Tissue will be analyzed for AR axis genomic and proteomic pathways by Dr. Loda's, laboratory.

    The first 10 patients enrolled in the study will undergo serial whole-body scans to allow assessment of 89Zr-DFO-huJ591 biodistribution. There will be no intervening changes in therapy between the scans. The first 10 patients enrolled will also have serial blood samples drawn for PK analysis (2 -3 mL per time point). The remaining 90 patients enrolled (Patients 11-100) will have only 1 whole-body scan, at a time point to be determined based on the results for the first 10 patients. Biopsies are not mandatory, but highly recommended for the scientific purposes of the study. If feasible and the patient consents, all patients will undergo either or both of the following: (a) core biopsy of soft tissue site of disease; (b) core biopsy of bony site of disease. These biopsies will be performed following the last whole-body scan, prior to initiation of a new intervening therapy, and no more than 4 weeks after 89Zr-DFO-huJ591 administration.

Study groups in NCT01543659
Study groupRoleWhat they receive
89Zr-DFO-huJ591ExperimentalRegistered 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.
Receives: Drug: 89Zr-DFO-huJ591

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ability of 89Zr-DFO-huJ591 PET to detect known sites of disease

    With 50 patients enrolled over 3 years and an anticipated 20 lesions per patient, our estimate of sensitivity will be based on approximately 1000 lesions. Assuming an intra-patient correlation of 0.1 (based on our experience of FDG PET in this disease) we will be able to estimate the sensitivity within ±9% of its true value, assuming that the true sensitivity is 50%. If the sensitivity is higher then our estimates will be more precise. The findings from the optimal scan of 89Zr-DFO-huJ591 PET in the first 10 patients will be used for this purpose.

    Measured: 3 years

  2. the pharmacokinetics (PK) and biodistribution of 89Zr-DFO-huJ591 PET

    For the first 10 patients, 89Zr-DFO-huJ591 PET scan will be repeated on Days 2, 3-6, and 7-8 based on a single injection given at Day 1. The uptake from these subsequent scans will be used to determine the pharmacokinetics and the biodistribution of 89Zr-DFO-huJ591 as a function of time from injection. Pharmacokinetic analysis will be performed using a biexponential model non-compartmental analysis; standard parameters such as AUC, clearance, volume of distribution, Tmax, and Cmax will be reported.

    Measured: 3 years

Secondary outcomes (3)

  1. To use 89Zr-DFO-huJ591 PET image guided biopsies as a means for improved sampling of individual lesions of metastatic prostate cancer

    The hit rate, defined as presence of tumor in the biopsied lesion, will be compared with the historical control of 25% (which is the estimated hit rate of FDG PET from our previous studies). Based on historical experience in this patient population we anticipate that we will obtain 33 biopsied lesions (an average contribution of 1 biopsied lesion from 33 consenting patients), which will provide approximately 80% power to distinguish hit rates of 25% and 45% (one-sample two-sided binomial test controlling Type I error at 5%).

    Measured: 3 years

  2. PSMA and AR expression and AR axis genomic and proteomic pathways on tumor tissue with the 89Zr-DFO-huJ591 PET imaging characteristics

    89Zr-DFO-huJ591 uptake will be compared by PSMA and AR expression on tumor tissues (present/absent) using the rank-sum test. Results will also be presented using side-by-side histograms and box plots.

    Measured: 3 years

  3. FDG PET with 89Zr-DFO-huJ591 PET tumor uptake

    All lesions with uptake will be used to correlate the accumulation of 89Zr-DFO-huJ591 to FDG. The width of the estimated confidence interval as a function of the value of the correlation coefficient (ρ) are given in Table 3. This assumes that uptake is normally distributed and for planning purposes only. Actual data analysis will make use of the rank correlation. These values conservatively assume a single lesion per patient. With multiple lesions per patient, narrower confidence intervals will be obtained.

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2012 (estimated)
  2. Study start21 Feb 2012
  3. Primary completion10 Feb 2026
  4. Study completion10 Feb 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
77 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01543659
Sponsor's protocol ID
11-126
Status last verified
Feb 2026
First submitted
22 Feb 2012
Last updated
13 Feb 2026
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing 89Zr-DFO-huJ591 in people with Prostate Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ability of 89Zr-DFO-huJ591 PET to detect known sites of disease (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01543659.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.

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