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New scan could spot hidden prostate cancer spread

NCT ID NCT01543659

Diagnosis Sponsor: Memorial Sloan Kettering Cancer Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new type of PET scan using a radioactive tracer called 89Zr-DFO-huJ591 to find prostate cancer that has spread to other parts of the body. 77 men with metastatic prostate cancer received the experimental scan, and some also had standard scans and biopsies for comparison. The goal was to see if the new scan is safe and accurate at detecting cancer sites, especially in bones.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
89Zr-DFO-huJ591 (a radioactive tracer for PET scans)
What this could lead to
If successful, this could lead to a more accurate way to detect metastatic prostate cancer, helping doctors choose better treatments.
What could go wrong
This is an early-phase study with only 77 participants. The new scan may not be more accurate than existing methods, and results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

77 people

The number who actually took part.

Started

Feb 2012

Finished

Feb 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 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 Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

metastatic prostate carcinoma prostate cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Prostate cancer

Contacts and locations

Locations

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10065, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.