Study on New PET Scan Technique for Detecting Metastatic Prostate Cancer

Sponsor: Memorial Sloan Kettering Cancer Center

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT01543659

Provider View

This clinical trial is testing a new PET scan method using a special tracer, 89Zr-DFO-huJ591, to see if it can better detect prostate cancer that has spread, especially to the bones. The study aims to improve future treatments by comparing this new scan with standard imaging methods.

Patient Parameters

Program Overview

The study is exploring a new PET scan technique using a tracer called 89Zr-DFO-huJ591 to see if it can accurately find prostate cancer that has spread to other parts of the body, particularly the bones. Researchers will compare this new scan with standard PET scans and other imaging tests like CT or MRI scans. The study will also look at how the tracer interacts with the body and how long it stays in the system. Participants may be asked to have a biopsy to compare scan results with tissue samples.

Eligibility Criteria

Inclusion Criteria

  • Men aged 18 or older with metastatic prostate cancer.
  • Confirmed prostate cancer diagnosis at MSKCC.
  • Cancer that is getting worse, shown by:
    • New bone lesions on a bone scan, or
    • Increased or new soft tissue disease on MRI or CT scans.
  • Rising PSA levels, with at least 3 increases from a baseline, or 2 increases over 2 weeks apart, with a 25% increase.
  • Visible lesions on CT, bone scan, or MRI.
  • Performance status of 60 or higher on the Karnofsky scale.
  • Ability to understand and sign a consent form.

For patients with rising PSA:

  • Men aged 18 or older with confirmed prostate cancer at MSKCC.
  • Had a radical prostatectomy.
  • Detectable PSA (>0.05 ng/mL) that continues to rise.
  • Imaging of bones and pelvis that does not clearly show metastatic disease.
  • Performance status of 60 or higher on the Karnofsky scale.
  • Ability to understand and sign a consent form.

Exclusion Criteria

  • Previous severe allergic reaction to J591 or FDG.
  • Liver function tests showing:
    • Bilirubin levels more than 1.5 times the normal limit (except for Gilbert's disease).
    • AST/ALT levels more than 2.5 times the normal limit.
    • Albumin levels less than 2 g/dL.

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