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


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

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


Inclusion Criteria:



- 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

Exclusion Criteria:

- Patients meeting any of the following criteria will not be eligible for study entry:

- Previous anaphylactic reaction to either J591 or FDG

- Hepatic laboratory values

- Bilirubin > 1.5 x ULN (institutional upper limits of normal)

- AST/ALT > 2.5 x ULN

- Albumin < 2 g/dL

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

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

Outcome Description:

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.

Outcome Time Frame:

3 years

Safety Issue:

No

Principal Investigator

Michael Morris, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

11-126

NCT ID:

NCT01543659

Start Date:

February 2012

Completion Date:

February 2015

Related Keywords:

  • Prostate Cancer
  • 89Zr-DFO-huJ591
  • prostate
  • Pet scan
  • 11-126
  • Prostatic Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021