Clinical trial NCT01543659: Clinical and Molecular Correlates of Positron Emission Tomography (PET) With 89Zr-DFO-huJ591 in Metastatic Prostate Cancer
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Prostate Cancer
Keywords: 89Zr-DFO-huJ591
prostate
Pet scan
11-126
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Weill Medical College of Cornell University
name: Broad Institute of MIT and Harvard
First posted: 2012-03-05
Enrollment: 77
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: ability of 89Zr-DFO-huJ591 PET to detect known sites of disease
timeFrame: 3 years
measure: the pharmacokinetics (PK) and biodistribution of 89Zr-DFO-huJ591 PET
timeFrame: 3 years
Secondary outcomes:
measure: To use 89Zr-DFO-huJ591 PET image guided biopsies as a means for improved sampling of individual lesions of metastatic prostate cancer
timeFrame: 3 years
measure: PSMA and AR expression and AR axis genomic and proteomic pathways on tumor tissue with the 89Zr-DFO-huJ591 PET imaging characteristics
timeFrame: 3 years
measure: FDG PET with 89Zr-DFO-huJ591 PET tumor uptake
timeFrame: 3 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Michael Morris, MD
role: PRINCIPAL_INVESTIGATOR
References: