Overview

This trial is active, not recruiting.

Condition prostate cancer
Treatment 89zr-dfo-huj591
Phase phase 1/phase 2
Sponsor Memorial Sloan Kettering Cancer Center
Collaborator Weill Medical College of Cornell University
Start date February 2012
End date February 2017
Trial size 77 participants
Trial identifier NCT01543659, 11-126

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose diagnostic
Arm
(Experimental)
Registered 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.
89zr-dfo-huj591 Tissue will be analyzed for AR axis genomic and proteomic pathways by Dr. Loda's
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.

Primary Outcomes

Measure
ability of 89Zr-DFO-huJ591 PET to detect known sites of disease
time frame: 3 years
the pharmacokinetics (PK) and biodistribution of 89Zr-DFO-huJ591 PET
time frame: 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
time frame: 3 years
PSMA and AR expression and AR axis genomic and proteomic pathways on tumor tissue with the 89Zr-DFO-huJ591 PET imaging characteristics
time frame: 3 years
FDG PET with 89Zr-DFO-huJ591 PET tumor uptake
time frame: 3 years

Eligibility Criteria

Male participants at least 18 years old.

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

Additional Information

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
Principal investigator Michael Morris, MD
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center.