A Phase I/II Study of Clinical and Molecular Correlates of Positron Emission Tomography (PET) With 89Zr-DFO-huJ591 in Metastatic Prostate Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 77
- 试验地点
- 1
- 主要终点
- ability of 89Zr-DFO-huJ591 PET to detect known sites of disease
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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.
- •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
排除标准
- •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
研究组 & 干预措施
89Zr-DFO-huJ591
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.
干预措施: 89Zr-DFO-huJ591 (Drug)
结局指标
主要结局
ability of 89Zr-DFO-huJ591 PET to detect known sites of disease
时间窗: 3 years
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.
the pharmacokinetics (PK) and biodistribution of 89Zr-DFO-huJ591 PET
时间窗: 3 years
For the first 10 patients, 89Zr-DFO-huJ591 PET scan will be repeated on Days 2, 3-6, and 7-8 based on a single injection given at Day 1. The uptake from these subsequent scans will be used to determine the pharmacokinetics and the biodistribution of 89Zr-DFO-huJ591 as a function of time from injection. Pharmacokinetic analysis will be performed using a biexponential model non-compartmental analysis; standard parameters such as AUC, clearance, volume of distribution, Tmax, and Cmax will be reported.
次要结局
- To use 89Zr-DFO-huJ591 PET image guided biopsies as a means for improved sampling of individual lesions of metastatic prostate cancer(3 years)
- FDG PET with 89Zr-DFO-huJ591 PET tumor uptake(3 years)
- PSMA and AR expression and AR axis genomic and proteomic pathways on tumor tissue with the 89Zr-DFO-huJ591 PET imaging characteristics(3 years)