Assessment of Multi-Modality Quantitative Imaging for Evaluation of Response of Metastatic Prostate Cancer to Therapy
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Accuracy for Prediction of Progression Free Survival as determined by Quantitative bone SPECT indices (QBSIs)
研究概览
简要总结
The study is an open label, non-randomized study designed to evaluate the diagnostic performance of SPECT CT.
详细描述
The study is an open label, non-randomized study designed to evaluate the diagnostic performance of SPECT CT. The study will consist of 3 cohorts, and a subset of the patients in cohort C will participate in a test-retest study, where the baseline SPECT/CT will be repeated.
SPECT CT will be performed in all cohorts.
Cohort A will evaluate SPECT CT by comparison to a Positron Emission Tomography (PET) scan using NaF.
Cohort B will evaluate SPECT CT by comparison to 18F-DCFPyL PET/CT.
Cohort C will evaluate SPECT CT by comparison to Whole Body Magnetic Resonance Imaging (WB-MRI).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Males ≥18 years of age. Subjects provide signed informed consent and confirm that they are able and willing to comply with all protocol requirements.
- •Histologically confirmed adenocarcinoma of the prostate. Metastatic castration-resistant prostate cancer (mCRPC) with Bone metastases as manifested by one or more lesions on bone scan.
- •Documented castrate level of serum testosterone (≤50 ng/dl).
- •Documented progressive mCRPC based on at least one of the following criteria:
- •PSA progression defined as 25% increase over baseline value or nadir.
- •Radiographic progression for soft tissue lesions as per Response Evaluation Criteria in Solid Tumors (RECIST 1.1), and/ or radiographic progression for bone lesions as determined by radionuclide bone scan using the consensus guidelines of the PCWG3 criteria.
- •Planning to receive first line novel hormonal therapy with Abiraterone or Enzalutamide for the first time for mCRPC within 4 weeks of documented progression. Baseline scans will be obtained prior to starting new therapy.
排除标准
- •Subjects who are unable to give valid informed consent Subjects who are unwilling or unable to undergo an SPECT, PET or MR exam, including subjects with contra-indications to MR exams.
- •Subjects with prior Enzalutamide and Abiraterone for mCRPC Subjects with prior taxane chemotherapy for mCRPC Subjects administered any radioisotope within five physical half-lives or any IV X-ray contrast medium within 24 hours or any high density oral contrast medium (oral water contrast is acceptable) within 5 days prior to study drug injection.
- •Subjects with any medical condition or other circumstances that, in the opinion of the investigator, compromise obtaining reliable data, achieving study objectives, or completion.
- •Patients with a history reaction to gadolinium contrast agent. For cohort C, patients with renal failure (eGFR < 60ml/min/1.73m2) or patients on dialysis.
研究组 & 干预措施
"Cohort B" - SPECT CT and 18F-DCFPyL PET/CT
Intervention 1: SPECT CT Intervention 2: 18F-DCFPyL PET/CT
干预措施: SPECT CT (Procedure)
"Cohort A" - SPECT CT and NaF PET
Intervention 1: SPECT CT Intervention 2: NaF PET
干预措施: SPECT CT (Procedure)
"Cohort A" - SPECT CT and NaF PET
Intervention 1: SPECT CT Intervention 2: NaF PET
干预措施: 18F-NaF PET/CT (Drug)
"Cohort B" - SPECT CT and 18F-DCFPyL PET/CT
Intervention 1: SPECT CT Intervention 2: 18F-DCFPyL PET/CT
干预措施: 18F-DCFPyL PET/CT (Drug)
"Cohort C" - SPECT CT and WB-MRI
Intervention 1: SPECT CT Intervention 2: WB-MRI
干预措施: SPECT CT (Procedure)
"Cohort C" - SPECT CT and WB-MRI
Intervention 1: SPECT CT Intervention 2: WB-MRI
干预措施: WB-MRI (Procedure)
结局指标
主要结局
Accuracy for Prediction of Progression Free Survival as determined by Quantitative bone SPECT indices (QBSIs)
时间窗: Baseline, 3 months post-treatment, 6 months post-treatment, at time of disease progression assessed up to 5 years
QBSI will be measured on SPECT scans at pre-defined intervals. A lower QBSI would mean likelier progression free survival.
次要结局
- Reproducibility of the QBSIs using test-retest studies in 12 patients(5 years)
- Ability of QBSPECT to detect recurrence of metastatic disease as determined by QBSI in 60 patients.(Baseline, 3 months post-treatment, 6 months post-treatment, at time of disease progression assessed up to 5 years)
- Accuracy of NaF PET/CT as determined by difference in QBSI from SPECT versus QBSI from NaF PET/CT in 20 patients(Baseline, 3 months post-treatment, 6 months post-treatment, at time of disease progression assessed up to 5 years)
- Accuracy of PSMA PET/CT as determined by difference in QBSI from SPECT versus QBSI from PSMA PET/CT in 20 patients(Baseline, 6 months post-treatment, assessed up to 5 years)
- Correlation of QBSI from SPECT/CT to restricted diffusion obtained from whole body MRI(5 years)