18F-PSMA-1007 PET/CT Imaging in Patients With Biochemically Recurrent or High-risk Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Safety - post scan
研究概览
简要总结
Single centre prospective cohort phase II study of 18F-PSMA-1007 PET/CT imaging in patients with biochemically recurrent or high-risk prostate cancer. Safety, biodistribution, clinical efficacy, and diagnostic accuracy will be assessed. For diagnostic accuracy comparison will be made to a contemporary (within 10 days) conventional imaging study (bone scan and CT scan).
详细描述
A single centre prospective cohort phase II study of 18F-PSMA-1007 PET/CT imaging in specific patient populations:
- Adult patients (≥ 18 years old) with a history of radical prostatectomy for treatment of prostate cancer, and a serum prostate specific antigen (PSA) > 0.2 µg/L
- Adult patients (≥ 18 years old) with a history of radiotherapy, cryotherapy, or brachytherapy for treatment of prostate cancer, and a serum PSA progressively rising to ≥ 2 µg/L (minimum two samples) OR a serum PSA doubling-time of < 9 months
- Adult patients (≥ 18 years old) with a history of biopsy-proven prostate cancer and high-risk features for metastatic disease prior to treatment with radical prostatectomy, radiotherapy, cryotherapy, or brachytherapy. High-risk features include a Gleason score > 7, serum PSA > 20 µg/L, OR minimum clinical T-stage T2c.
All patients will have a comparison conventional imaging study performed within 10 days of the investigational PET/CT scan. The conventional imaging study will include a 99mTc -MDP bone scan including whole body planar imaging (top of skull to toes) as well as SPECT/CT imaging of the trunk (including clavicles to pelvis). In the absence of contraindications (renal failure with eGFR < 40 mL/min/1.73m2 or history of IV contrast allergy), all scans will include an IV-contrast enhanced CT scan of the chest, abdomen, and pelvis. In the presence of contraindications to IV contrast, a non-IV contrast enhanced CT scan of the chest, abdomen, and pelvis will be performed.
The biodistribution of 18F-PSMA-1007 produced by the Edmonton PET Centre will be evaluated in 2 ways:
- by comparing the biodistribution of tracer on the scans to an expected normal distribution.
- for any identified abnormal distribution, a lesion-by-lesion comparison to the conventional imaging study will be performed with lesions classified as follows:
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
- •Adult patients (≥ 18 years old) with a history of radical prostatectomy for treatment of prostate cancer, and a serum prostate specific antigen (PSA) > 0.2 µg/L
- •Adult patients (≥ 18 years old) with a history of radiotherapy, cryotherapy, or brachytherapy for treatment of prostate cancer, and a serum PSA progressively rising to ≥ 2 µg/L (minimum two samples) OR a serum PSA doubling-time of < 9 months
- •Adult patients (≥ 18 years old) with a history of biopsy-proven prostate cancer and high-risk features for metastatic disease prior to treatment with radical prostatectomy, radiotherapy, cryotherapy, or brachytherapy. High-risk features include a Gleason score > 7, serum PSA > 20 µg/L, OR minimum clinical T-stage T2c.
排除标准
- •Unable to obtain consent
- •Weight >225 kg (weight limitation of PET/CT scanner)
- •Unable to lie flat for 30 minutes to complete the PET-CT imaging session
- •Lack of intravenous access
- •Both CT scan of the chest, abdomen, and pelvis and 99mTc-MDP bone scan within 3 months
- •History of allergic reaction to 18F-PSMA-1007 or 99mTc-MDP
结局指标
主要结局
Safety - post scan
时间窗: 2.5 hours after 18F-PSMA-1007 injection
Incidence of tracer-emergent adverse events including allergic reaction (hives, difficulty breathing) or pain at the injection site
Safety - delayed
时间窗: 6 months after 18F-PSMA-1007 injection
Questionnaire (open-ended) to referring physicians to document any perceived delayed adverse events related to 18F-PSMA-1007 tracer injection
Biodistribution
时间窗: Within 5 days of scan
Evaluation of whether tracer distribution is as expected based on published normal distribution and known disease
Safety - immediate
时间窗: Immediately (within 15 minutes) after 18F-PSMA-1007 injection
Incidence of tracer-emergent adverse events including allergic reaction (hives, difficulty breathing) or pain at the injection site
Diagnostic Accuracy
时间窗: 1 year after 18F-PSMA-1007 PET/CT scan
Lesion by lesion comparison to conventional imaging (bone scan and CT scan) performed 2-10 days after the 18F-PSMA-1007 PET/CT scan. Reference standard based on lesion pathology (if available) or 1 year clinical/imaging following (using criteria published by Lawhn-Heath et al., AJR 2019;213:1-8.
次要结局
- Clinical Efficacy(6 months after the 18F-PSMA-1007 PET/CT scan)