A PrOspective Phase 2/3 Multi-Center Study of 18F-DCFPyL PET/CT Imaging in Patients With PRostate Cancer: Examination of Diagnostic AccuracY (OSPREY)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 385
- 试验地点
- 10
- 主要终点
- Sensitivity of 18F-DCFPyL PET/CT Imaging to Detect Metastatic Prostate Cancer Within the Pelvic Lymph Nodes Relative to Histopathology in High Risk Prostate Cancer Participants (Cohort A)
研究概览
简要总结
This study evaluates the safety and diagnostic performance of 18F-DCFPyL Injection in patients with at least high risk prostate cancer who are planned for radical prostatectomy with lymphadenectomy (Cohort A) or in patients with locally recurrent or metastatic disease willing to undergo biopsy (Cohort B).
Cohort B is complete and no longer recruiting subjects.
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
- •Histologically confirmed adenocarcinoma of the prostate.
- •Subjects provide signed informed consent and confirm that they are able and willing to comply with all protocol requirements.
- •Cohort A Only:
- •At least high risk prostate cancer defined by NCCN Guidelines Version 3.2016 (clinical stage ≥T3a or PSA >20 ng/mL or Gleason score ≥8).
- •Scheduled or planned radical prostatectomy with PLND.
- •Cohort B Only: [Enrollment is complete; No longer recruiting subjects]
- •Radiologic evidence of local recurrence or new or progressive metastatic disease demonstrated on anatomical imaging (CT, MRI, or ultrasound), whole-body bone scan (99m-Tc-MDP or Na-18F) within 4 weeks of enrollment.
- •If prior treatment with radiation or ablative therapy, evidence of recurrence outside the confines of prior treated site(s) is needed.
- •Scheduled or planned percutaneous biopsy of at least one amenable lesion.
排除标准
- •Subjects administered any high energy (>300 KeV) gamma-emitting radioisotope within five physical half-lives, or any IV iodinated 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 circumstance that, in the opinion of the investigator, compromise obtaining reliable data, achieving study objectives, or completion.
- •Cohort A Only:
- •Patients with prior androgen deprivation therapy or any investigational neoadjuvant agent or intervention
- •Cohort B Only: [Enrollment is Complete; No longer recruiting subjects]
- •Prior radiation or ablative therapy to intended site of biopsy, if within the prostate bed
- •Initiation of new therapy for recurrent and/or progressive metastatic disease since radiographic documentation of recurrence/progression.
研究组 & 干预措施
18F-DCFPyL Injection
9±1 mCi (333±37 MBq) IV injection of 18F-DCFPyL
干预措施: 18F-DCFPyL Injection (Drug)
18F-DCFPyL Injection
9±1 mCi (333±37 MBq) IV injection of 18F-DCFPyL
干预措施: PET/CT imaging (Diagnostic Test)
结局指标
主要结局
Sensitivity of 18F-DCFPyL PET/CT Imaging to Detect Metastatic Prostate Cancer Within the Pelvic Lymph Nodes Relative to Histopathology in High Risk Prostate Cancer Participants (Cohort A)
时间窗: Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur.
The primary analysis in Cohort A will test the co-primary endpoints of sensitivity and specificity of 18F-DCFPyL PET/CT imaging relative to histopathology for metastatic disease in pre-prostatectomy patients. For each co-primary endpoint there will be three independent imaging readers. At least two of the three readers must reject the null hypothesis for specificity to be deemed a success. If specificity is a success, then the same two readers need to reject the null hypothesis for sensitivity to reach overall success of the primary endpoint.
Specificity of 18F-DCFPyL PET/CT Imaging to Detect Metastatic Prostate Cancer Within the Pelvic Lymph Nodes Relative to Histopathology in High Risk Prostate Cancer Participants (Cohort A)
时间窗: Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur.
The primary analysis in Cohort A will test the co-primary endpoints of sensitivity and specificity of 18F-DCFPyL PET/CT imaging relative to histopathology for metastatic disease in pre-prostatectomy patients. For each co-primary endpoint there will be three independent imaging readers. At least two of the three readers must reject the null hypothesis for specificity to be deemed a success. If specificity is a success, then the same two readers need to reject the null hypothesis for sensitivity to reach overall success of the primary endpoint.
次要结局
- Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure)(From time of screening (baseline) until pre-surgery/biopsy (within 28 days post-study drug dosing).)
- Shift From Baseline in Selected Clinical Chemistry Laboratory Values at Follow-up (Safety Outcome Measure)(From time of screening (baseline) until pre-surgery/biopsy (within 28 days post-study drug dosing).)
- Changes From Baseline in Electrocardiogram (ECG) Parameters (Safety Outcome Measure)(Changes in ECG pre-drug dosing and within 1-2 hours post-dosing)
- Mean Change From Baseline in Respiration Rate Post 18F-DCFPyL Dosing (Safety Outcome Measure)(Measured at two intervals on the day of dosing, pre-dosing (baseline) and post-dosing/pre-imaging.)
- Mean Change From Baseline in Temperature Post 18F-DCFPyL Dosing (Safety Outcome Measure)(Measured at two intervals on the day of dosing, pre-dosing (baseline) and post-dosing/pre-imaging.)
- Mean Changes From Baseline in Blood Pressure Post 18F-DCFPyL Dosing (Safety Outcome Measure)(Measured at two intervals on the day of dosing, pre-dosing (baseline) and post-dosing/pre-imaging.)
- Mean Change From Baseline in Heart Rate Post 18F-DCFPyL Dosing (Safety Outcome Measure)(Measured at two intervals on the day of dosing, pre-dosing (baseline) and post-dosing/pre-imaging.)
- Sensitivity of 18F-DCFPyL PET/CT Imaging to Detect Prostate Cancer Within Sites of Metastasis or Local Recurrence Relative to Histopathology in Participants With Recurrent or Metastatic Prostate Cancer (Cohort B)(Within 28 days of 18F-DCFPyL PET/CT imaging, conventional image-guided biopsy occurred.)
- Positive Predictive Value (PPV) of 18F-DCFPyL PET/CT to Predict Prostate Cancer Within the Prostate Gland of High Risk Prostate Cancer Participants (Cohort A)(Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur.)
- Negative Predictive Value (NPV) of 18F-DCFPyL PET/CT to Predict Prostate Cancer Within the Prostate Gland of High Risk Prostate Cancer Participants (Cohort A)(Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur.)
- Positive Predictive Value (PPV) of 18F-DCFPyL PET/CT to Predict Prostate Cancer Within the Lymph Nodes of High Risk Prostate Cancer Participants (Cohort A)(Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur.)
- Negative Predictive Value (NPV) of 18F-DCFPyL PET/CT to Predict Prostate Cancer Within the Lymph Nodes of High Risk Prostate Cancer Participants (Cohort A)(Within 28 days of imaging, radical prostatectomy with pelvic lymph node dissection will occur.)
- Positive Predictive Value (PPV) of 18F-DCFPyL PET/CT Imaging to Predict Prostate Cancer Within Sites of Local Recurrence and Other Metastatic Lesions in Participants With Recurrent or Metastatic Prostate Cancer (Cohort B)(Within 28 days of 18F-DCFPyL PET/CT imaging, conventional image-guided biopsy will occur.)
- Comparison of Detection Rates for Lesion Counts By Location and Overall Between 18F-DCFPyL PET/CT and Conventional Imaging(Within 1-2 hours of 18F-DCFPyL dosing, a whole body PET/CT scan will be taken)
- Peak Plasma Concentration (Cmax) of 18F-DCFPyL in a Subset of Participants(Samples were collected at 0, 5, 15, 30, 60, 120, 240, 360, and 480 minutes after administration of 18F-DCFPyL.)
- Area Under the Plasma Concentration Versus Time Curve (AUC) of 18F-DCFPyL in a Subset of Participants(Samples were collected at 0, 5, 15, 30, 60, 120, 240, 360, and 480 minutes after administration of 18F-DCFPyL.)