Gallium-68 PSMA-11 PET in Patients With Biochemical Recurrence
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 385
- 试验地点
- 1
- 主要终点
- Positive Predictive Value (PPV) on a Per-patient Basis With Histologic Validation
研究概览
简要总结
The investigators are imaging patients with prostate cancer using a new PET imaging agent (Ga-68-PSMA-11) in order to evaluate it's ability to detection prostate cancer in patients with biochemical recurrence after prostatectomy and radiation therapy.
详细描述
Imaging and staging of prostate cancer is critical for surgical and treatment planning. Patients with suspected metastatic prostate cancer will be imaged using Gallium-68 labeled PSMA-11 in order to demonstrate its utility. The investigators plan to utilize this data to obtain further approvals of the Ga-68-PSMA-11 compound, so that this agent will become available for clinical imaging in prostate cancer patients. In the biochemical recurrence population, the primary objective is to determine the sensitivity and positive predictive value (PPV) on a per-patient and per-region-basis of 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy.
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
- •Histopathological proven prostate adenocarcinoma.
- •Rising prostate-specific antigen (PSA) after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy).
- •Post radical prostatectomy (RP) - American Urological Association (AUA) recommendation
- •PSA greater than 0.2 ng/mL measured more than 6 weeks after RP and,
- •Confirmatory persistent PSA greater than 0.2 ng/mL
- •Post-radiation therapy -ASTRO-Phoenix consensus definition
- •Nadir + greater than or equal to 2 ng/mL rise in PSA
- •Karnofsky performance status of greater than 50 (or Eastern Cooperative Oncology Group (ECOG) /World Health Organization (WHO) equivalent).
- •Ability to understand a written informed consent document, and the willingness to sign it.
排除标准
- •Investigational therapy for prostate cancer.
- •Unable to lie flat, still or tolerate a PET scan.
- •Prior history of any other malignancy within the last 2 years, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and superficial bladder cancer.
- •Contraindication to furosemide administration including prior allergy or adverse reaction to furosemide or sulfa drugs. (Note: This exclusion criteria can be removed if Furosemide is omitted as part of the PET imaging protocol if a second-generation scatter correction is available for the used PET device).
研究组 & 干预措施
Ga-68 labeled PSMA-11 PET
PSMA PET imaging: Patients will receive Ga-68 labeled PSMA-11 PET and then undergo PET/CT or PET/MRI approximately 55-70 minutes later.
干预措施: Ga-68 labeled PSMA-11 PET (Drug)
结局指标
主要结局
Positive Predictive Value (PPV) on a Per-patient Basis With Histologic Validation
时间窗: 1 month
PPVs were calculated across the group on a per-patient basis on 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy and reported along with the corresponding two-sided 95% confidence intervals (CI). The CIs were constructed using the Wilson score method.
Positive Predictive Value (PPV) on a Per-region Basis With Histologic Validation
时间窗: 1 month
PPVs were calculated across the group on a per-region-basis on 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy and reported along with the corresponding two-sided 95% CIs. The CIs were constructed using the Wilson score method.
次要结局
- Sensitivity on a Per-patient Basis(1 month)
- Sensitivity on a Per-region Basis(1 month)
- Detection Rates of 68Ga-PSMA-11 PET Stratified by Prostate-specific Antigen (PSA) Value(1 month)
- Inter-reader Agreement Per-region(1 month)
- Percentage of Participants With Change in Clinical Management(Up to 1 year)
- Safety Assessment - Heart Rate(1 day)
- PPVs on a Per-patient of 68Ga-PSMA-11 PET With Conventional Imaging Follow-up(1 month)
- PPVs on a Per-region of 68Ga-PSMA-11 PET With Conventional Imaging Follow-up(1 month)
- Safety Assessment - Blood Pressure(1 day)
研究者
Thomas Hope
Assistant Professor of Radiology and Biomedical Imaging
University of California, San Francisco