68Ga-PSMA-11 PET in Patients With Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 141
- 试验地点
- 1
- 主要终点
- Change in planned management strategy
研究概览
简要总结
This trial studies how well 68Ga-PSMA-11 PET scan works in imaging patients with prostate cancer. Diagnostic procedures, such as 68Ga-PSMA-11 PET may find and diagnose prostate cancer and improve monitoring of treatment response.
详细描述
OUTLINE:
Patients receive gallium Ga 68-labeled PSMA-11 intravenously (IV) over 60-75 minutes then undergo PET/CT or PET/magnetic resonance (MR) scan over 2-4 minutes per bed position at baseline. Patients receiving systemic therapy undergo an additional 68Ga-PSMA-11 PET/CT or PET/MR scan 12 weeks after initiating therapy. Patients may also undergo CT and bone scan during screening and on study.
After the completion of study, patients are followed up at 60 days, 6 months, and annually up to 5 years or until time of first progression.
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
- •Pathologically proven prostate adenocarcinoma
- •For the initial staging arm (initial staging cohort), high risk characteristics, including any of the following:
- •Grade group 4-5 and/or
- •PSA > 20 ng/mL
- •For patients with biochemical recurrence (biochemical recurrence cohort):
- •Rising PSA after definitive therapy with prostatectomy or targeted local therapy (including but not limited to external beam radiation therapy, brachytherapy, high-frequency ultrasound, and cryotherapy)
- •If post-radical prostatectomy, PSA > 0.2 ng/mL measured > 6 weeks post-operatively and confirmatory persistent PSA greater than 0.2 ng/mL (American Urological Association (AUA) definition for biochemical recurrence
- •If post-radiation therapy, PSA that is equal to, or greater than, a 2 mg/mL rise above PSA nadir (American Society of Radiation Oncology (ASTRO) definition for biochemical recurrence)
- •For patients undergoing systemic therapy (treatment monitoring cohort):
- •Diagnosis of metastatic castration-resistant prostate cancer
- •At least one or more measurable ( > 1 cm diameter in short axis) or evaluable lesions by any modality obtained within the past 60 days
- •Planned for treatment with standard of care androgen receptor pathway inhibitor or chemotherapy
- •This can include patients who have already undergone a standard of care Ga-68 PSMA PET/CT or PET/MR for determining eligibility for Lu-177 PSMA therapy, for whom the PET/CT or PET/MR did not confirm eligibility for treatment with Lu-177 PSMA, and who are planned to start treatment on chemotherapy or androgen receptor signaling inhibitor (ARSI) within 30 days of the Ga-68 PSMA PET. This can also include patients who have obtained a standard of care Ga-68 PSMA PET/CT or PET/MR for rising PSA to help with restaging prior to starting new treatment with ARSI or chemotherapy, even if Lu-177 PSMA is not being considered at that time. Scan 1 must be completed within 30 days of enrollment. Any patient with an equivocal lesion by conventional imaging, regardless of where they are in the course of evaluation or treatment (equivocal lesion cohort)
- •No other malignancy within the past 2 years (with the exception of skin basal cell or cutaneous superficial squamous cell carcinoma, superficial bladder cancer, carcinoma in situ in any location, or Rai Stage 0 chronic lymphocytic leukemia, which are allowed)
- •Eastern Cooperative Oncology Group/World Health Organization (ECOG/WHO) performance status grades 0, 1, or 2
- •Ability to understand and willingness to provide informed consent
排除标准
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
研究组 & 干预措施
Diagnostic (Gallium Ga 68-labeled PSMA-11, PET/CT, PET/MR)
Patients receive gallium Ga 68-labeled PSMA-11 IV over 60-75 minutes then undergo PET/CT or PET/MR scan over 2-4 minutes per bed position at baseline. Patients receiving systemic therapy undergo an additional 68Ga-PSMA-11 PET/CT or PET/MR scan 12 weeks after initiating therapy. Patients may also undergo CT and bone scan during screening and on study.
干预措施: Computed Tomography (Procedure)
Diagnostic (Gallium Ga 68-labeled PSMA-11, PET/CT, PET/MR)
Patients receive gallium Ga 68-labeled PSMA-11 IV over 60-75 minutes then undergo PET/CT or PET/MR scan over 2-4 minutes per bed position at baseline. Patients receiving systemic therapy undergo an additional 68Ga-PSMA-11 PET/CT or PET/MR scan 12 weeks after initiating therapy. Patients may also undergo CT and bone scan during screening and on study.
干预措施: Gallium Ga 68 Gozetotide (Drug)
Diagnostic (Gallium Ga 68-labeled PSMA-11, PET/CT, PET/MR)
Patients receive gallium Ga 68-labeled PSMA-11 IV over 60-75 minutes then undergo PET/CT or PET/MR scan over 2-4 minutes per bed position at baseline. Patients receiving systemic therapy undergo an additional 68Ga-PSMA-11 PET/CT or PET/MR scan 12 weeks after initiating therapy. Patients may also undergo CT and bone scan during screening and on study.
干预措施: Positron Emission Tomography (Procedure)
Diagnostic (Gallium Ga 68-labeled PSMA-11, PET/CT, PET/MR)
Patients receive gallium Ga 68-labeled PSMA-11 IV over 60-75 minutes then undergo PET/CT or PET/MR scan over 2-4 minutes per bed position at baseline. Patients receiving systemic therapy undergo an additional 68Ga-PSMA-11 PET/CT or PET/MR scan 12 weeks after initiating therapy. Patients may also undergo CT and bone scan during screening and on study.
干预措施: Magnetic Resonance Imaging (Procedure)
Diagnostic (Gallium Ga 68-labeled PSMA-11, PET/CT, PET/MR)
Patients receive gallium Ga 68-labeled PSMA-11 IV over 60-75 minutes then undergo PET/CT or PET/MR scan over 2-4 minutes per bed position at baseline. Patients receiving systemic therapy undergo an additional 68Ga-PSMA-11 PET/CT or PET/MR scan 12 weeks after initiating therapy. Patients may also undergo CT and bone scan during screening and on study.
干预措施: Bone Scan (Procedure)
Diagnostic (Gallium Ga 68-labeled PSMA-11, PET/CT, PET/MR)
Patients receive gallium Ga 68-labeled PSMA-11 IV over 60-75 minutes then undergo PET/CT or PET/MR scan over 2-4 minutes per bed position at baseline. Patients receiving systemic therapy undergo an additional 68Ga-PSMA-11 PET/CT or PET/MR scan 12 weeks after initiating therapy. Patients may also undergo CT and bone scan during screening and on study.
干预措施: Electronic Health Record Review (Other)
结局指标
主要结局
Change in planned management strategy
时间窗: Baseline up to 1.5 years after the last scan
Assessed using conventional imaging with executed management strategy incorporating information from first (scan 1) 68Ga-prostate-specific membrane antigen (PSMA)-11 positron emission tomography (PET)/computed tomography (CT), regardless of treatment modality. Will be expressed as the percentage of total patients imaged in which change in management occurred, regardless of treatment modality. The rate of change in management will also be estimated within each group (initial staging, biochemical recurrence, and equivocal lesion cohorts). 95% confidence intervals (CIs) will be used to express precision of the estimates.
次要结局
- Major change in management(Baseline up to 5 years post-scan)
- Minor change in management(Baseline up to 5 years post-scan)
- 68Ga-PSMA-11 standardized uptake value maximum (SUVmax)(Up to 6 weeks after systemic therapy initiation)
- 68Ga-PSMA-11 standard uptake value normalized to lean body mass (SULpeak)(Up to 6 weeks after systemic therapy initiation)
- Change in 68Ga-PSMA-11 SUVmax(Baseline up to 6 weeks after systemic therapy initiation)
- Change in 68Ga-PSMA-11 SULpeak(Baseline up to 6 weeks after systemic therapy initiation)
- Change in size of measurable metastatic lesions(Baseline up to 5 years post-scan)
- Histopathologic demonstration of prostate cancer within biopsy or surgical resection specimens(Up to 5 years post-scan)
- Change in PSMA total tumor volume(Baseline up to 5 years post-scan)