Prospective Single Center Trial to Compare 68Ga-PSMA-11 and Axumin PET/CT (18F-Fluciclovine) for Restaging Prostate Cancer Patients With Biochemical Recurrence After Radical Prostatectomy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Gallium 68-labeled PSMA-11 ([68]Ga-PSMA-11) and fluciclovine F18 (Axumin) detection rates
研究概览
简要总结
This phase II trial compares how well gallium 68-labeled PSMA-11 positron emission tomography/computed tomography (PET/CT) works compared to fluciclovine F18 PET/CT in imaging participants with prostate cancer after surgery that has come back. PET is an established imaging technique that uses small amounts of radioactivity and CT images provide an exact outline of organs and potential inflammatory tissue where it occurs in the body. Diagnostic procedures, such as PET/CT with gallium 68-labeled PSMA-11, may work better than PET/CT with fluciclovine F18 in helping find out how far the prostate cancer has spread.
详细描述
PRIMARY OBJECTIVES:
I. To compare the detection rates of gallium 68-labeled PSMA-11 ([68]Ga-PSMA-11) PET/CT and fluciclovine F18 (Axumin) PET/CT for the identification of tumor location(s), by patient and region based analysis.
SECONDARY OBJECTIVES:
I. Detection rate on a per-patient basis of (68)Ga-PSMA-11 PET/CT and Axumin PET/CT, stratified by prostate-specific antigen (PSA) value (0.2 - < 0.5; 0.5 - < 1.0; 1.0 - < 2.0).
II. Sensitivity and positive predictive value (PPV) on a per-patient basis, of (68)Ga-PSMA-11 PET/CT and Axumin PET/CT for the detection of tumor location(s), confirmed by histopathology/biopsy and/or clinical and conventional imaging follow-up.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histopathologically proven prostate cancer (PCa)
- •Radical prostatectomy as definitive treatment for PCa
- •Proven biochemical recurrence as defined by American Urological Association (AUA) recommendation: PSA greater than or equal to 0.2 ng/mL measured more than 6 weeks after radical prostatectomy
- •PSA values ranging from 0.2 ng/mL to 2 ng/mL
- •No prior salvage therapies (including salvage radiotherapy and/or salvage lymph node dissection)
- •Axumin PET/CT scan already performed or scheduled as best standard of care procedure for suspected disease relapse within 2 weeks before or after intended 68Ga-PSMA-11 PET/CT
- •Karnofsky performance status of ≥ 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
- •Any change in prostate cancer treatment between Axumin and 68Ga-PSMA PET/CT scan
- •Unable to lie flat, still or tolerate a PET scan
研究组 & 干预措施
Diagnostic ([68]Ga-PSMA-11 PET/CT, Axumin PET/CT)
Participants receive (68)Ga-PSMA-11 IV and 60-90 minutes later, undergo PET/CT imaging over 3 hours. Participants also undergo best standard of care Axumin PET/CT within 2 weeks before or after (68)Ga-PSMA-11 PET/CT.
干预措施: Computed Tomography (Procedure)
Diagnostic ([68]Ga-PSMA-11 PET/CT, Axumin PET/CT)
Participants receive (68)Ga-PSMA-11 IV and 60-90 minutes later, undergo PET/CT imaging over 3 hours. Participants also undergo best standard of care Axumin PET/CT within 2 weeks before or after (68)Ga-PSMA-11 PET/CT.
干预措施: Fluciclovine F18 (Drug)
Diagnostic ([68]Ga-PSMA-11 PET/CT, Axumin PET/CT)
Participants receive (68)Ga-PSMA-11 IV and 60-90 minutes later, undergo PET/CT imaging over 3 hours. Participants also undergo best standard of care Axumin PET/CT within 2 weeks before or after (68)Ga-PSMA-11 PET/CT.
干预措施: Gallium Ga 68-labeled PSMA-11 (Drug)
Diagnostic ([68]Ga-PSMA-11 PET/CT, Axumin PET/CT)
Participants receive (68)Ga-PSMA-11 IV and 60-90 minutes later, undergo PET/CT imaging over 3 hours. Participants also undergo best standard of care Axumin PET/CT within 2 weeks before or after (68)Ga-PSMA-11 PET/CT.
干预措施: Laboratory Biomarker Analysis (Other)
Diagnostic ([68]Ga-PSMA-11 PET/CT, Axumin PET/CT)
Participants receive (68)Ga-PSMA-11 IV and 60-90 minutes later, undergo PET/CT imaging over 3 hours. Participants also undergo best standard of care Axumin PET/CT within 2 weeks before or after (68)Ga-PSMA-11 PET/CT.
干预措施: Positron Emission Tomography (Procedure)
结局指标
主要结局
Gallium 68-labeled PSMA-11 ([68]Ga-PSMA-11) and fluciclovine F18 (Axumin) detection rates
时间窗: Up to 15 months: through data analysis completion (anonymized central imaging read), an estimation of 3 months after enrollment completion.
Will compare rates for the identification of tumor location(s), assessed by patient and region based analysis. This will be calculated and reported along with the corresponding two-sided 95% confidence intervals. The confidence intervals will be constructed using the Wilson score method. Detection rate in the per-participant analysis is defined as number of participants with PET positive disease, independent of pathology or imaging/clinical follow-up. Detection rate in the per-region analysis is defined as number of regions (prostate bed, pelvic lymph-nodes, extra-pelvic lymph-nodes, bone metastases, other soft tissue) resulted PET positive, independent of pathology or imaging/clinical follow-up.
次要结局
- Sensitivity and PPV by-participant and region-based analysis of 68^Ga-PSMA-11 PET and Axumin PET for detection of tumor location(s)(Up to 1 year after completion of PET/CT with 68^Ga-PSMA-11)
- Detection rates on a per-patient basis of 68^Ga-PSMA-11 PET and Axumin PET(Up to 1 year after completion of PET/CT with 68^Ga-PSMA-11)
- Inter-observer (reader) agreement(Up to 15 months: through data analysis completion (anonymized central imaging read), an estimation of 3 months after enrollment completion.)