Advanced PET-CT Directed Post-Prostatectomy Radiotherapy to Enhance Prostate Cancer Outcomes
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 140
- 试验地点
- 3
- 主要终点
- Percentage of Participants Disease-Free at 2 Years
研究概览
简要总结
This phase II trial studies how well a positron emission tomography (PET)/computed tomography (CT) scan using fluciclovine F18 compared with a PET/CT scan with 68Ga-PSMA works in planning radiation treatments and enhancing outcomes in patients with prostate adenocarcinoma. Fluciclovine F18 and 68Ga-PSMA are types of tracers, called radiotracers, that are injected and can accumulate in tumor cells to develop images of them during a PET/CT scan. It is not yet known whether giving fluciclovine F18 or 68Ga-PSMA may work better in planning radiation treatments and enhancing outcomes in patients with prostate adenocarcinoma.
详细描述
PRIMARY OBJECTIVES
I. Improve the outcomes of post-prostatectomy radiotherapy prostate cancer patients via selection and treatment optimization with advanced molecular imaging with dose escalation.
II. Establish the role of advanced molecular imaging with fluciclovine F18 (fluciclovine [18F]) and gallium Ga68-labeled prostate specific membrane antigen PSMA-11 (68Ga-PSMA) PET/CT in influencing post-prostatectomy radiotherapy decision-making.
III. Establish the role of advanced molecular imaging with fluciclovine 18F or 68Ga-PSMA in altering radiotherapy treatment volumes.
OUTLINE: Patients are randomized to 1 of 2 arms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Adenocarcinoma of the prostate, post radical-prostatectomy
- •Detectable prostate-specific antigen (PSA)
- •Eastern Cooperative Oncology Group (ECOG)/Zubrod performance status of 0-2
- •No definitive findings for skeletal metastasis on technetium 99-m methyl diphosphonate (MDP) or F-18 PET bone scan
- •No definitive findings of systemic (extrapelvic) metastasis on CT and/or magnetic resonance (MR) scan of abdomen and pelvis
- •Willingness to undergo pelvic radiotherapy
排除标准
- •Contraindications to radiotherapy (including active inflammatory bowel disease or prior pelvic radiotherapy)
- •Inability to undergo fluciclovine or Ga-PSMA PET-CT
- •Definitive findings of systemic metastasis on conventional imaging or biopsy
- •Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years
- •Severe acute co-morbidity, defined as follows:
- •Unstable angina and/or congestive heart failure requiring hospitalization in the last 3 months
- •Transmural myocardial infarction within the last 6 months
- •Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
- •Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
- •Acquired immune deficiency syndrome (AIDS) based upon current Center for Disease Control (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements may also exclude immunocompromised patients
研究组 & 干预措施
Arm I (fluciclovine F18, PET/CT)
Patients receive fluciclovine F18 IV and undergo positron emission tomography (PET)/computed tomography (CT) over 30 minutes.
干预措施: Computed Tomography (Procedure)
Arm I (fluciclovine F18, PET/CT)
Patients receive fluciclovine F18 IV and undergo positron emission tomography (PET)/computed tomography (CT) over 30 minutes.
干预措施: Positron Emission Tomography (Procedure)
Arm II (68Ga-PSMA, PET/CT)
Patients receive gallium Ga68-labeled PSMA-11 IV, wait 60 minutes, then undergo positron emission tomography (PET)/computed tomography (CT) over 30 minutes.
干预措施: Computed Tomography (Procedure)
Arm II (68Ga-PSMA, PET/CT)
Patients receive gallium Ga68-labeled PSMA-11 IV, wait 60 minutes, then undergo positron emission tomography (PET)/computed tomography (CT) over 30 minutes.
干预措施: Positron Emission Tomography (Procedure)
Arm II (68Ga-PSMA, PET/CT)
Patients receive gallium Ga68-labeled PSMA-11 IV, wait 60 minutes, then undergo positron emission tomography (PET)/computed tomography (CT) over 30 minutes.
干预措施: Gallium Ga68-labeled PSMA-11 (Radiation)
Arm I (fluciclovine F18, PET/CT)
Patients receive fluciclovine F18 IV and undergo positron emission tomography (PET)/computed tomography (CT) over 30 minutes.
干预措施: Fluciclovine F18 (Drug)
结局指标
主要结局
Percentage of Participants Disease-Free at 2 Years
时间窗: Up to 2 years after study start
A survival analysis will be conducted on disease-free survival (DFS). The survivor functions for DFS will be estimated with Kaplan and Meier method and plotted. The logrank test will be used to test the difference in DFS of (a) both arms in aggregate with the survivor function on our prior R01 trial and (b) between the two study arms.
次要结局
- Decision to Offer Radiotherapy(Baseline (pre-PET treatment) and final treatment decision (post-PET), up to 4 weeks)
- Decision to Treat Pelvic Nodes(Baseline (pre-PET treatment) and final treatment decision (post-PET), up to 4 weeks)
- Decision to Boost Between the Initial and Final Treatment Decisions(Baseline (pre-PET treatment) and final treatment decision (post-PET), up to 4 weeks)
- Prostate Bed and Pelvis Clinical Target Volume (CTV) and Planning Target Volume (PTV)(Baseline (pre-PET treatment) and final treatment decision (post-PET), up to 4 weeks)
- Quality of Life: Dose Volume Histogram (DVH) of the Rectum (Percentage of Rectum Receiving 65 Gy (Rectum V65), and 40 Gy (Rectum V40))(Up to 4 weeks post-treatment)
- Quality of Life: Dose Volume Histogram (DVH) of the Bladder (Percentage of Bladder Receiving 65 Gy (Bladder V65), and 40 Gy (Bladder V40))(Up to 4 weeks post-treatment.)
研究者
Ashesh B Jani
Principal Investigator
Emory University