Phase III Randomized Multicenter Trial of 68Ga-PSMA-11 PET/CT Molecular Imaging for Prostate Cancer Salvage Radiotherapy Planning [PSMA-SRT]
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 193
- 试验地点
- 4
- 主要终点
- Success rate of salvage radiation therapy (SRT)
研究概览
简要总结
This phase III trial studies how well Gallium Ga 68-labeled PSMA-11 (68Ga-PSMA-11) positron emission tomography (PET)/computed tomography (CT) works in diagnosing participants with prostate cancer that has come back after surgery. 68Ga-PSMA-11 are taken up by cancer cells. Diagnostic procedures, such as PET/CT scans, may help find and diagnose prostate cancer and find out how far the disease has spread. Giving 68Ga-PSMA-11 with PET/CT may help doctors plan better for salvage radiation therapy in participants with recurrent prostate cancer.
详细描述
PRIMARY OBJECTIVE:
I. Success rate of salvage radiation therapy (SRT) measured as biochemical progression-free survival after initiation of SRT.
SECONDARY OBJECTIVES:
I. Sub-group analysis of the primary endpoint (success rate of SRT) within the subgroup with baseline PSA ≥ 0.5 ng/ml II. 5-year biochemical progression-free survival rate (from date of randomization).
III. Metastasis free survival. IV. Initiation of additional salvage therapy after completion of SRT. V. Change in initial treatment intent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histopathology proven prostate cancer.
- •Planned SRT for recurrence after primary prostatectomy.
- •Prostate-specific antigen (PSA) >= 0.1 ng/ml at time of enrollment.
- •Willingness to undergo radiotherapy.
- •Treating radiation oncologist intends to incorporate 68Ga-PSMA-11 PET/CT findings into the radiotherapy plan if patient undergoes 68Ga-PSMA-11 PET/CT.
排除标准
- •Extra-pelvic metastasis on any imaging or biopsy.
- •Androgen deprivation therapy (ADT) within 3 months before 68Ga-PSMA-11 PET/CT.
- •Contraindications to radiotherapy (including active inflammatory bowel disease).
- •Concurrent systemic therapy for prostate cancer with investigational agents.
研究组 & 干预措施
Arm I (standard of care)
Participants receive standard of care SRT.
干预措施: Best Practice (Other)
Arm II (68Ga-PSMA-11 PET/CT)
Participants receive 68Ga-PSMA-11 IV and 50-100 minutes later undergo whole-body (skull base to mid-thighs) PET/CT. Participants then undergo SRT per the discretion of the treating radiation oncologist.
干预措施: Computed Tomography (Procedure)
Arm II (68Ga-PSMA-11 PET/CT)
Participants receive 68Ga-PSMA-11 IV and 50-100 minutes later undergo whole-body (skull base to mid-thighs) PET/CT. Participants then undergo SRT per the discretion of the treating radiation oncologist.
干预措施: Gallium Ga 68-labeled PSMA-11 (Radiation)
Arm II (68Ga-PSMA-11 PET/CT)
Participants receive 68Ga-PSMA-11 IV and 50-100 minutes later undergo whole-body (skull base to mid-thighs) PET/CT. Participants then undergo SRT per the discretion of the treating radiation oncologist.
干预措施: Positron Emission Tomography (Procedure)
结局指标
主要结局
Success rate of salvage radiation therapy (SRT)
时间窗: From date of initiation of SRT assessed up to 5 years
Will be measured as biochemical progression-free survival after initiation of SRT. Will use a log rank test to compare progression free survival time between the two randomized treatment arms.
次要结局
- Biochemical progression-free survival rate(From date of randomization assessed up to 5 years)
- Metastasis free survival(Up to 5 years)
- Change in initial treatment intent(Up to 5 years)
- Initiation of additional salvage therapy after completion of SRT(Up to 5 years)