Phase 3 Randomized Trial Of PSMA PET Prior to Definitive Radiation Therapy for Unfavorable Intermediate-Risk or High-Risk Prostate Cancer [PSMA dRT]
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Success rate of definitive radiation therapy (dRT)
研究概览
简要总结
This randomized phase III trial studies the success rate of definitive radiation therapy (dRT) for prostate cancer (PCa) with or without planning based on PSMA PET. PSMA- PET-based dRT, may improve radiation therapy planning and patient selection for dRT, and potentially improve its outcome compared to dRT without PSMA PET (standard dRT).
详细描述
PRIMARY OBJECTIVE:
I. To compare the outcome of patients with unfavorable intermediate (IR) and high-risk (HR) prostate cancer (PCa) after standard dRT versus prostate-specific membrane antigen (PSMA) positron emission tomography (PET)-based dRT.
OUTLINE: Patients are randomized to 1 of 2 arms. In both arms, no other primary treatment should be given before RT.
Arm I: Patients do not undergo PSMA PET for dRT planning. Patients undergo standard of care dRT at the discretion of the treating radiation oncologist.
Arm II: Patients undergo PSMA PET for dRT planning. Patients then undergo dRT at the discretion of the treating radiation oncologist, who receives the PSMA PET result and images.
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
- 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
- •Adult male 18 years or older
- •Histopathologically-proven PCa
- •Unfavorable IR to HR disease:
- •Prostate specific antigen (PSA) >= 10 ng/mL
- •Or cT-stage >= 2b
- •Or Gleason grade 3 (4+3=7) or higher
- •Or Gleason grade 2 (3+4=7) AND >= 50% positive biopsy cores
- •Or Decipher Score >= 0.45
- •Treating radiation oncologist intends to incorporate PSMA PET findings into the radiotherapy plan, if patient undergoes PSMA PET (intervention arm 2)
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
排除标准
- •Less than 18 years old at the time of investigational product administration
- •Extra-pelvic metastasis (M1 disease) on any imaging or biopsy done before randomization
- •Prior PSMA PET
- •Prior pelvic RT
- •Contraindications to radiotherapy (including active inflammatory bowel disease)
- •Concurrent or prior surgery or systemic therapy for PCa at the time of randomization
结局指标
主要结局
Success rate of definitive radiation therapy (dRT)
时间窗: From date of randomization to first occurrence of progression, assessed up to 5 years
Will be measured as progression-free survival after initiation of dRT. Progression is defined as (whichever occurs first): A biochemical recurrence defined as a rise by 2 ng/mL or more above the nadir prostate specific antigen (PSA) (defined as the lowest PSA achieved) after radiotherapy with or without short-term hormonal therapy, appearance of metastasis or loco-regional recurrence (diagnosed by any imaging or biopsy), initiation of any new salvage therapy or death from any cause. Survival curves will be constructed using the Kaplan-Meier method.
次要结局
- Metastasis-free survival after initiation of radiation therapy (RT)(Up to 5 years after the date of randomization)
- Overall survival(Up to 5 years after the date of randomization)
- PSMA PET derived predictors of overall survival(Up to 5 years after the date of randomization)
- PSMA positron emission tomography (PET) derived predictors of progression-free survival(Up to 5 years after the date of randomization)
- Change in initial treatment intent(Baseline up to 5 years after the date of randomization)
- Loco-regional progression free survival(Up to 5 years after the date of randomization)