Intermittent Androgen Deprivation Therapy With or Without Stereotactic Body Radiotherapy for Molecularly Identified Hormone Sensitive Oligometastatic Prostate Cancer: A Randomized Feasibility Study
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Proportion of eligible patients who enroll onto the study
研究概览
简要总结
This study is evaluating whether adding stereotactic radiotherapy (a new, more focused type of radiotherapy) to treat all the tumours that are present will improve outcomes or not compared to drugs alone for patients who are negative on conventional imaging and positive on PSMA PET scan
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
- •Age > 18 years.
- •Able to provide informed consent.
- •Histologic diagnosis of prostate adenocarcinoma.
- •ECOG performance status 0-
- •Stage IV hormone sensitive, synchronous or metachronous oligometastatic prostate cancer as detected by PSMA PET-CT scan with no metastases visible on conventional imaging (CT chest/abdomen/pelvis and bone scan +/- MRI) performed within 3 months of starting ADT.
- •Up to a maximum of 3 PSMA avid areas of metastatic disease.
- •For patients with metachronous disease, there must be a documented PSA rise. For those who had previous prostatectomy, PSA must be > 0.2 ng/mL. For those who had previous radical radiotherapy, PSA must have risen to at least 2 ng/mL above the nadir (Phoenix definition). The primary tumor must be controlled, with no PSMA avid progression within the primary prostate.
- •All sites of disease are amenable to and can be safely treated with SBRT.
排除标准
- •Significant comorbidities rendering patient not suitable for ADT and/or SBRT.
- •History of malignancy within the past 5 years, excluding non-melanoma skin cancer and in-situ cancer.
- •Prior use of salvage or palliative intent ADT. Prior ADT use allowed only if it was delivered neoadjuvantly, concurrently, or adjuvantly with curative-intent treatment to the prostate or prostate bed (for patients with metachronous presentations), and at least 12 months have elapsed.
- •Castrate resistant prostate cancer.
- •Evidence of spinal cord compression.
研究组 & 干预措施
Arm 1: Standard of Care
Intermittent Hormone treatment (minimum of 8 months)
干预措施: Hormone therapy (Drug)
Arm 2: SBRT to mets
Intermittent Hormone treatment (minimum of 8 months)
+ SBRT to all sites of metastatic disease
干预措施: SBRT (Radiation)
Arm 2: SBRT to mets
Intermittent Hormone treatment (minimum of 8 months)
+ SBRT to all sites of metastatic disease
干预措施: Hormone therapy (Drug)
结局指标
主要结局
Proportion of eligible patients who enroll onto the study
时间窗: Through accrual completion, approx 2 years
The primary purpose of this feasibility study is to measure the proportion of patients who are willing to enter this randomized trial
次要结局
- Side Effects and Effectiveness(Through study completion, approx 5 years)