Stereotactic Body Radiotherapy or Standard of Care for Prostate Oligoprogressive Cancer: a Randomized Phase II Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Study Feasibility
研究概览
简要总结
This is a single centre, interventional, randomized Phase II, two-arm prospective trial investigating if Stereotactic Body Radiotherapy (SBRT) to all sites of Oligopressive (OP) disease while remaining on current Systemic Therapy (ST) will improve biochemical control compared to Standard of Care (SoC) (which involves a change in ST) for patients with OP Castrate Resistance Prostate Cancer (CRPC).
详细描述
The current standard of care for patients with metastatic Oligopressive (OP) Castrate Resistance Prostate Cancer (CRPC) is a change in Systemic Therapy (ST). We propose that Stereotactic Body Radiotherapy (SBRT) to Oligopressive sites, while maintaining patients on their current Systemic Therapy, may allow for biochemical control of disease while maintaining patient Quality of Life and avoiding the toxicities associated with changing Systemic Therapy. We have proposed an initial prospective feasibility study, followed by a larger phase II prospective study to investigate the efficacy of SBRT in Oligopressive Castrate Resistance Prostate Cancer.
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 100 Years（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
- •Castrate Resistance Prostate Cancer
- •Radiographic evidence of <10 sites of extra-cranial OP metastatic lesions
- •Receiving any line of ST for >3 months
- •All sites of OP disease are amenable to and can be safely treated with SBRT
- •ECOG performance status 0-3
排除标准
- •Evidence of spinal cord compression
- •Contraindication to radiotherapy
研究组 & 干预措施
Arm 1 - Standard of Care
Participants on Arm 1 - SOC will be treated as per standard of care by their treating Oncologist. In most instances, it is anticipated participants will undergo a change in Systemic Therapy (ST) (including best supportive care). The ST will be at the discretion of the Oncologist and patient, according to best practices for the patient's diagnosis and clinical scenario. Patients can receive palliative radiotherapy for standard indications at any time.
干预措施: Stereotactic Body Radiation Therapy (SBRT) (Radiation)
Arm 1 - Standard of Care
Participants on Arm 1 - SOC will be treated as per standard of care by their treating Oncologist. In most instances, it is anticipated participants will undergo a change in Systemic Therapy (ST) (including best supportive care). The ST will be at the discretion of the Oncologist and patient, according to best practices for the patient's diagnosis and clinical scenario. Patients can receive palliative radiotherapy for standard indications at any time.
干预措施: Systemic therapy (Other)
Arm 2 - Experimental
Participants on Arm 2 - Experimental will receive standard of care SBRT to oligoprogressive sites according to institutional standards while remaining on the systemic treatment prescribed by the treating oncologist.
干预措施: Stereotactic Body Radiation Therapy (SBRT) (Radiation)
Arm 2 - Experimental
Participants on Arm 2 - Experimental will receive standard of care SBRT to oligoprogressive sites according to institutional standards while remaining on the systemic treatment prescribed by the treating oncologist.
干预措施: Systemic therapy (Other)
结局指标
主要结局
Study Feasibility
时间窗: Within 18 months of study activation.
Determine the feasibility of enrolling 21 patients patients onto a study randomizing patients to either MDT using SBRT plus remaining on current ST versus SoC (change in Systemic Therapy) by measuring the rate accrual (number of patients per month for 18 months).
Change in Prostate-Specific Antigen (PSA)
时间窗: Enrollment to 12 months post-enrollment.
Assess by standard PSA blood testing if the proportion of patients having a \>50% change in PSA compared to baseline (PSA50) is improved with MDT using SBRT plus remaining on current ST versus SoC.
次要结局
- Time to next Systemic Therapy(Enrollment to 12-months post-enrollment.)
- Radiographic Local Control of Oligopressive Lesions(Enrollment to 12 months-post enrollment.)
- Radiographic Distant Control of Oligopressive Lesions(Enrollment to 12-months post-enrollment.)
- Differences in Toxicity(Enrollment to 12-months post-enrollment.)
- Progression Free Survival (PFS)(Enrollment to 12-months post-enrollment.)
- Differences in Quality of Life(Enrollment to 12-months post-enrollment.)