Duration of Androgen Receptor Pathway Inhibitor and ADT With Metastasis Directed Therapy in Oligometastatic Cancer of the Prostate
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 352
- 试验地点
- 3
- 主要终点
- Progression free survival
研究概览
简要总结
This is a multi-centre, investigator-initiated, three-arm, randomized trial to investigate the addition on androgen receptor pathway inhibitor and atorvastatin to standard of care radiation and hormone therapy improve quality of life.
Participants will either receive standard of care radiation and hormone (ADT) therapy (Arm 1), standard of care radiation and hormone (ADT) therapy plus oral abiraterone for 8-9 months (Arm 3) or standard of care radiation and hormone (ADT) therapy plus oral abiraterone for 8-9 months plus atorvastatin for 2 years (Arm 4). Participants will be routinely follow-up in clinic or remotely for up to 5 years.
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
- •ECOG performance status 0-2
- •Stage IV castrate sensitive metachronous metastatic prostate cancer. diagnosed within 6 months of study enrollment with 1-10 metastases
- •Maximum one metastatic deposit on conventional imaging (CT or bone scan or MR)
- •Additional metastases can be detectable by PSMA PET only
- •All sites of disease are amenable to and can be safely treated with radiotherapy
- •Patients decline continuous use of ADT
排除标准
- •(for all patients):
- •Significant comorbidities rendering patient not suitable for ADT, ARPI (enzalutamide or abiraterone) and SBRT
- •a. Patients with significant comorbidities rendering patient not suitable for atorvastatin is not an exclusion criteria, as these patients can still enroll and be randomized between Arms 1 and
- •History of malignancy within the past 5 years, excluding non-melanoma skin cancer and in-situ cancer, managed non-curatively
- •Prior use of salvage systemic therapy
- •Evidence of spinal cord compression
- •Exclusion Criteria (for Arm 4 only, after randomization)
- •ALT/AST > 3 x ULN
- •History of myasthenia gravis or active myasthenia gravis
- •History of ocular myasthenia or active ocular myasthenia
研究组 & 干预措施
Arm 1 - Standard of Care
Participants in this group will receive standard of care radiation treatment and ADT. Participants will start ADT first. Androgen deprivation therapy will be delivered via injection every 3-4 months as per standard of care (for 8-9 months total). At the same time, or within 3 months of starting ADT, participants will begin radiation treatment. The radiation treatment course will consist of 2-5 sessions of radiation daily or every other day (the number of sessions will be determined by the physician depending on the location of cancer, number of cancer spots, etc.).
干预措施: Standard of Care SBRT and ADT (Other)
Arm 3 - Study Treatment
Participants in this group will receive standard of care radiation treatment and ADT, plus abiraterone. Participants will start ADT first. Androgen deprivation therapy will be delivered via injection every 4 months as per standard of care (for 8 months total). At the same time, or within 3 months of starting ADT, participants will begin radiation treatment. The radiation treatment course will consist of 2-5 sessions of radiation daily or every other day (the number of sessions will be determined by the physician depending on the location of cancer, number of cancer spots, etc.). In addition, participants will take abiraterone orally (by mouth) daily for 8-9 months. Participants will start the first pill within a month of enrollment. This pill can be taken around the same time of day with or without food.
干预措施: Enzalutamide (Drug)
结局指标
主要结局
Progression free survival
时间窗: 5 years
Determine if progression free survival improves with the addition of short-term ARPI (abiraterone or abiraterone) with or without statin (atorvastatin) to standard of care treatment.
次要结局
- Physician-reported toxicity(5 years)
- Patient-reported quality of life(5 years)
- Time to Testosterone Recovery(5 years)
- Improvement in Metabolic Parameters(5 years)
- Circulating Cell-Free DNA(2 years)