Phase 2 Randomized Total Eradication of Metastatic Lesions Following Definitive Radiation to the Prostate in de Novo oligometaStatic Prostate Cancer (TERPS) Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 122
- 试验地点
- 19
- 主要终点
- To determine the 2-year failure-free survival (FFS) of men who have oligometastatic prostate cancer with BST+XRT versus BST+XRT+SABR MDT.
研究概览
简要总结
This research is being done to see if we can improve the outcome of prostate cancer patients who present with metastatic lesions at initial diagnosis.
详细描述
This study will compare the effects, good and/or bad, of using the standard of care treatment (systemic therapy + primary prostate radiation) compared to standard of care treatment plus stereotactic ablative radiation therapy (SABR) to metastatic lesions for prostate patients. The researchers are also trying to learn if the addition of SABR will affect recurrence rates. Presence of circulating tumor cells, gut bacteria, and quality of life will be assessed for both groups.
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
- •Patient must have at least one and up to three asymptomatic metastatic tumor(s) of the bone or soft tissue (with at least one bone metastasis) develop within the past 6-months that are seen on imaging. Up to five lesions are allowed on advanced functional imaging such as fluciclovine (Axumin), choline or PSMA PET-CT scan.
- •CT or MRI scan within 6 months of enrollment
- •Bone scan within 6 months of enrollment
- •Fluciclovine (Axumin), choline, or PSMA PET-CT scan within 6 months of enrollment (PET-CT scan is reasonable for study entry imaging as an alternative to CT/MRI scan and bone scan)
- •Histologic confirmation of malignancy (primary or metastatic tumor).
- •Patient may have had prior systemic therapy and/or ADT associated with treatment within 9-months of enrollment.
- •PSA > 0.5 but <
- •Patient must be ≥ 18 years of age.
- •Patient must have a life expectancy ≥ 12 months.
- •Patient must have an ECOG performance status ≤
- •Patient must have the ability to understand and the willingness to sign a written informed consent document
排除标准
- •Castration-resistant prostate cancer (CRPC).
- •Prior radiation therapy to an overlapping site of a target lesion that would preclude further radiation therapy
- •Spinal cord compression or impending spinal cord compression.
- •Suspected pulmonary and/or liver metastases (greater >10 mm in largest axis).
- •Patient receiving any other investigational agents.
- •Inability to receive any form of systemic therapy in the opinion of a treating medical oncologist .
- •Unable to lie flat during or tolerate PET/MRI, PET/CT or SABR.
- •No radiographical evidence of cranial metastasis.
- •Refusal to sign informed consent.
研究组 & 干预措施
Best systemic therapy (BST) + primary prostate radiation (XRT)
干预措施: Prostate radiation (XRT) (Radiation)
Best systemic therapy (BST) + primary prostate radiation (XRT)
干预措施: Systemic Therapy (Drug)
BST + XRT + SABR metastasis-directed therapy (MDT)
干预措施: Prostate radiation (XRT) (Radiation)
BST + XRT + SABR metastasis-directed therapy (MDT)
干预措施: Systemic Therapy (Drug)
BST + XRT + SABR metastasis-directed therapy (MDT)
干预措施: Stereotactic ablative radiation therapy (SABR) (Radiation)
结局指标
主要结局
To determine the 2-year failure-free survival (FFS) of men who have oligometastatic prostate cancer with BST+XRT versus BST+XRT+SABR MDT.
时间窗: 2 years
Cross-over to the SABR MDT is allowed following failure.
次要结局
- To determine the number of participants with toxicities related to SABR MDT in patients with de novo oligometastatic disease(5 years)
- To determine local control at 12-months after SABR MDT in patients with de novo oligometastatic disease.(1 year)
- Quality of life assessed through EPIC tool utilizing patient scores in each function group following completion of SABR MDT.(5 years)
- To assess time to progression(5 years)
研究者
Department of Radiation Oncology
Principal Investigator
University of Maryland, Baltimore