A Phase II Trial of PSMA-Directed Para-Aortic Radiation Therapy for Oligorecurrent Prostate Cancer - The OCEAN Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Progression-free Survival (PFS)
研究概览
简要总结
The purpose of this prostate cancer research study is to learn about:
- Improving control of prostate cancer using radiation therapy, delivered to the para-aortic and pelvic lymph nodes, in addition to systemic androgen suppression therapy;
- Preserving quality of life after radiation therapy;
- Leveraging imaging results from prostate-specific membrane antigen (PSMA) positron emission tomography (PET)/computed tomography (CT) scans to evaluate and manage disease progression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Histologically proven prostate adenocarcinoma
- •Male, ≥ 18 years old
- •Oligorecurrent disease limited to the sub-diaphragmatic region with or without pelvic lymph nodes
- •a. No more than a total of 5 lesions on PSMA PET/CT scan (each lesion defined as positive with standardized uptake value (SUV) > liver uptake and CT scan correlate)
- •b. No disease outside of the pelvic and sub-diaphragmatic para-aortic lymph nodes
- •c. At least one lesion in the sub-diaphragmatic pelvic or para-aortic lymph nodes
- •d. Non-bulky nodal disease (ie, tumor <5 cm)
- •Prior pelvic radiation with disease response
- •a. Definitive radiation therapy to the prostate with or without treatment of the pelvic lymph nodes and/or
- •b. Salvage or adjuvant radiation therapy to the prostate bed following prostatectomy with or without treatment of the pelvic lymph nodes
- •Hormone-sensitive prostate cancer
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
- •Ability to understand the investigational nature, potential risks and benefits of the research study, and willingness to sign the written informed consent and HIPAA document(s)
- •Willingness to fill out quality of life and psychosocial forms
- •Willingness to participate in our institution's Prostate Cancer Database Protocol (ID# 20090767)
排除标准
- •No pathological diagnosis of prostate adenocarcinoma
- •Patient has more than 5 sites of metastatic disease
- •Patient has history of bone and/or visceral metastasis
- •No evidence of disease in the para-aortic or pelvic lymph nodes
- •No staging with PSMA PET/CT scan
- •History of prior radiation therapy outside the pelvis for prostate cancer
- •Bulky nodal disease >5 cm in tumor size
- •Androgen deprivation therapy (ADT) or chemotherapy in the three months prior to staging PSMA PET/CT scan (suggesting oligoprogressive disease, rather than true oligorecurrent disease) or at time of study enrollment
- •Suspicious radiologic evidence of disease in the prostate on staging PSMA PET/CT scan without confirmatory negative prostate biopsy
- •Implanted hardware which limits treatment planning or delivery (determined by treating physician)
- •Castration-resistant prostate cancer (history of rising PSA with serum testosterone level <50 ng/dL)
- •Patients with ECOG performance status > 2
- •History of inflammatory bowel disease
- •History of malignancy other than prostate cancer except for non-melanoma skin cancer
- •Patients unable to consent or are prisoners
- •Unwilling to fill out quality of life and psychosocial forms
- •Participants with impaired decision-making capacity
研究组 & 干预措施
PSMA-Guided PA-RT Group
Participants in this group will undergo up to six months of systemic androgen deprivation therapy (ADT) and Androgen receptor signaling inhibitor (ARSI). During system therapy, participants will undergo five weeks of para-aortic radiation therapy.
Total participation duration is up to five years.
干预措施: Androgen Deprivation Therapy (Drug)
PSMA-Guided PA-RT Group
Participants in this group will undergo up to six months of systemic androgen deprivation therapy (ADT) and Androgen receptor signaling inhibitor (ARSI). During system therapy, participants will undergo five weeks of para-aortic radiation therapy.
Total participation duration is up to five years.
干预措施: Androgen Receptor Signaling Inhibitor (Drug)
PSMA-Guided PA-RT Group
Participants in this group will undergo up to six months of systemic androgen deprivation therapy (ADT) and Androgen receptor signaling inhibitor (ARSI). During system therapy, participants will undergo five weeks of para-aortic radiation therapy.
Total participation duration is up to five years.
干预措施: Para Aortic Radiation Therapy: Photon Therapy (Radiation)
PSMA-Guided PA-RT Group
Participants in this group will undergo up to six months of systemic androgen deprivation therapy (ADT) and Androgen receptor signaling inhibitor (ARSI). During system therapy, participants will undergo five weeks of para-aortic radiation therapy.
Total participation duration is up to five years.
干预措施: Para Aortic Radiation Therapy: Proton Therapy (Radiation)
结局指标
主要结局
Progression-free Survival (PFS)
时间窗: Up to 2 years
Progression-free survival (PFS) among participants will be assessed during treatment and clinical follow-up. PFS is defined as the time from start of treatment until any of the following: Biochemical failure, escalation of therapy, radiological evidence of disease progression or death of any cause. Radiological evidence of disease progression will be assessed by the treating physician using the Response Evaluation Criteria in prostate-specific membrane antigen (PSMA) PET/CT (RECIP) version 1.0.
次要结局
- Complete Early Response Rate(Up to 2 years)
- Median Cause Specific Survival(Up to 2 years)
- Proportion of Participants Undergoing Escalation of Therapy(Up to 2 years)
- Change in Quality of Life Scores: EPIC 26 Short Form(Up to 2 years)
- Biochemical Failure-Free Survival (FFS)(Up to 2 years)
- Overall Survival (OS)(Up to 2 years)
- Proportion of Participants Experiencing Cumulative Late Grade ≥ 2 Treatment-Related Toxicity(Up to 2 years)
- Change in Quality of Life Scores: IPSS(Up to 2 years)
- Metastasis-Free Survival(Up to 2 years)
- Change in Quality of Life Scores: HADS(Up to 2 years)
研究者
Benjamin Rich
Assistant Professor of Clinical
University of Miami