Pilot Study to Identify Radiogenomic Biomarkers to Predict Early Treatment Response to Androgen Deprivation Therapy and Radiation Therapy in High Risk Prostate Cancer
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Imaging markers for mid-treatment response
研究概览
简要总结
The purpose of this study is to evaluate the imaging and gene expression biomarkers in prostate cancer. Participants have high-risk prostate cancer and have indicated they will undergo external beam radiation therapy, brachytherapy, and androgen deprivation therapy (EBRT+BTX+ADT). Participants can expect to be in this study for up to 5 years.
详细描述
This is a pilot study to prospectively investigate potential predictive imaging and genomic biomarkers for patients with high-risk prostate cancer treated with standard of care EBRT + BTX + ADT. The primary imaging modalities that will be evaluated will be PSMA positron emission tomography (PET) and multi-parametric magnetic resonance imaging (MRI). Pre-treatment PET/MRI scans will also be obtained as part of standard of care prior to study enrollment. Response will be assessed on a mid-treatment PET/MRI scan obtained for research purposes after completion of EBRT but prior to brachytherapy boost. PET/CT (computerized tomography) may be used instead if PET/MRI is not technically possible. Imaging response will be compared to pathology from image-directed prostate biopsies taken at the time of the brachytherapy boost. The primary genomic marker that will be evaluated is a clinically available gene-expression array, Decipher, that will be obtained as part of standard of care prior to study enrollment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed adenocarcinoma of the prostate
- •Cancer classified as high-risk or very high-risk by National Comprehensive Cancer Network (NCCN) criteria: Grade group ≥4, PSA >20, or primary tumor stage ≥T3a
- •ECOG performance status 0-1
- •Agreed to undergo EBRT, high dose rate (HDR) brachytherapy boost, and 6-36 months of ADT as part of standard of care therapy prior to study enrollment
- •Able to undergo a HDR brachytherapy implant: Pre-radiation IPSS score ≤20 with or without medical management; prostate ≤60 cc as measured by MRI or ultrasound; no prior trans-urethral resection of prostate (TURP); and, median lobe extending into the bladder <1 cm
- •No prior or concurrent malignancy unless disease-free for at least 5 years
排除标准
- •Evidence of regional or distant metastatic disease on pre-treatment bone scan, pelvic MRI, and/or CT of the abdomen/pelvis
- •Prior pelvic radiation therapy
研究组 & 干预措施
EBRT + BTX + ADT, PET and MRI
Standard of care EBRT + BTX + ADT, with mid-treatment PET and MRI (or PET and CT) scans for research.
干预措施: External beam radiation therapy (Radiation)
EBRT + BTX + ADT, PET and MRI
Standard of care EBRT + BTX + ADT, with mid-treatment PET and MRI (or PET and CT) scans for research.
干预措施: Prostate brachytherapy boost (Radiation)
EBRT + BTX + ADT, PET and MRI
Standard of care EBRT + BTX + ADT, with mid-treatment PET and MRI (or PET and CT) scans for research.
干预措施: Androgen deprivation therapy (Drug)
EBRT + BTX + ADT, PET and MRI
Standard of care EBRT + BTX + ADT, with mid-treatment PET and MRI (or PET and CT) scans for research.
干预措施: Positron emission tomography (PET)/magnetic resonance imaging (MRI) (Diagnostic Test)
结局指标
主要结局
Imaging markers for mid-treatment response
时间窗: Mid-treatment (approximately 3 months into treatment)
Evaluate prostate specific membrane antigen (PSMA) PET/MRI for imaging biomarkers that predict mid-treatment response to ADT and EBRT to identify participants at risk for poor response to radiation therapy and ADT.
次要结局
- Evaluate blood-based biomarkers for treatment response.(Baseline and mid-treatment (approximately 3 months into treatment))
- Establish a correlation between PET imaging response and pathologic response(Baseline and mid-treatment (approximately 3 months into treatment))
- Establish a correlation between MRI imaging response and pathologic response(Baseline and mid-treatment (approximately 3 months into treatment))
- Imaging and genomic markers for prostate specific antigen (PSA) recurrence.(Baseline, 3 months post therapy, every 6 months for 5 years)
- Genomic signatures correlated with imaging response(Baseline and mid-treatment (approximately 3 months into treatment))