Collection and Measurement of Blood and Imaging Biomarkers in Patients Undergoing Standard Primary and Postoperative Radiotherapy for Prostatic Neoplasms - The Miami CoMBINe Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Comparison of Pre- and Post-Treatment Quantitative Imaging Parameters to Changes in Circulating Tumor Cells Over Time in Study Participants.
研究概览
简要总结
The purpose of this research study is to learn about: 1) How standard radiation treatment to prostate (primary radiotherapy) or the pelvis after prostatectomy (postoperative radiotherapy) may cause changes in MRI and PET imaging traits that might be used in the future to predict response. 2) Comparison of such MRI and PET imaging traits with the number of circulating tumor cells (CTCs) present in the blood prior to treatment and the changes in these counts after treatment. 3) How MRI and PET imaging characteristics and changes are related to the expression of genes in the cancer tissue obtained before treatment from prostate biopsy or a prior prostatectomy before treatment. 4) How the response of prostate cancer treatment relates to the imaging and CTC changes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Pathologic confirmation of prostate cancer.
- •Any T-stage.
- •By imaging or clinical criteria, any patient with disease staging of N0/N1 and M0/M
- •Patients with metastatic disease are encouraged to participate.
- •Any Gleason Score will be eligible.
- •Androgen deprivation therapy (ADT) is at the discretion of the treating physician, but must be declared as none, short-term, long-term, or extended prior to enrollment. The length is calculated from the LHRH (agonist injection). If ADT is planned (based on treating physician preference), the following restrictions apply:
- •Short term ADT is defined as ≤ 7 months;
- •Long term ADT is defined as > 7 months and ≤ 36 months;
- •Extended ADT is defined as >36 months (e.g., M1 patients).
- •Prostate-specific antigen (PSA) ≤100 ng/mL within (+/-) 4 months of signing of consent. If PSA was above 100 and drops to <100 with antibiotics, this is acceptable for enrollment.
- •No previous pelvic radiotherapy.
- •The ability to understand and the willingness to sign a written informed consent document
- •Zubrod performance status ≤ 2 (Karnofsky or ECOG performance status may be used to estimate Zubrod):
- •Age ≥ 30 at signing of consent.
- •Subjects must be planned to receive radiation therapy or to undergo prostatectomy.
- •Subjects treated primarily with RT are recommended to have had an MUFgBx prior to radiation treatment.
排除标准
- 未提供
研究组 & 干预措施
Radiation Therapy Group
Participants with prostate cancer diagnosis who are scheduled to undergo radiotherapy (definitive or palliative) with or without the addition of Androgen Deprivation Therapy (ADT) will be evaluated
Prostatectomy Group
Participants with prostate cancer diagnosis who are scheduled to undergo prostatectomy will be evaluated.
结局指标
主要结局
Comparison of Pre- and Post-Treatment Quantitative Imaging Parameters to Changes in Circulating Tumor Cells Over Time in Study Participants.
时间窗: Baseline, within 8 Days Prior to End of RT, 3 months Post-RT, 9 months and 2-2.5 Years Post-RT
Pre-Treatment and Post-Treatment quantitative imaging parameters will be associated with circulating tumor cell (CTC) changes over time in prostate cancer (PCa) patients who receive treatment with RT ± androgen deprivation therapy (ADT) or prostatectomy per standard of care. CTC and quantitative imaging changes will be determined at each of the planned research acquisition time points (8 days prior to completion of radiation therapy (RT), 3 months post-RT, 9 months post-RT, and 2-2.5 years post-treatment) comparing to the Baseline.
次要结局
- Relationship of Androgen Deprivation Therapy (ADT) status to quantitative imaging features and/or CTC levels in patients(Between Baseline and 2-2.5 Years Post-RT)
- Comparison of changes in CTCs to endpoint prostate research biopsy status.(Between Baseline and 2-2.5 Years Post-RT)
- Comparison of changes in quantitative imaging characteristics to endpoint prostate research biopsy status.(Between Baseline and 2-2.5 Years Post-RT)
- Relationship of CTC changes and/or quantitative imaging parameter changes to patient outcome (biochemical and clinical disease failure).(Between Baseline and 2-2.5 Years Post-RT)
- Relationship of quantitative imaging characteristics and/or CTC changes with other tissue biomarkers obtained from the pre-treatment MRI ultrasound (US) fusion guided prostate biopsy or prostatectomy tissue in those treated primarily.(Between Baseline and 2-2.5 Years Post-RT)
- Comparison of changes in gene expression patterns to endpoint prostate research biopsy status.(Between Baseline and 2-2.5 Years Post-RT)
- Determination of the added value of PET/CT using newer tracers to MRI(Between Baseline and 2-2.5 Years Post-RT)
研究者
Alan Pollack, MD, PhD
Professor
University of Miami