Evaluation of Treatment Response Using Multiparametric MRI After Prostate Radiotherapy
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 120
- 试验地点
- 15
- 主要终点
- characterize the changes in tumor characteristics by functional imaging changes with post-treatment prostate biopsy outcomes
研究概览
简要总结
The purpose of this study is to better understand prostate cancer changes after radiation treatment, through magnetic resonance imaging (MRI). MRI is an imaging test that allows doctors to see prostate gland without any operation procedures. It can help identifying the tumors in the prostate. For patients with newly diagnosed prostate cancer, MRI may help doctors manage treatment better and sooner.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Patients with biopsy proven (completed and/or reviewed at MSK) adenocarcinoma of the prostate, who will undergo external beam radiotherapy using conventional fractionation IGRT including moderate hypofractionated radiation, low rate brachytherapy alone, brachytherapy (either high dose or low dose) combined with supplemental image guided radiation (including IGRT, EBRT, and SBRT), SBRT, or proton radiotherapy.
- •Age ≥ 18 years old
- •Baseline MP-MRI, which is obtained at MSKCC Main Campus on the 3-Tesla Philips MRI unit as part of the standard (clinical) staging assessment demonstrates at least one dominant or visible lesion which measures > 0.5 cm in maximum axial diameter as assessed on T2-weighted images.
- •No prior history of androgen deprivation therapy within the last month. However patients who will receive neoadjuvant and concurrent and adjuvant hormonal therapy will be eligible.
- •Willing to come to MSK Main Campus for baseline and follow-up MP-MRIs.
排除标准
- •History of radical prostatectomy
- •Patients who are unwilling or unable to undergo MRI including patients with contraindications to MRI such as the presence of cardiac pacemakers or non-compatible intracranial vascular clips, claustrophobia, inability to lie flat for the duration of the study etc.
- •Patients with a metallic hip implant, metallic implant or device in the pelvis or ferromagnetic fiducial beacons (Calypso) that might distort local magnetic field and compromise quality of MP-MRI
- •Patients in which gadolinium contrast is contra-indicated.
- •Metastatic disease
研究组 & 干预措施
Multiparametric MRI
Patients undergo baseline standard (clinical) MP-MRI prior to therapy (ADT or RT). After completion of radiotherapy, follow-up MRIs will be obtained using the same 3T Philips MRI unit at approximately 3, 6, 12, 18 & 24 (+/- 4 weeks) months after radiotherapy. A standard post-tx biopsy will be performed at 24 months (+/- 4 weeks) after therapy which will serve to define the local control status after therapy. Local control based on this biopsy will be interpreted as negative or adenoca with severe tx effect; a positive biopsy will be a specimen which demonstrates adenocarcinoma that can be classified with a Gleason score as we have previously reported.
干预措施: multi-parametric MRI(MP-MRI) (Device)
Multiparametric MRI
Patients undergo baseline standard (clinical) MP-MRI prior to therapy (ADT or RT). After completion of radiotherapy, follow-up MRIs will be obtained using the same 3T Philips MRI unit at approximately 3, 6, 12, 18 & 24 (+/- 4 weeks) months after radiotherapy. A standard post-tx biopsy will be performed at 24 months (+/- 4 weeks) after therapy which will serve to define the local control status after therapy. Local control based on this biopsy will be interpreted as negative or adenoca with severe tx effect; a positive biopsy will be a specimen which demonstrates adenocarcinoma that can be classified with a Gleason score as we have previously reported.
干预措施: dynamic contrast-enhanced MRI (DCE) (Device)
Multiparametric MRI
Patients undergo baseline standard (clinical) MP-MRI prior to therapy (ADT or RT). After completion of radiotherapy, follow-up MRIs will be obtained using the same 3T Philips MRI unit at approximately 3, 6, 12, 18 & 24 (+/- 4 weeks) months after radiotherapy. A standard post-tx biopsy will be performed at 24 months (+/- 4 weeks) after therapy which will serve to define the local control status after therapy. Local control based on this biopsy will be interpreted as negative or adenoca with severe tx effect; a positive biopsy will be a specimen which demonstrates adenocarcinoma that can be classified with a Gleason score as we have previously reported.
干预措施: biopsy (Procedure)
结局指标
主要结局
characterize the changes in tumor characteristics by functional imaging changes with post-treatment prostate biopsy outcomes
时间窗: at 24 months after completion of radiotherapy
This change will then be correlated with the biopsy outcome (binary) by two sample t-tests.
次要结局
未报告次要终点