Monitoring Prostate Cancer Tumor Response to Radiation Therapy Using Advanced Functional Magnetic Resonance Imaging (MRI) and Pylarify (18F-DCFPyL) PSMA Positron Emission Tomography (PET)
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 入组人数
- 30
- 主要终点
- Difference from baseline (pre-treatment) to end of treatment scans for each patient in molecular/metabolic MRI to second brachytherapy treatment
研究概览
简要总结
This is a voluntary research study to find out how using technology including advanced magnetic resonance imaging (MRI) and prostate-specific membrane antigen - positron emission tomography (PSMA-PET) scan imaging, in addition to combined prostate treatment using radiation therapy, brachytherapy (internal radiation treatment using small radioactive seeds placed inside the body) and androgen deprivation therapy (drug therapy to suppress hormones) can help doctors see, track and predict tumor response to treatment for prostate cancer patients. Participation in this study will consist of radiation planning and simulation, magnetic resonance imaging (MRI) and positron emission tomography and computed tomography scan (PET/CT). One MRI and PSMA PET/CT scan will be done prior to the start of first external beam radiation therapy (EBRT) fraction. At mid-treatment prior to the second brachytherapy fraction, an MRI and PSMA PET/CT will be done. A third scan will be performed after 75% testosterone recovery or 12 months post androgen deprivation therapy (ADT) [whichever comes first].
详细描述
The goal of the study is to better understand how an individual tumor responds to radiation therapy and determine if advanced imaging can be used for prognostic purposes, especially to predict areas of local resistance and failure. The study population are patients with high risk prostate malignancy treated with a combination of external beam radiation therapy (EBRT)/brachytherapy (BT) and androgen deprivation therapy (ADT). Patients enrolled in this trial will undergo a pre-treatment MRI and PSMA PET/CT prior to the initiation of ADT and the first EBRT fraction, a mid-treatment MRI and PSMA PET/CT prior to second brachytherapy fraction, and a third MRI and PSMA PET/CT will be performed after 75% testosterone recovery or 12 months post-ADT (whichever comes first). The pre-treatment MRI and PSMA PET/CT is part of standard of care for prostate cancer workup, however all additional MRI and PSMA PET/CT mid-treatment or after treatment completion are additional research scans.
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
- 未提供
排除标准
- •Eastern Cooperative Oncology Group (ECOG) performance status 3-5
- •Metastatic disease
- •Prior androgen deprivation therapy before study enrollment
- •Prior radiation to pelvis
- •Prior malignancy not achieving remission or with prognosis < 5 years
- •Synchronous malignancy confirmed or suspected
- •Any patient not suitable for brachytherapy
- •Severe claustrophobia precluding the acquisition of MRI
- •Unable to safely have 3T MRI
- •Cognitively impaired
研究组 & 干预措施
Treatment MRIs and Pylarify PSMA PET/CTs
2 MRIs and 2 Pylarify PSMA PET/CTs, occurring at mid-treatment and when testosterone level is 75% recovered or 12 months after androgen deprivation therapy (ADT), whichever comes first
干预措施: Pylarify Piflufolastat Flourine-18 (18F-DCFPyL) (Drug)
结局指标
主要结局
Difference from baseline (pre-treatment) to end of treatment scans for each patient in molecular/metabolic MRI to second brachytherapy treatment
时间窗: From start of treatment to 1 year after completion of treatment or recovery of 75% baseline testosterone after androgen depletion therapy.
Difference in the MRI imaging parameter Amide Proton Transfer (APT) weighted relative signal intensity between pretreatment scan and end-of-treatment scan in preselected regions of interest (ROIs) in both high-dose and low-dose regions will be analyzed in each image set per patient.
Difference from baseline (pre-treatment) to mid-treatment scans for each patient in PSMA PET/CT
时间窗: From start of treatment to before brachytherapy dose number 2, approximately day 15 of treatment
Difference in tumor voxel standard uptake value (SUV) between pretreatment scan and mid-treatment scan in preselected regions of interest (ROIs) in both high-dose and low-dose regions will be analyzed in each image set per patient.
Difference from baseline (pre-treatment) to end-of-treatment scans for each patient in PSMA PET/CT
时间窗: From start of treatment to 1 year after completion of treatment or recovery of 75% baseline testosterone after androgen depletion therapy.
Difference in tumor voxel standard uptake value (SUV) between pretreatment scan and end-of-treatment scan in preselected regions of interest (ROIs) in both high-dose and low-dose regions will be analyzed in each image set per patient.
Difference from baseline (pre-treatment) to mid-treatment scans for each patient in molecular/metabolic MRI to second brachytherapy treatment
时间窗: From start of treatment to before brachytherapy dose number 2, approximately day 15 of treatment
Difference in the MRI imaging parameter Amide Proton Transfer (APT) weighted relative signal intensity between pretreatment scan and mid-treatment scan in preselected regions of interest (ROIs) in both high-dose and low-dose regions will be analyzed in each image set per patient.
次要结局
未报告次要终点
研究者
Sirisha Nandalur, MD
Radiation Oncologist, Clinical Faculty
William Beaumont Hospitals