Early Changes in Multiparametric MRI in Response to Neoadjuvant Androgen Deprivation and External Beam Radiation Therapy for Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 4
- 主要终点
- Correlation Between MRI Parameter at Visit 1 and Nadir PSA
研究概览
简要总结
In this research study, the investigators are trying to determine if there are measurable changes in prostate MRI that will help predict those who will or will not respond to Androgen Deprivation Therapy (ADT) and External Beam Radiation Therapy (EBRT) The first baseline prostate MRI prior to the start of treatment is standard of care. The participant's ADT/EBRT treatment is also standard of care, as advised by their doctor. It is the 3 follow up prostate MRIs during ADT/EBRT treatment, and 4 follow up serum PSA levels that are part of this research study.
详细描述
If the participant chooses to take part in this research study, the participant will have 3 follow up prostate MRIs during a 6 month time period, while the participant is having their ADT/EBRT treatment. These follow-up prostate MRIs will use a standard imaging protocol without the use of an endorectal coil. The participant will also have a total of 4 blood samples to measure serum PSA. 1-2 mls (just less than ½ teaspoon) will be taken for each sample.
Research Study Plan
- Baseline Visit (routine standard of care screening visit): PSA blood test and prostate MRI
- Visit 1 (8 weeks after starting ADT): PSA blood test and prostate MRI
- Visit 2 (6 weeks after starting EBRT): PSA blood test and prostate MRI
- Visit 3 (on last day of EBRT): PSA blood test
- Visit 4 (6 months after starting ADT): PSA blood test and prostate MRI
Planned Follow-up: The investigator would like to keep track of the participant's prostate cancer status while they continue to see their doctor at DFCI. The investigators would like to do this by collecting the following data from the participant's medical records, to look at long-term outcome of their ADT/EBRT treatment.
- PSA values
- Clinical results of your treatment. The investigator will not contact the participant to obtain this information.
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
- •Adult males with unfavorable intermediate- to high-risk localized disease, defined as having one of the following three categories, Clinical or radiographic T2b-T4 primary tumor or Gleason score 7-10 in any core, or PSA ≥ 10 prior to initiation of therapy
- •Patients are deemed suitable for therapy with ADT and EBRT.
- •Subjects must to able to provide informed written consent prior to study entry.
排除标准
- •The standard exclusion criteria for MRI exams will apply which include patients with pacemakers, non-compatible intra-cranial vascular clips, inner ear implants, and severe claustrophobia.
- •Patients who because of age, general medical or psychiatric condition, or physiologic status unrelated to the presence of prostate cancer are unlikely to be candidates for repeat MRIs, or cannot give valid informed consent.
- •Patients unwilling or unable to undergo the multiparametric MRI exam (non-endorectal coil).
- •Patients with a history of allergic reaction to latex or Gadolinium containing intravenous contrast agents.
- •Individuals with renal disease or other contraindications to gadolinium will be excluded. The BWH standard MRI contrast screening criteria will be used to establish renal status.
- •Patients who have had prior prostatectomy or prior androgen therapy.
- •Patients with hip implant or any other metallic implant or device that results in significant distortion of the local magnetic field and compromise of the quality of the multiparametric MRI data.
结局指标
主要结局
Correlation Between MRI Parameter at Visit 1 and Nadir PSA
时间窗: 2 months after starting ADT (Visit 1)
Pearson correlation coefficient between MRI parameters at visit 1 and nadir PSA
次要结局
- Correlation Between MRI Parameter at Visit 2 With Nadir PSA(6 weeks after starting EBRT (Visit 2))
研究者
Fiona Fennessy
Principal Investigator
Dana-Farber Cancer Institute