NCT01411332已完成不适用
A Phase III Trial of Hypofractionated External Beam Image-Guided Highly Targeted Radiotherapy: The HEIGHT Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Number of Participants With Biopsy Failure
研究概览
简要总结
- Delivery of directed hypofractionated targeted (HT) radiotherapy (RT) tumor boost to the dominant tumor lesion in the prostate as identified by multiparametric MRI will increase tumor eradication from the prostate.
- Biomarker expression levels differ in the multiparametric MRI defined regions at high risk of harboring tumors that determine outcome.
- 10-15% of men undergoing RT have Circulating DNA or tumor cells (CTC) that are related to an adverse treatment outcome.
- Quality of life will not differ significantly between the treatment arms.
- Prostate cancer-related anxiety will be reduced in the HTIMRT arm, because the patients will be aware that the dominant tumor will be targeted with higher radiation dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 85 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •A. Biopsy confirmed adenocarcinoma of the prostate.
- •B. T1-T3a disease based on digital rectal exam.
- •T1a is permitted if peripheral zone biopsies are positive.
- •T3a disease based on MRI is acceptable.
- •C. No evidence of metastasis by any clinical criteria or available radiographic tests.
- •D. Gleason score 6-
- •E. Patients with Gleason score 8 must be offered long term androgen deprivation therapy (ADT) and refuse such treatment because only 4-6 (±2 months) months (short term ADT) is permitted on this protocol. Gleason score ≥ 8 patients should be recommended to receive short term ADT in conjunction with RT. When given, the ADT recommended to begin after fiducial marker placement, if applicable; however, ADT is permitted to have been started up to two months prior to the signing of consent.
- •Patients with Gleason score 8 disease must have <40 of the diagnostic tumor tissue involved with tumor.
- •Patients with Gleason score ≤7 may be treated with 4-6 (±2 months) months of ADT.
- •F. PSA ≤100 ng/mL within 3 months of enrollment. If PSA was above 100 and dropped to ≤100 with antibiotics, this is acceptable for enrollment.
- •G. If PSA is >15 ng/ml or there is ≥ Gleason 8 disease, a bone scan should be obtained ≤4 months before enrollment and should be without evidence of metastasis. A questionable bone scan is acceptable if plain x-rays, CT and/or MRI are negative for metastasis.
- •H. No previous pelvic radiotherapy
- •I. No previous history of radical/total prostatectomy (suprapubic prostatectomy is acceptable)
- •J. No concurrent, active malignancy, other than nonmetastatic skin cancer or early stage chronic lymphocytic leukemia (well-differentiated small cell lymphocytic lymphoma). If a prior malignancy is in remission for ≥ 5 years then the patient is eligible.
- •K. Identifiable multiparameter functional MRI defined tumor lesion or lesions using a 1.5T or 3.0T MRI (3.0T preferable), that total in volume <33% of the prostate within 3 months prior to enrollment.
- •a. Multiparametric functional including diffusion weighted imaging (DWI) of prostate and pelvis is required prior to protocol consideration
- •L. Ability to understand and the willingness to sign a written informed consent document
- •M. Zubrod performance status <2 (Karnofsky or Eastern Cooperative Oncology Group (ECOG) performance status may be used to estimate Zubrod)
- •N. Willingness to fill out quality of life/psychosocial forms.
- •O. Age ≥35 and ≤85 years.
- •P. Serum testosterone is within 40% of normal assay limits (e.g., x=0.4*lower assay limit and x=.04*upper assay limit + upper assay limit),, taken within 4 months of enrollment. Patients who have been started on ADT prior to signing consent are not required to have a serum testosterone at this level prior to signing consent; but, a serum testosterone prior to fiducial marker placement is recommended.
- •Q. Serum liver function tests (LFTs) taken within 3 months of enrollment.
- •R. Complete blood counts taken within 3 months of enrollment.
- •Exclusion Criteria
- •A. Previous pelvic radiotherapy.
- •B. Previous history of radical prostatectomy.
- •C. Concurrent, active malignancy, which is not nonmetastatic skin cancer or early stage chronic lymphocytic leukemia (well-differentiated small cell lymphocytic lymphoma). If a prior malignancy is in remission for < 5 years then the patient is not eligible
- •D. Not willing to fill out quality of life/psychosocial questionnaires.
排除标准
- 未提供
结局指标
主要结局
Number of Participants With Biopsy Failure
时间窗: Up to 2.25 years
Number of participants showing positive prostate biopsy finding post treatment.
次要结局
- Toxicity Rate(Up to 6 years)
- Mortality(Up to 6 years)
- Failure Rate(Up to 6 years)
- EPIC SF-12 Scores(At baseline, at last week of treatment (Up to 8 weeks), at 6 weeks after treatment (Up to 14 weeks), at 3 months after treatment (Up to 20 weeks), at 9 months after treatment (Up to 44 weeks).)
- MAX-PC Scores(At baseline, at last week of treatment (Up to 8 weeks), at 6 weeks after treatment (Up to 14 weeks), at 3 months after treatment (Up to 20 weeks), at 9 months after treatment (Up to 44 weeks))
- Biomarker Expression in Prostate Tumor Regions(Up to 3 years)
- Incidence of Circulating Free DNA(Up to 3 years)
研究者
Alan Pollack, MD, PhD
Professor
University of Miami
研究点 (2)
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