Germline DNA-Based Radiosensitivity Biomarker Influence on Toxicity Following Prostate Radiotherapy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 208
- 试验地点
- 1
- 主要终点
- 2-year cumulative incidence of late grade >= 2 physician-scored genitourinary toxicity
研究概览
简要总结
This trial studies the changes in long-term physician-scored genitourinary toxicity achieved in prostate cancer patients eligible for stereotactic radiation therapy when both patients and physicians have access to convincing but non-validated germline signature that can characterize patients as having a low or high risk of developing toxicity after radiation therapy. The information learned from this study may guide patients' and physicians' decisions on radiotherapy fractionation.
详细描述
PRIMARY OBJECTIVE:
I. To determine the impact on the 2-year cumulative incidence of late grade ≥2 genitourinary (GU) physician-scored toxicity, as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 scale, caused by presenting both the physicians and patients with the results of a non-prospectively validated biomarker panel that dichotomizes any given patient into having a high versus a low risk of late grade ≥2 GU physician-scored toxicity following stereotactic body radiotherapy (SBRT).
SECONDARY OBJECTIVES:
I. To determine the late grade ≥2 genitourinary (GU) physician-scored toxicity, as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 scale, in patients who test positive for the biomarker.
II. To determine the late grade ≥2 genitourinary (GU) physician-scored toxicity, as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 scale, in patients who test negative for the biomarker.
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
- •Histologically confirmed, clinical localized adenocarcinoma of the prostate
- •No evidence of disease beyond the prostate and/or seminal vesicles (i.e., no suspicious pelvic lymph nodes or presence of metastatic disease outside the pelvis)
- •Staging workup as recommended by the National Comprehensive Cancer Network (NCCN) on the basis of risk grouping:
- •Low risk: No staging workup required
- •Favorable intermediate-risk: computed tomography (CT) abdomen/pelvis only if Memorial Sloan Kettering Cancer Center (MSKCC) nomogram predicts > 10% probability of lymph node involvement (note: CT simulation scan will count as a CT abdomen/pelvis)
- •Unfavorable intermediate-risk: technetium bone scan, CT abdomen/pelvis if MSKCC nomogram predicts > 10% probability of lymph node involvement (note: CT simulation scan will count as a CT abdomen/pelvis)
- •High-risk: technetium bone scan, CT abdomen/pelvis if MSKCC nomogram predicts > 10% probability of lymph node involvement (note: CT simulation scan will count as a CT abdomen/pelvis) =
- •Advanced imaging studies (i.e. prostate specific membrane antigen [PSMA] positron emission tomography [PET] and Axumin scan) can supplant a bone scan if performed first
- •Ability to understand, and willingness to sign, the written informed consent
排除标准
- •Patients with neuroendocrine or small cell carcinoma of the prostate
- •Patients with any evidence of distant metastases. Note, evidence of lymphadenopathy below the level of the renal arteries can be deemed loco regional per the discretion of the investigator
- •Prior whole-gland cryosurgery, high-intensity focused ultrasound (HIFU) or brachytherapy of the prostate
- •Prior pelvic radiotherapy
- •History of Crohn's disease, ulcerative colitis, or ataxia telangiectasia
研究组 & 干预措施
Treatment (radiotherapy, genomic DNA testing)
Patients undergo SBRT per standard of care, then undergo collection of cheek swab and blood samples for the analysis of germline biomarkers. Afterwards, patients and their physicians engage in discussion about which form of radiotherapy to proceed with. Based on the decision, patients predicted to be at low risk of toxicity with SBRT continue to receive SBRT over 14 days while patients predicted to be at high risk of toxicity with SBRT will be counseled to undergo either conventionally fractionated radiotherapy over 63-70 days, moderate hypofractionated radiotherapy over 28-35 days, or may opt to still receive SBRT over 14 days per standard of care.
干预措施: Discussion (Procedure)
Treatment (radiotherapy, genomic DNA testing)
Patients undergo SBRT per standard of care, then undergo collection of cheek swab and blood samples for the analysis of germline biomarkers. Afterwards, patients and their physicians engage in discussion about which form of radiotherapy to proceed with. Based on the decision, patients predicted to be at low risk of toxicity with SBRT continue to receive SBRT over 14 days while patients predicted to be at high risk of toxicity with SBRT will be counseled to undergo either conventionally fractionated radiotherapy over 63-70 days, moderate hypofractionated radiotherapy over 28-35 days, or may opt to still receive SBRT over 14 days per standard of care.
干预措施: Hypofractionated Radiation Therapy (Radiation)
Treatment (radiotherapy, genomic DNA testing)
Patients undergo SBRT per standard of care, then undergo collection of cheek swab and blood samples for the analysis of germline biomarkers. Afterwards, patients and their physicians engage in discussion about which form of radiotherapy to proceed with. Based on the decision, patients predicted to be at low risk of toxicity with SBRT continue to receive SBRT over 14 days while patients predicted to be at high risk of toxicity with SBRT will be counseled to undergo either conventionally fractionated radiotherapy over 63-70 days, moderate hypofractionated radiotherapy over 28-35 days, or may opt to still receive SBRT over 14 days per standard of care.
干预措施: Laboratory Biomarker Analysis (Other)
Treatment (radiotherapy, genomic DNA testing)
Patients undergo SBRT per standard of care, then undergo collection of cheek swab and blood samples for the analysis of germline biomarkers. Afterwards, patients and their physicians engage in discussion about which form of radiotherapy to proceed with. Based on the decision, patients predicted to be at low risk of toxicity with SBRT continue to receive SBRT over 14 days while patients predicted to be at high risk of toxicity with SBRT will be counseled to undergo either conventionally fractionated radiotherapy over 63-70 days, moderate hypofractionated radiotherapy over 28-35 days, or may opt to still receive SBRT over 14 days per standard of care.
干预措施: Quality-of-Life Assessment (Other)
Treatment (radiotherapy, genomic DNA testing)
Patients undergo SBRT per standard of care, then undergo collection of cheek swab and blood samples for the analysis of germline biomarkers. Afterwards, patients and their physicians engage in discussion about which form of radiotherapy to proceed with. Based on the decision, patients predicted to be at low risk of toxicity with SBRT continue to receive SBRT over 14 days while patients predicted to be at high risk of toxicity with SBRT will be counseled to undergo either conventionally fractionated radiotherapy over 63-70 days, moderate hypofractionated radiotherapy over 28-35 days, or may opt to still receive SBRT over 14 days per standard of care.
干预措施: Questionnaire Administration (Other)
Treatment (radiotherapy, genomic DNA testing)
Patients undergo SBRT per standard of care, then undergo collection of cheek swab and blood samples for the analysis of germline biomarkers. Afterwards, patients and their physicians engage in discussion about which form of radiotherapy to proceed with. Based on the decision, patients predicted to be at low risk of toxicity with SBRT continue to receive SBRT over 14 days while patients predicted to be at high risk of toxicity with SBRT will be counseled to undergo either conventionally fractionated radiotherapy over 63-70 days, moderate hypofractionated radiotherapy over 28-35 days, or may opt to still receive SBRT over 14 days per standard of care.
干预措施: Stereotactic Body Radiation Therapy (Radiation)
结局指标
主要结局
2-year cumulative incidence of late grade >= 2 physician-scored genitourinary toxicity
时间窗: Up to 2 years
Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 scale, stratified by positive or negative status for the biomarker thought to predict for late grade \>= 2 genitourinary (GU) toxicity.
次要结局
- Change in patient-reported sexual quality of life by the Sexual Health Inventory for Men instrument by five years(Baseline up to 5 years)
- Change in patient-reported sexual quality of life outcome(Baseline up to 5 years)
- Change in patient-reported urinary quality of life(Baseline up to 5 years)
- Late grade ≥2 genitourinary (GU) physician-scored toxicity in patients who test positive for the biomarker(Up to 5 years)
- Late grade ≥2 genitourinary (GU) physician-scored toxicity in patients who test negative for the biomarker(Up to the first 90 days after radiotherapy)
- Proportions of patients who choose to receive conventionally fractionated radiotherapy, moderately hypofractionated radiotherapy, and SBRT, based on being positive or negative for the biomarker thought to predict for late grade ≥2 GU toxicity.(Up to the first 90 days after radiotherapy (acute).)
- 2- and 5-year cumulative incidences of late grade ≥2 GI physician-reported toxicity, based on being positive or negative for the biomarker thought to predict for late grade ≥2 GU toxicity.(Up to 5 years)
- Acute grade ≥2 GU and GI toxicity based on being positive or negative for the biomarker thought to predict for late grade ≥2 GU toxicity.(Up to 90 days)
- 5-year biochemical recurrence-free survival(Baseline up to 5 years)