MRI- or CT-Guidance and Online Adaptation With Stereotactic Radiotherapy for Prostate Cancer (MANTICORE)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 186
- 试验地点
- 1
- 主要终点
- Acute clinically relevant decline in the urinary irritative/obstructive subdomain of the Expanded Prostate Cancer Index Composite Short Form Questionnaire (EPIC-26)
研究概览
简要总结
This clinical trial studies the side effects of image-guidance and online adaptation with stereotactic body radiation therapy (SBRT) for the treatment of patients with prostate adenocarcinoma that has not spread to other parts of the body (localized). Image-guided SBRT is a standard treatment for localized prostate cancer. This treatment uses imaging of the cancer within the body to define and localize the area to be treated with the radiation. Imaging can be obtained using either computed tomography (CT), magnetic resonance imaging (MRI), or a combination of the two. Typically, with SBRT, a radiation plan is developed based on the CT or MRI images obtained before treatment begins and adjustments are not made to the plan during treatment. However, anatomy can be different from day-to-day which may cause radiation to be delivered to the normal surrounding structures and possibly more side effects. During image-guided SBRT with online adaptation, the initial radiation plan is designed similarly; however, when the patient presents for radiation, the attending radiation oncologist, a dosimetrist, and a medical physicist "re-optimize" the radiation plan using the current anatomy of the day, meaning the changes in bladder and prostate size/shape are taken into account. The initial plan and the re-optimized plan are then compared, and the plan that has the optimal balance between delivering a tumor killing dose of radiation and minimizing radiation dose to normal surrounding structures is delivered. Image-guidance and online adaptation with SBRT may lower side effects and be a safer way to treat localized prostate adenocarcinoma.
详细描述
PRIMARY OBJECTIVE:
I. To determine whether daily, real-time adaptive SBRT to the prostate improves acute patient-reported genitourinary (GU) toxicity when compared with conventional, non-adaptive SBRT to the prostate for localized prostate cancer.
SECONDARY OBJECTIVES:
I. To determine whether there are differences in the acute, patient-reported other toxicity following daily, real-time adaptive versus conventional, non-adaptive SBRT for localized prostate cancer.
II. To determine whether there are chronic differences in patient-reported quality of life (QOL) outcomes following daily, real-time adaptive versus conventional, non-adaptive SBRT for localized prostate cancer.
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
- Single (Investigator)
盲法说明
This block size will be blinded to the radiation oncology research team when enrolling a patient. The arm allocation will be masked until after the screening/baseline data are entered and filled out in Research Electronic Data Capture (REDCap) (no anticipation of the group assignment will be possible).
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, clinically localized adenocarcinoma of the prostate
- •Staging workup as recommended by the National Comprehensive Cancer Network (NCCN) on the basis of risk grouping
- •Advanced imaging studies (i.e. prostate-specific membrane antigen [PSMA] positron emission tomography [PET]/CT and fluciclovine PET/CT scan) can supplant a bone scan if performed first
- •No evidence of metastatic disease in lymph nodes above the bifurcation of the renal arteries, or in bones or visceral organs (nodal disease identified on a PSMA PET/CT scan below the bifurcation of the renal arteries are amenable)
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- •No indication for urgent or emergent radiation
- •Written informed consent obtained from participant or participant's legal representative and ability for participant to comply with the requirements of the study
排除标准
- •Patients with neuroendocrine or small cell carcinoma of the prostate
- •Patients with any evidence of distant metastases except that evidence of lymphadenopathy below the level of the renal arteries can be deemed locoregional per the discretion of the investigator
- •Prior cryosurgery, high-intensity focused ultrasound (HIFU), brachytherapy, or other ablative treatments of the whole prostate
- •Prior pelvic radiotherapy
- •History of Crohn's disease, ulcerative colitis, or ataxia telangiectasia
- •Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the participant or the quality of the data
研究组 & 干预措施
Arm 1 (non-adaptive SBRT)
Patients undergo MRI or CT-guided SBRT without daily plan adaptation once every other day or QD for a total of 5 treatments over 18 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo MRI and CT during screening and blood sample collection throughout the trial.
干预措施: Biospecimen Collection (Procedure)
Arm 1 (non-adaptive SBRT)
Patients undergo MRI or CT-guided SBRT without daily plan adaptation once every other day or QD for a total of 5 treatments over 18 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo MRI and CT during screening and blood sample collection throughout the trial.
干预措施: Computed Tomography (Procedure)
Arm 1 (non-adaptive SBRT)
Patients undergo MRI or CT-guided SBRT without daily plan adaptation once every other day or QD for a total of 5 treatments over 18 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo MRI and CT during screening and blood sample collection throughout the trial.
干预措施: CT-guided Stereotactic Body Radiation Therapy (Radiation)
Arm 1 (non-adaptive SBRT)
Patients undergo MRI or CT-guided SBRT without daily plan adaptation once every other day or QD for a total of 5 treatments over 18 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo MRI and CT during screening and blood sample collection throughout the trial.
干预措施: Magnetic Resonance Imaging (Procedure)
Arm 1 (non-adaptive SBRT)
Patients undergo MRI or CT-guided SBRT without daily plan adaptation once every other day or QD for a total of 5 treatments over 18 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo MRI and CT during screening and blood sample collection throughout the trial.
干预措施: MRI-guided Stereotactic Body Radiation Therapy (Radiation)
Arm 1 (non-adaptive SBRT)
Patients undergo MRI or CT-guided SBRT without daily plan adaptation once every other day or QD for a total of 5 treatments over 18 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo MRI and CT during screening and blood sample collection throughout the trial.
干预措施: Survey Administration (Other)
Arm 2 (adaptive SBRT)
Patients undergo MRI or CT-guided SBRT with daily plan adaptation once every other day or QD for a total of 5 treatments over 18 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo MRI and CT during screening and blood sample collection throughout the trial.
干预措施: Biospecimen Collection (Procedure)
Arm 2 (adaptive SBRT)
Patients undergo MRI or CT-guided SBRT with daily plan adaptation once every other day or QD for a total of 5 treatments over 18 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo MRI and CT during screening and blood sample collection throughout the trial.
干预措施: Computed Tomography (Procedure)
Arm 2 (adaptive SBRT)
Patients undergo MRI or CT-guided SBRT with daily plan adaptation once every other day or QD for a total of 5 treatments over 18 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo MRI and CT during screening and blood sample collection throughout the trial.
干预措施: CT-guided Stereotactic Body Radiation Therapy (Radiation)
Arm 2 (adaptive SBRT)
Patients undergo MRI or CT-guided SBRT with daily plan adaptation once every other day or QD for a total of 5 treatments over 18 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo MRI and CT during screening and blood sample collection throughout the trial.
干预措施: Inter-fraction Adaptation of Treatment Plan (Other)
Arm 2 (adaptive SBRT)
Patients undergo MRI or CT-guided SBRT with daily plan adaptation once every other day or QD for a total of 5 treatments over 18 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo MRI and CT during screening and blood sample collection throughout the trial.
干预措施: Magnetic Resonance Imaging (Procedure)
Arm 2 (adaptive SBRT)
Patients undergo MRI or CT-guided SBRT with daily plan adaptation once every other day or QD for a total of 5 treatments over 18 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo MRI and CT during screening and blood sample collection throughout the trial.
干预措施: MRI-guided Stereotactic Body Radiation Therapy (Radiation)
Arm 2 (adaptive SBRT)
Patients undergo MRI or CT-guided SBRT with daily plan adaptation once every other day or QD for a total of 5 treatments over 18 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo MRI and CT during screening and blood sample collection throughout the trial.
干预措施: Survey Administration (Other)
结局指标
主要结局
Acute clinically relevant decline in the urinary irritative/obstructive subdomain of the Expanded Prostate Cancer Index Composite Short Form Questionnaire (EPIC-26)
时间窗: From start of stereotactic body radiation therapy (SBRT) to 90 days following SBRT
A clinically relevant decrement in the EPIC-26 urinary irritative/obstructive domain is defined as greater than 14 points. Will compare the proportion of patients with a clinically relevant in genitourinary EPIC-26 urinary irritative/obstructive subdomain within 90 days of study therapy via a simple binomial test for differences in proportions. A more granular analysis will be based on the cumulative incidence method will be used to summarize risk of clinically relevant decline and Fine-Gray test will be used to compare cumulative incidences between the two arms. The analysis population includes all randomized subjects based on intent-to-treat principle. Point estimates as well as the associated 95% confidence intervals will be reported. Will also be evaluated using a multivariable analysis adjusted for variables including a simultaneous integrated boost, use of nodal radiotherapy, and use of hydrogel spacers.
次要结局
- Acute change in EPIC-26 scores(From start of SBRT to 90 days following SBRT)
- Acute change in International Prostate Symptom Score (IPSS)(From start of SBRT to 90 days following SBRT)
- Acute change in Sexual Health Inventory for Men (SHIM) scores(From start of SBRT to 90 days following SBRT)
- Chronic change in IPSS(From start of SBRT to 60 months following SBRT)
- Chronic change in EPIC-26 scores(From start of SBRT to 60 months following SBRT)
- Chronic change in SHIM scores(From start of SBRT to 60 months following SBRT)
- Incidence of physician-scored acute grade ≥ 2 genitourinary (GU) and gastrointestinal (GI) toxicities(From start of SBRT to 90 days following SBRT)
- Incidence of physician-score late grade ≥ 2 GU and GI toxicities(From start of SBRT to 60 months following SBRT)
- Biochemical recurrence-free survival(Up to 60 months)