ART of SABR: A Randomized Phase II Trial of Adaptive Radiation Therapy (ART) Stereotactic Ablative Body Radiotherapy (SABR) for Primary Localized Prostate Cancer: Two Versus Five Fractions
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 164
- 试验地点
- 10
- 主要终点
- Treatment-related, patient-reported early quality of life (QOL) changes
研究概览
简要总结
This clinical trial evaluates changes in quality of life after two treatments with near margin-less adaptive radiation therapy (ART) compared to five treatments with standard stereotactic ablative body radiotherapy (SABR) in patients with prostate cancer that has not spread to other parts of the body (localized). ART is a type of radiation therapy that uses information gathered during the treatment cycle to inform, guide, and alter future radiation treatments with respect to location and dose. It may be able to deliver radiation to the site of disease over a shorter time and with smaller margins (less treatment delivered to nearby healthy tissues). SABR is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). The total dose of radiation is divided into smaller doses given over several days. This type of radiation therapy helps spare normal tissue. Shorter duration near margin-less ART may be just as effective at treating patients with localized prostate cancer but have less quality of life side effects than standard SABR.
详细描述
PRIMARY OBJECTIVE:
I. To evaluate treatment-related, patient-reported early quality of life (QOL) changes between near "margin-less" ART in 2 fractions versus standard of care 3-5mm SABR in 5 fractions, using the Expanded Prostate Cancer Index Composite (EPIC)-26 bowel and urinary irritative/obstructive domains.
SECONDARY OBJECTIVES:
I. To assess treatment-related, patient-reported late QOL changes after SABR using the EPIC-26 bowel and urinary irritative/obstructive domains.
II. To assess and compare early physician-reported grade ≥ 2 gastrointestinal (GI) and/or genitourinary (GU) toxicities of interest within 3 months after SABR using Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Gender assigned male at birth: age ≥ 18 years
- •Histological confirmation of prostate adenocarcinoma
- •National Comprehensive Cancer Network (NCCN) (Prostate Cancer version 4.2022) low- to intermediate-risk prostate adenocarcinoma
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- •Ability to complete questionnaire(s) by themselves or with assistance
- •Signed informed consent
- •Willing to complete requirements for follow-up (during active monitoring phase)
排除标准
- •NCCN (Prostate Cancer version 4.2022) very low-, high-, or very high-risk prostate adenocarcinoma
- •Prior definitive treatment of prostate cancer including radiotherapy, prostatectomy, cryotherapy, or high intensity focused ultrasound (HIFU)
- •Prior bladder outlet obstruction procedures including transurethral resection of the prostate (TURP), Holmium laser enucleation of the prostate (HoLEP), transurethral vaporesection of the prostate (TUVRP), etc.
- •Metastatic disease by conventional or molecular imaging
- •Contraindications to radiation therapy (RT) including uncontrolled inflammatory bowel disease, ATM mutation, and Xeroderma pigmentosum mutation
- •Concurrent antineoplastic agents (chemotherapy)
- •Previous or concurrent malignancy other than non-melanoma skin cancer, indolent lymphoma, or chronic myelogenous leukemia, unless continuously disease-free ≥ 5 years
- •Medical or psychiatric conditions that preclude informed decision-making or adherence with the protocol-defined treatment or follow-up
- •Prostate gland volume > 80 cc based on magnetic resonance imaging (MRI), and/or International Prostate Symptom Score (IPSS) composite score > 17
- •Body weight > 200 kilogram
- •Known allergy or sensitivity to polyethylene glycol (PEG) or iodine
研究组 & 干预措施
Arm I (near margin-less ART)
Patients undergo near margin-less ART for 2 treatments at least 3 days apart in the absence of disease progression or unacceptable toxicity. Patients also undergo CBCT and may undergo CT and/or MRI on study.
干预措施: Computed Tomography (Procedure)
Arm I (near margin-less ART)
Patients undergo near margin-less ART for 2 treatments at least 3 days apart in the absence of disease progression or unacceptable toxicity. Patients also undergo CBCT and may undergo CT and/or MRI on study.
干预措施: Survey Administration (Other)
Arm I (near margin-less ART)
Patients undergo near margin-less ART for 2 treatments at least 3 days apart in the absence of disease progression or unacceptable toxicity. Patients also undergo CBCT and may undergo CT and/or MRI on study.
干预措施: Cone-Beam Computed Tomography (Procedure)
Arm I (near margin-less ART)
Patients undergo near margin-less ART for 2 treatments at least 3 days apart in the absence of disease progression or unacceptable toxicity. Patients also undergo CBCT and may undergo CT and/or MRI on study.
干预措施: Image-Guided Adaptive Radiation Therapy (Radiation)
Arm I (near margin-less ART)
Patients undergo near margin-less ART for 2 treatments at least 3 days apart in the absence of disease progression or unacceptable toxicity. Patients also undergo CBCT and may undergo CT and/or MRI on study.
干预措施: Magnetic Resonance Imaging (Procedure)
Arm II (standard SABR)
Patients undergo standard SABR for 5 treatments at least 2 days apart in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and/or MRI on study.
干预措施: Computed Tomography (Procedure)
Arm II (standard SABR)
Patients undergo standard SABR for 5 treatments at least 2 days apart in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and/or MRI on study.
干预措施: Magnetic Resonance Imaging (Procedure)
Arm II (standard SABR)
Patients undergo standard SABR for 5 treatments at least 2 days apart in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and/or MRI on study.
干预措施: Stereotactic Ablative Radiotherapy (Procedure)
Arm II (standard SABR)
Patients undergo standard SABR for 5 treatments at least 2 days apart in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and/or MRI on study.
干预措施: Survey Administration (Other)
结局指标
主要结局
Treatment-related, patient-reported early quality of life (QOL) changes
时间窗: Baseline; up to 3 months
Will be assessed using the Expanded Prostate Cancer Index Composite (EPIC)-26. The EPIC-26 consists of 13 questions answered on a variety of scales, such as 1-5 where 1=very poor and 5=very good.
次要结局
- Fiducial-free treatment(Up to 5 years)
- Local recurrence(Up to 5 years)
- Incidence of grade ≥ 2 genitourinary an/or gastrointestinal adverse events(Up to 24 months)
- Treatment-related, patient-reported late QOL changes(Baseline; up to 24 months)
- Bladder filling(Up to 5 years)
- Biochemical recurrence(At 2 and 5 years)
- Prostate specific antigen (PSA) kinetics(Up to 5 years)
- Change in International Index of Erectile Function (IIEF)(Baseline; up to 24 months)
- Change in International Prostate Symptom Score (IPSS)(Baseline; up to 24 months)
- Change in financial adverse events - COST-FACIT(Baseline; 12 months)
- Overall survival(From the date of registration to the date of death from any cause, assessed up to 5 years)