SMART (Stereotactic MR-guided Adaptive Radiation Therapy) for Localized Prostate Cancer; a Phase II Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Early gastrointestinal toxicity
研究概览
简要总结
Rationale: This prospective study investigates the outcomes of daily online stereotactic MR-guided adaptive radiation therapy (SMART) in patients with localized prostate cancer (cT1c-T3bN0M0). Visualization of the prostate, rectum and bladder prior to and during radiation delivery can be used to deliver "gated" treatment (beam-on only when the prostate is in the predetermined position) using small uncertainty margins. The novel MRIdian treatment delivery system (ViewRay, USA), which will be used for this study, allows for the immediate generation of an optimal radiotherapy plan based on the current anatomy of the prostate and surrounding normal organs prior to each fraction. These major advances will (i.e. dosimetrically) allow for an optimisation of normal tissue radiation doses, which should theoretically decrease toxicity to surrounding organs such as the rectum or bladder. Another advantage of this approach is that online MR-based prostate imaging does not rely on implanted gold markers, avoiding an invasive procedure to insert such markers. If proven feasible, this approach could set a new standard of care for patients with localized prostate cancer.
The main goal of this phase II study of SMART for prostate cancer is to evaluate the early and early-delayed toxicity, i.e. within the first year after treatment. An established 5-fraction hypofractionated radiation scheme will be used in this trial.
Main outcome parameters will include gastro-intestinal, genitourinary and sexual symptoms, which will be monitored at fixed time points using CTCAE criteria. In addition, patient-reported outcomes will be evaluated using EORTC-QOL questionnaires.
Objective: To investigate the early and early-delayed toxicity profile of SMART in patients with localized prostate cancer.
Study design:phase II observational study Study population: 100 consecutive patients with localized prostate cancer (cT1c-T3bN0M0).
Study intervention: Study patients will be treated with an online MR-guided hypofractionated course of radiotherapy in 5 fractions of 7.25 Gy per fraction delivered on the prostate with a simultaneous integrated sparing of the urethra with a dose of 32.5 Gy in 5 fractions Main study parameters: Early and early-delayed toxicity (CTCAE v. 4.0); (IPSS) and Qol C30 PR25. Secondary endpoint will be the offline evaluation of the dosimetric benefit of SMART by comparing cumulative doses to organs at risk.
详细描述
Rationale: This prospective study investigates the outcomes of daily online stereotactic MR-guided adaptive radiation therapy (SMART) in patients with localized prostate cancer (cT1c-T3bN0M0). Visualization of the prostate, rectum and bladder prior to and during radiation delivery can be used to deliver "gated" treatment (beam-on only when the prostate is in the predetermined position) using small uncertainty margins. The novel MRIdian treatment delivery system (ViewRay, USA), which will be used for this study, allows for the immediate generation of an optimal radiotherapy plan based on the current anatomy of the prostate and surrounding normal organs prior to each fraction. These major advances will (i.e. dosimetrically) allow for an optimisation of normal tissue radiation doses, which should theoretically decrease toxicity to surrounding organs such as the rectum or bladder. Another advantage of this approach is that online MR-based prostate imaging does not rely on implanted gold markers, avoiding an invasive procedure to insert such markers. If proven feasible, this approach could set a new standard of care for patients with localized prostate cancer.
The main goal of this phase II study of SMART for prostate cancer is to evaluate the early and early-delayed toxicity, i.e. within the first year after treatment. An established 5-fraction hypofractionated radiation scheme will be used in this trial. At VUmc, experience with this scheme has been obtained as a result of participation in a recently concluded multicenter randomized phase II trial [METc NL4181402912; 20012/398]. Main outcome parameters will include gastro-intestinal- (GI), genitourinary- (GU) and sexual symptoms, which will be monitored at fixed time points using CTCAE criteria. In addition, patient-reported outcomes will be evaluated using EORTC-QOL questionnaires.
Objective: To investigate the early and early-delayed toxicity profile of SMART in patients with localized prostate cancer.
Study design: A phase II observational study Study population: 100 consecutive patients with localized prostate cancer (cT1c-T3bN0M0).
Study intervention: Study patients will be treated with an online MR-guided hypofractionated course of radiotherapy in 5 fractions of 7.25 Gy per fraction delivered on the prostate with a simultaneous integrated sparing (SIS) of the urethra with a dose of 32.5 Gy in 5 fractions (6.5 Gy per fraction). This stereotactic radiation scheme was also used in [METc NL4181402912; 20012/398].
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age of 18 years or older
- •WHO performance score 0-2
- •Biopsy proven adenocarcinoma of the prostate
- •Gleason ≥ 6
- •Prostate volume ≤ 90 cc on TRUS
- •T-stage: cT1c-T3b (on MRI and/or endorectal ultrasound)
- •All patients should be able to undergo MRI scans
- •No evidence of lymph node or distant metastases on radiological staging
- •The multidisciplinary team advised external beam radiotherapy treatment
- •IPSS (International Prostate Symptoms Score) ≤19
- •Previous TURP is allowed provided there is at least 8 weeks interval with radiotherapy
- •The administration of concomitant hormonal therapy is allowed
- •Ability to provide written informed consent.
排除标准
- •Previous irradiation in the pelvic region
- •Contra-indications for MRI
- •As no safety data for 0.35 Tesla MRI scanners are available on electronic devices such as pacemakers or implanted defibrillators, deep brain stimulators, cochlear implants, this constitutes an absolute contraindication for this study, even for devices that have been considered safe for MRI scans with higher magnetic field strengths.
- •Patients who have a metallic foreign body in their eye, or who have an aneurysm clip in their brain, cannot have an MRI scan since the magnetic field may dislodge the metal
- •Patients with severe claustrophobia may not be able to tolerate an MRI scan
- •Patients with a hip prosthesis will not be eligible for the MRI scan
结局指标
主要结局
Early gastrointestinal toxicity
时间窗: determined at 3 months
Common Terminology Criteria for Adverse Events (CTCAE v4.0)
Late gastrointestinal toxicity
时间窗: determined at 12 months
Common Terminology Criteria for Adverse Events (CTCAE v4.0)
Early genitourinary toxicity
时间窗: determined at 3 months
Common Terminology Criteria for Adverse Events (CTCAE v4.0)
Late genitourinary toxicity
时间窗: determined at 12 months
Common Terminology Criteria for Adverse Events (CTCAE v4.0)
Early prostate specific quality of life (QoL)
时间窗: determined at 3 months
EORTC QLQ-PR25
Late quality of life (QoL)
时间窗: determined at 12 months
EORTC QoL core questionnaire (QLQ-C30)
Early quality of life (QoL)
时间窗: determined at 3 months
EORTC QoL core questionnaire (QLQ-C30)
Late prostate specific quality of life (QoL)
时间窗: determined at 12 months
EORTC QLQ-PR25
次要结局
未报告次要终点
研究者
Anna Bruynzeel
Principal Investigator
Amsterdam UMC, location VUmc