A Pilot Study of Dose dE-eScalaTion IN prostATe radIOtherapy usiNg the MRL
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Technical feasibility of treating prostate cancer with toxicity minimising radiotherapy on a MR-linac
研究概览
简要总结
Trial design: A single centre phase II non-randomised study
Trial population: Men with intermediate risk localised prostate cancer
Recruitment target: 20 patients in total
Trial objectives:
-
Primary To develop a 5 fraction de-escalated dose SBRT protocol capable of reducing side effects
-
Secondary
-
To assess levels of acute GU and GI toxicity (CTCAE)
-
To assess levels of late GU and GI toxicity (CTCAE)
-
To assess late sexual quality of life (expanded EPIC, IIEF-5)
-
To assess biochemical relapse-free survival at 2 years
Trial treatment: All radiotherapy will be delivered on the MR-linac. Intraprostatic dose will be varied according to risk of local recurrence, based on mpMRI, PSA and histology. The whole prostate will receive 30 Gy in 5 fractions and the GTV plus intra-prostatic margin will receive an isotoxic 45 Gy prescription.
详细描述
Primary endpoint: Technical feasibility of treating prostate cancer with toxicity- minimising radiotherapy on an MR-linac
Secondary endpoint:
- Physician reported GU and gastrointestinal (GI) toxicity (CTCAE grade) at baseline and the end of treatment then at 4 weeks and 3 months post-treatment.
- Late toxicity (CTCAE v5.0) at 1 and 2 years post-treatment
- Patient-reported outcome measures (PROMs) from the EPIC-26, IPSS, and IIEF-5 questionnaires. Patients will be asked to complete PROMs at 4 weeks, 3 and 6 months, 1 and 2 years post treatment.
- PSA control and kinetics at 2 years post-treatment
Quality of life: EPIC-26 QoL will be measured at baseline, then at 4 weeks and 3, 6, 12 and 24 months from end of treatment. IIEF-5 will be completed at baseline and months 6, 12 and 24. IPSS will be measured at all time points.
Follow-up: Patients will be assessed at 6, 12 and 24 months and then as per standard of care.
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
- •Men aged ≥18 years
- •Histological confirmation of prostate adenocarcinoma requiring radical radiotherapy
- •Gleason score 3+3, 3+4 or 4+3 (Grade groups 1, 2 or 3)
- •MRI stage T2 or less (as staged by AJCC TNM 2018)
- •MRI-visible tumour(s) of PIRADS v2 grade 3 or higher on T2 and diffusion-weighted imaging and/or dynamic contrast-enhanced imaging with concordant pathology
- •Dominant lesion <50% of prostate on any axial slice and <50% total prostate volume
- •PSA <20 ng/ml prior to starting ADT
- •Patients can be concurrently treated with androgen deprivation therapy if this would be standard of care. LHRH analogues or Bicalutamide are permitted. ADT is not mandatory where this would usually be omitted.
- •WHO Performance status 0-2
- •Ability of the participant understand and the willingness to sign a written informed consent form.
- •Ability/willingness to comply with the patient reported outcome questionnaires schedule throughout the study.
排除标准
- •Contraindications to MRI (e.g. pacemaker, potentially mobile metal implant, claustrophobia)
- •IPSS 19 or higher
- •High grade disease (GG3) occult to MRI-defined lesion
- •Post-void residual >100 mls, where known
- •Prostate volume >90cc
- •Comorbidities which predispose to significant toxicity (e.g. inflammatory bowel disease) or preclude long term follow up
- •Unilateral or bilateral total hip replacement, or other pelvic metalwork which causes artefact on diffusion-weighted imaging
- •Previous pelvic radiotherapy
- •Patients needing >6 months of ADT due to disease parameters.
- •Previous invasive malignancy within the last 2 years excluding basal or squamous cell carcinomas of the skin, low risk non-muscle invasive bladder cancer (assuming cystoscopic follow up now negative) or small renal masses on surveillance
研究组 & 干预措施
Experimental radiotherapy treatment
SBRT 5x30Gy of whole prostate and isotoxic 45 Gy GTV plus intra-prostatic margin
干预措施: De-escalated radiotherapy (Radiation)
结局指标
主要结局
Technical feasibility of treating prostate cancer with toxicity minimising radiotherapy on a MR-linac
时间窗: after 1,5 week of treatment
To establish the technical feasibility of treating prostate cancer with tumour-escalated/normal prostate de-escalated dose radiotherapy on an MR-linac. Feasiblity is defined as coverage of GTV boost D90% \>42Gy on the post-treatment imaging.
次要结局
- Acute GU toxicity(within 90 days after first radiation treatment)
- Late GU toxicity(After at least 90 days after the first radioation treatment up to 2 years)
- Late GI toxicity(After at least 90 days after the first radioation treatment up to 2 years)
- PROMs(2 years)
- Acute GI toxicity(within 90 days after first radiation treatment)
- Biochemical free survival(Up to 2 years)