Dose dE-eScalaTion IN prostATe radIOtherapy usiNg an MR-Linac in 2 Fractions - a Randomised Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Acute GU toxicity
研究概览
简要总结
DESTINATION 2 is a multi-centre randomised trial treating intermediate risk localised prostate cancer with 2 fraction Stereotactic Body Radiotherapy (SBRT). All radiotherapy will be delivered in two fractions (sessions) on an MR Linac using daily adaptation. Men will either receive uniform dose radiotherapy or de-escalated dose radiotherapy. The primary endpoint is acute GU CTCAE v5 grade 2+ toxicity. It will also look at late toxicity, patient-reported outcome measures and PSA control.
详细描述
24 patients meeting inclusion criteria will be randomised between two arms. Arm 1 (Uniform dose) will receive 27 Gy in 2 fractions to the whole prostate + seminal vesicles (SV), the CTV, with 0 mm CTV-PTV margin. Arm 2 (De-escalated dose) will use two dose levels: The benign prostate (on MRI) will receive 20 Gy in 2 fractions with a 0mm PTV margin. The intraprostatic tumour mass(es) as seen on MRI will receive 27 Gy in 2 fractions. A 4mm GTV-PTV margin will be added to the MR visible tumour to form PTV 27Gy. The primary endpoint is emergent acute GU CTCAE v5 Grade 2+ toxicity, recorded within 3 months of completing radiotherapy. Secondary endpoints are CT CAE v5 acute GI toxicity, late toxicity, patient-reported outcome measures (PROMs) (EPIC-26, IPSS, and IIEF-5) at 4 and 12 weeks, 6 months, 1 and 2 years post treatment, PSA control and kinetics
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
- •Men aged ≥18 years
- •Histological confirmation of prostate adenocarcinoma requiring radical radiotherapy
- •Gleason score 3+3, 3+4 or 4+3 (Grade groups (GG) 1, 2 or 3)
- •MRI stage T3a or less (as staged by AJCC TNM 2018). MRI must be performed within a year of randomisation
- •MRI-visible tumour(s) of PIRADS v2 grade 3 or higher and able to be delineated on T2 and diffusion-weighted imaging +/- dynamic contrast-enhanced imaging. Tumour nodule visible on MRI should be considered able to be boosted by treating clinician and <2.5cm in maximal dimension
- •The MRI-defined lesion must be confirmed as malignant on biopsies (Gleason grade must be within the limits expressed in inclusion factor 3)
- •Short course (< 6 months) concurrent androgen deprivation therapy (antiandrogens or LHRH analogues) allowed though not mandated as per the discretion of the treating physician.
- •PSA <20 ng/ml prior to starting ADT, if used
- •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 Score > 19
- •High grade disease (GG3) occult to MRI-defined lesion.
- •Prostate volume >90cc
- •Comorbidities which predispose to significant toxicity (e.g. inflammatory bowel disease) or preclude long term follow up
- •Hip replacement, or other pelvic metalwork which causes significant artefact on diffusion-weighted imaging
- •Previous pelvic radiotherapy
- •Patients needing >6 months of ADT due to disease parameters, as per the discretion of the treating physician
- •Previous invasive malignancy within the last 2 years where this is likely to shorten lifespan the following will remain eligible: basal or squamous 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
Uniform dose
Arm 1 (Uniform dose) will receive 27 Gy in 2 fractions to the whole prostate + seminal vesicles (SV), the CTV, with 0 mm CTV-PTV margin.
干预措施: Prostate radical radiotherapy (Radiation)
De-escalated dose
Arm 2 (De-escalated dose) will use two dose levels:
The benign prostate (on MRI) will receive 20 Gy in 2 fractions with a 0mm PTV margin.
The intraprostatic tumour mass(es) as seen on MRI will receive 27 Gy in 2 fractions. A 4mm GTV-PTV margin will be added to the MR visible tumour to form PTV 27Gy.
干预措施: Prostate radical radiotherapy (Radiation)
结局指标
主要结局
Acute GU toxicity
时间窗: 12 weeks
To describe the absolute risk and relative risk reduction of acute genitourinary (GU) toxicity (CTCAE v5) when delivering de-escalated two fraction prostate SBRT compared to uniform dose two fraction prostate stereotactic body radiotherapy (SBRT) for intermediate risk prostate cancer.
次要结局
- Acute Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0) toxicity(Baseline, at completion of radiotherapy, Week 2, Week 4, and Week 12)
- Late Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0) toxicity(Month 6, 12, 24)
- Feasibility of radiation delivery(During each treatment fraction)
- Dosimetry(During each treatment fraction)
- Patient reported outcome measures(Baseline, at completion of radiotherapy, Week 2, Week 4, Week 12, 6 months, 1 year, and 2 years after treatment completion)
- Patient reported outcome measures(Baseline, 4 and 12 weeks, 6 months, 1 and 2 years post treatment.)
- Patient reported outcome measures(Baseline, 6 months, 1 and 2 years post treatment.)
- PSA kinetics(Baseline (prior to starting ADT), Week 12, Month 6, Year 1, and Year 2 after treatment completion)