INSPIRE: INnovative SABR for Prostate Cancer All IREland
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 136
- 试验地点
- 4
- 主要终点
- Late GU toxicity
研究概览
简要总结
This is a Phase II, single arm, multi-centre, prospective clinical trial evaluating next generation Stereotactic Ablative Radiotherapy (SABR) for low, intermediate, and eligible high-risk prostate cancer. Eligible patients will receive next generation prostate SABR incorporating toxicity reduction strategies
详细描述
This is a Phase II, single arm, multi-centre, prospective clinical trial evaluating next generation Stereotactic Ablative Radiotherapy (SABR) for low, intermediate, and eligible high-risk prostate cancer. Eligible patients will receive next generation prostate SABR incorporating toxicity reduction strategies: urethral/trigone sparing, rectal hydrogel spacer, and neurovascular bundle preservation [as per Desai POTEN-C trial, Desai et al., 2025].
Treatment will prioritise the dominant intraprostatic lesion (DIL) while sparing surrounding organs at risk (OARs). Planned doses are: DIL 40-50 Gy in 5 fractions delivered on alternate days, prostate CTV 35 Gy, PTV 33.25 Gy, and urethral PRV 32.5 Gy. Eligible high-risk and some intermediate-risk patients may receive 6-12 months of androgen deprivation therapy (ADT)/hormonal therapy at the physician's discretion, provided they have not received >14 weeks prior to registration.
Radiotherapy planning will include advanced image-guided verification with fiducial markers, pre-treatment dosimetry to minimise dose to OARs, and adherence to protocol-defined constraints for urethra, rectum, and neurovascular bundles. Peri-rectal spacers will be inserted 7-10 days prior to CT-simulation to reduce rectal dose. Dose prioritisation allows full coverage of the DIL while sparing urethra, bladder trigone, and neurovascular bundles to minimise genitourinary, rectal, and sexual toxicity.
Follow-up assessments will include clinical evaluation, toxicity reporting using v5 NCI CTCAE, and patient-reported outcome measures (PRO/QoL) at 2-, 4-, 8-, and 12-weeks post-treatment, 6 and 9 months, and annually up to 5 years. Data on biochemical/clinical failure, progression-free survival, and initiation or re-initiation of ADT will also be collected.
A total of 136 patients will be enrolled to achieve 122 evaluable participants, allowing detection of a statistically significant reduction in Grade ≥2 late genitourinary toxicity compared to historical SABR controls.
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
- •Written informed consent obtained prior to any study-related procedures
- •Males ≥ 18 years of age
- •ECOG performance status (PS) 0-2
- •Biopsy-proven prostate adenocarcinoma without neuro-endocrine differentiation (within 18 months prior to registration, unless on active surveillance and re-biopsy not clinically indicated)
- •Gleason score ≤ 4+3
- •Clinical and/or MRI stage T1c-T3a, N0-X, M0-X
- •PSA ≤ 30 ng/ml (within 60 days prior to registration / prior to starting androgen-deprivation therapy (ADT/hormone therapy) [PSA ≤ 15 ng/ml for patients on 5-alpha reductase inhibitors]
- •Patients belonging to one of the following risk groups:
- •Low risk - patients meeting all of the following criteria:
- •Gleason ≤ 6
- •Clinical stage T1c-T2a
- •PSA < 10 ng/ml (within 60 days prior to registration)
- •Intermediate risk - patients meeting any of the following criteria, assuming no high-risk features apply:
- •Gleason 7 (3+4 or 4+3)
- •MRI stage T2b-T2c (N0, M0-X)
- •PSA 10-20 ng/ml (within 60 days prior to registration)
- •High risk - patients with tumours that meet a maximum of one of the following criteria:
- •MRI stage T3a (N0, M0)
- •PSA >20 - ≤30 ng/ml (within 60 days prior to registration)
排除标准
- •Previous malignancy within the last 2 years (except basal cell carcinoma (BCC) or squamous carcinoma of the skin), or if previous malignancy is expected to significantly compromise 5 year survival
- •Prior pelvic radiotherapy
- •Any prior active treatment for prostate cancer (with the exception of ADT). Patients previously on active surveillance are eligible if they continue to meet all other eligibility criteria.
- •Life expectancy <5 years.
- •Bilateral hip prostheses or any other implants/hardware that would introduce substantial CT artefacts
- •Medical conditions likely to make radiotherapy inadvisable e.g. inflammatory bowel disease, significant urinary symptoms.
- •Anticoagulation with warfarin/bleeding tendency making fiducial placement or surgery unsafe in the opinion of the clinician. Note: Anti-platelet agents e.g. aspirin, clopidogrel and DOACs such as apixaban, rivaroxaban are not contraindications to trial entry.
- •Participation in another concurrent treatment protocol for prostate cancer (not including QoL, survivorship, exercise or registry studies).
研究组 & 干预措施
Next generation Stereotactic Ablative Radiotherapy (SABR)
Eligible patients will receive next generation prostate SABR incorporating toxicity reduction strategies: urethral/trigone sparing, rectal hydrogel spacer, and neurovascular bundle preservation.
干预措施: Next generation Stereotactic Ablative Radiotherapy (SABR) (Radiation)
结局指标
主要结局
Late GU toxicity
时间窗: 2 years after last fraction
Rate of ≥ Grade 2 version 5 (v5) NCI CTCAE late GU toxicity in next-generation prostate SABR at 2 years.
次要结局
- Acute GU Toxicity(≤12 weeks after last fraction)
- Acute GI Toxicity(≤12 weeks after last fraction)
- Late GU toxicity at 5 years(5 years after last fraction)
- Late GI toxicity at 5 years(5 years after last fraction)
- Patient-Reported Outcomes (PRO) / Quality of Life (QoL) assessments for all patients via Expanded Prostate Cancer Index Composite Short Form (EPIC-26).(4 weeks, 12 weeks, 6, 9, and 12 months, 24 months, 36 months, 48 months, 60 months after treatment)
- Patient-Reported Outcomes (PRO) / Quality of Life (QoL) assessments for all patients via International Index of Erectile Function (IIEF-5).(12 weeks, 6 and 12 months, 24 months, 36 months, 48 months, 60 months after treatment)
- Patient-Reported Outcomes (PRO) / Quality of Life (QoL) assessments for all patients via International Prostate Symptom Score (IPSS).(4 weeks, 12 weeks, 6, 9, and 12 months, 24 months, 36 months, 48 months, 60 months after treatment)
- Freedom from biochemical or clinical failure.(The primary timepoint of interest is 5 years from registration.)
- Disease specific survival and overall survival(5 years from registration.)
- Progression-free survival (PFS)(5 years from registration)
- To assess commencement or re-commencement of androgen deprivation therapy (ADT)(Up to five years post last fraction.)