NCT06678126尚未招募2 期
Randomized Phase II 2 by 2 Factorial Trial of Adaptive Versus Non-adaptive Radiotherapy and 2 Bladder Filling Instructions for Patients with Intermediate or High Risk Localized Prostate Cancer (ARP)
Scott Tyldesley2 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2025年4月最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 104
- 试验地点
- 2
- 主要终点
- Assess the feasibility of randomization to adaptive vs standard radiotherapy localized high-risk prostate cancer.
研究概览
简要总结
The study is being done to compare the side effects between two different radiation techniques, standard non-adaptive radiation therapy vs. daily adaptive radiation therapy and also comparing two different bladder filling instructions to find out if customized bladder instructions may lead to better treatment outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 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
- •Pathological diagnosis of a primary prostate adenocarcinoma
- •NCCN Intermediate or high risk localized prostate cancer and clinically N0 and M0 by conventional imaging
- •Intermediate: one or more of cT2b-T2c, PSA 10-20, or Gleason Group 2 or 3
- •High: one or more of: cT3a, PSA > 20, or Gleason Group 4 or
- •Consented to RT with moderate hypofractionated RT to pelvic nodes (44 Gy) and prostate (60Gy) in 20 fractions using standard BC Cancer regimen
- •Able to complete BC Cancer POSI questionnairesWilling to attend adaptive treatment slot timing as required by treating centre.
- •Willing and able to have regular per protocol follow up and blood work
- •Feasible to start protocol treatment within 120 calendar days of participant enrolment
- •Continent of urine (or able to maintain continence with penile clamp/cuff during RT as needed) and able to follow bladder filling instructions.
- •Baseline IPSS score < 20 at time of enrolment.
- •ECOG performance Status : 0-
- •Nodal risk ≥ 20% using the Memorial Sloan Kettering Nodal Risk Nomogram (https://www.mskcc.org/nomograms/prostate/pre_op).
- •Negative for bone metastases on bone scan within 3 months of enrolment
- •No involved nodes on Abdomen and pelvic CT or pelvic MRI within 3 months of enrolment.
排除标准
- •Indwelling urinary catheter.
- •Hip prosthesis
- •Prior pelvic radiotherapy
- •Unable to lie still on RT treatment couch for more than 30 minutes
- •Clinical T3b or T4 tumours
- •Prior transurethral resection of prostate or radical prostatectomy
- •Presence of a pelvic kidney.
- •Prior pelvic radiotherapy.
- •Significant urinary incontinence: ie > 1 soaked, or 2 non-soaked pads per day.
- •Inflammatory bowel disease, systemic lupus erythematosis, scleroderma, or other connective tissue disorders other than rheumatoid arthritis.
- •Metastatic disease identified on staging investigations.
- •Any other serious intercurrent illness or medical condition judged by the local investigator to compromise the participant's safety, preclude safe administration of the planned protocol treatment, or prevent the participant from being managed according to the protocol guidelines
- •Potentially fertile patient who are unwilling to employ highly effective contraception
结局指标
主要结局
Assess the feasibility of randomization to adaptive vs standard radiotherapy localized high-risk prostate cancer.
时间窗: Accrual period, estimated 3.5 years
Accrual and randomization rate will be captured in REDCap database until the goal of 104 participants are randomized. With the accrual rate, we may imply it is feasible to do a larger more definitive and timely randomized control trial.
次要结局
- Measure and compare the patient reported Acute GU and GI bladder toxicity associated standard (SRT) and Adaptive (ART) radiotherapy for localized prostate cancer.(5 years after participant completes RT)
- Measure and compare the patient reported Late GU and GI bladder side effects associated standard (SRT) and Adaptive (ART) radiotherapy for localized prostate cancer.(5 years after participant completes RT)
- Measure and compare the physician reported CTCAE Acute (6 weeks post RT) GU and GI bladder CTCAE toxicity associated standard (SRT) and Adaptive (ART) radiotherapy for localized prostate cancer(5 years after participant completes RT)
- Determine which bladder filling instructions (BFI) are associated with daily shortest treatment time(approx 4 weeks during treatment of 20 fractions)
- Determine which BFIs are associated with least rescan and repeat CBCT requirements(approx 4 weeks during treatment of 20 fractions)
研究者
Scott Tyldesley
MD MPA ABR FRCPC
British Columbia Cancer Agency
研究点 (2)
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