Treatment Expedition With MRI Processing and Optimization for Muscle Invasive Bladder Cancer
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 92
- 试验地点
- 2
- 主要终点
- Time to definitive treatment
研究概览
简要总结
The TEMPO-MIBC trial is a phase III, single-center, two-arm, randomized, controlled trial. Its primary objective is to evaluate the efficacy of a simplified diagnostic and treatment pathway for muscle-invasive bladder cancer (MIBC). This study investigates the role of multiparametric bladder MRI (mpMRI) in patients with biopsy proven cancer of the bladder with clinical features of detrusor muscle invasion. In the experimental arm, enrolled patients will receive a bladder mpMRI, if this exam will confirm the high suspicion of muscle invasion a conventional endoscopic transurethral resection of bladder tumour (TURBt) for staging purposes will be foregone and patients will immediately access the next step of their clinical management. Experimental arm outcomes will be compared to a control arm in which all enrolled patients will be receiving TURBt as part of the standard management of bladder cancer. The aim of this study is demonstrating a significant reduction of the time needed to offer patients the definitive treatment for their disease, possibly ensuring better long-term oncological outcomes.
A blood sample will be collected from each patient enrolled in the study at pre-planned time points to measure the levels of circulating tumour (ctDNA), a primer will be built from bladder cancer biopsies performed at enrolment. ctDNA has been shown to be a proxy measure of tumour burden and residual molecular disease after treatment. The ctDNA levels in the experimental arm will be compared to those of the control arm to investigate wether foregoing endoscopic resection of the tumour and reducing time to definitive cancer treatment might be associated to lower ctDNA levels.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical suspicion of muscle invasive bladder cancer at cystoscopy and pre-cystoscopy imaging
排除标准
- •Anticipated survival < 3 months due to comorbidities
- •Pregnant patients
- •Breastfeeding patients
- •Previous chemotherapy within 6 weeks
- •Previous radiotherapy withing 6 weeks
- •Previous TURBt within 6 weeks
- •Severe renal impairment (eGFR < 40 mL/min/1.73 m2)
- •non MRI-compatible metal implants
- •Claustrophobia
- •Denial of written consent to participate in the study
研究组 & 干预措施
Standard Management
Patients enrolled in this arm will receive a flexible white light cistoscopy and concurrent cold-cup bladder tumour biopsy as part of the standard pathway at the sponsor Institution.
They will be booked for TURBt and be managed according to international guidelines.
If the pathology report of the TURBt will show muscle invasive bladder cancer, the clinical case will be discussed in the oncourological multidisciplinary board which will indicate the appropriate treatment.
Treatment will be discussed with patients in a shared decision making context and booked.
Management time monitoring will be conducted from the day of the cystoscopy until the day patients will receive the treatment indicated by the MDT.
干预措施: Transurethral resection of bladder tumour (TURBt) (Procedure)
Standard Management
Patients enrolled in this arm will receive a flexible white light cistoscopy and concurrent cold-cup bladder tumour biopsy as part of the standard pathway at the sponsor Institution.
They will be booked for TURBt and be managed according to international guidelines.
If the pathology report of the TURBt will show muscle invasive bladder cancer, the clinical case will be discussed in the oncourological multidisciplinary board which will indicate the appropriate treatment.
Treatment will be discussed with patients in a shared decision making context and booked.
Management time monitoring will be conducted from the day of the cystoscopy until the day patients will receive the treatment indicated by the MDT.
干预措施: Circulating tumour DNA levels assessment (Genetic)
Simplified Management
Patients enrolled in this arm will receive a flexible white light cistoscopy and concurrent cold-cup bladder tumour biopsy as part of the standard pathway at the sponsor Institution.
They will be booked for bladder mpMRI through a dedicated service at the sponsor Institution to assess the suspiscion detrusor muscle invasion by the tumour.
If the pathology report of the biopsy will show cancer and the mpMRI will confirm a high degree of suspicion for muscle invasive bladder cancer, the clinical case will be discussed in the oncourological multidisciplinary board which will indicate the appropriate treatment.
Treatment will be discussed with patients in a shared decision making context and booked.
Management time monitoring will be conducted from the day of the cystoscopy until the day patients will receive the treatment indicated by the MDT.
干预措施: multiparametric magnetic resonance imaging (mpMRI) of the bladder (Diagnostic Test)
Simplified Management
Patients enrolled in this arm will receive a flexible white light cistoscopy and concurrent cold-cup bladder tumour biopsy as part of the standard pathway at the sponsor Institution.
They will be booked for bladder mpMRI through a dedicated service at the sponsor Institution to assess the suspiscion detrusor muscle invasion by the tumour.
If the pathology report of the biopsy will show cancer and the mpMRI will confirm a high degree of suspicion for muscle invasive bladder cancer, the clinical case will be discussed in the oncourological multidisciplinary board which will indicate the appropriate treatment.
Treatment will be discussed with patients in a shared decision making context and booked.
Management time monitoring will be conducted from the day of the cystoscopy until the day patients will receive the treatment indicated by the MDT.
干预措施: Circulating tumour DNA levels assessment (Genetic)
结局指标
主要结局
Time to definitive treatment
时间窗: From the day of enrollment at baseline until the day of the start of definitive treatment for muscle invasive bladder cancer. Expected timeframe between 45 and 180 days.
Time in days needed to complete the diagnostic pathway, multidisciplinary board discussion and finally offer the appropriate definitive treatment for muscle invasive bladder cancer: surgery, drugs, radiation, palliative care
次要结局
- Concentration of ctDNA levels(Three specific time points: 1) Enrolment at baseline 2) During intervention (mpMRI or TURBt) 3) On the day of definitive treatment for muscle invasive cancer Expected timeframe 1 to 180 days)
- Overall Survival(through study completion, an average of 2 years)
- Cancer Specific Survival(through study completion, an average of 2 years)
- Time to cancer recurrence("through study completion, an average of 2 years".)
- Number of procedure Related Complications(For 30 days following the procedure)
研究者
Simone Albisinni
Associate Professor of Urology
University of Rome Tor Vergata