A Multicentre Randomised Active Surveillance (AS) Trial of Current Practice Versus Standardised Triggers for Curative Treatment of Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 195
- 试验地点
- 5
- 主要终点
- Progression-free survival
研究概览
简要总结
A large proportion of men with prostate cancer are overdiagnosed and overtreated mainly due to PSA testing. Active surveillance (AS) aims to reduce these harms by recommending curative treatment only when and if signs of tumour progression occur. There are however a number of uncertainties in AS, the most important being when to initiate treatment.
Therefore, the Scandinavian Prostate Cancer Group (SPCG) are running a large multi-centre randomised control trial (RCT) to test the safety of a standardized active surveillance protocol with specific triggers for repeat biopsies and initiation of curative treatment, compared to the current practice for active surveillance. They are recruiting in multiple sites in Sweden, Denmark and Finland. The primary aim is to reduce overtreatment and subsequent side effects, without increasing the risk of disease progression or prostate cancer mortality.
In the UK, there is also no set criteria for when to re-biopsy and/or initiate curative treatment for patients on AS and tends to be at the clinician's discretion. Thus, PCASTT-UK has been established to run as a parallel RCT and add to the findings from SPCG-17.
详细描述
STUDY HYPOTHESIS The aim of this trial is to test the safety of an Active Surveillance protocol comparing current practice to standardized triggers for initiation of curative treatment, based on Magnetic Resonance Imaging or biopsy pathology. The study hypothesis is that standardized triggers will reduce overtreatment without increasing disease progression and prostate cancer mortality.
STUDY DESIGN Randomized multi-centre open-label clinical trial.
INTERVENTIONS Patients within 12 months of a diagnosis of prostate cancer will be approached and consented to the study. Computerised randomisation (1:1) will assign participants to either the control (Arm 1) or intervention arm (Arm 2). In the control arm, patients will be treated according to active surveillance protocol at the trial centre; in the intervention arm patients will follow standardised active surveillance protocol applying specific criteria for repeat biopsies and the initiation of curative treatment. Patients are stratified by centre and Gleason score.
FOLLOW UP In both arms, patients will followed up for 10 years with the following schedule: a PSA test every 6 months, clinical examination (with PSA test) and Quality of Life (QoL) questionnaire annually, and MRI every second year. Re-biopsy and/or initiation of curative treatment depends on the trial arm patients are randomised to.
Repeat biopsies
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
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Recently (within 12 months) diagnosed adenocarcinoma of the prostate
- •Tumour stage ≤ T2a, NX, M0 (former MX)
- •PSA <15ng/ml, PSA density ≤ 0.2 ng/ml/cm3
- •Gleason pattern 3+3=6 (any number of cores, any cancer involvement) or Gleason pattern 3+4=7 (<3 cores (or ≤30 % of cores if more than ten cores), <10 mm cancer in one core)
- •Life expectancy >10 years with no upper age limit*
- •Candidate for curative treatment if progression occurs
- •Signed written informed consent.
- •There is no upper age limit; however the estimated remaining lifetime for the patient should be more than ten years. The potential life expectancy of the participants should be estimated based on age, co-morbidity and risk factors for death, such as frailty and smoking.
排除标准
- •Not eligible for AS according to above criteria
- •Not competent in spoken or written English
结局指标
主要结局
Progression-free survival
时间窗: Median 10 years follow-up
Progression-free survival is defined as cumulative incidence of PSA relapse following curative treatment and cumulative incidence of androgen therapy in untreated men. Following radical prostatectomy, biochemical recurrence is defined by two consecutively rising PSA values \>0.2 ng/ml. After radiotherapy (RT) with or without androgen deprivation therapy, the definition of PSA failure is any rise by 2 ng/ml or more above the nadir PSA value, regardless of the serum concentration of the nadir.
次要结局
- Cumulative incidence of pT3 at radical prostatectomy specimens(Median 10 years follow-up)
- Cumulative incidence of metastases(Median 10 years follow-up)
- Cumulative incidence of switch to watchful waiting(Median 10 years follow-up)
- Quality of life assessed by EPIC-26 score, incontinence, erectile dysfunction, self-reported quality of life: questionnaires(Median 10 years follow-up)
- Cumulative number of treatments with curative intent (mainly radical prostatectomies or local radiotherapy)(Median 10 years follow-up)