Kanthabalan A, Shah T, Arya M, Punwani S, Bomanji J, Haroon A, Illing R O, Latifoltojar A, Freeman A, Jameson C, van der Meulen J, Charman S, Emberton M, Ahmed H U
Division of Surgery and Interventional Science, University College London, UK; Department of Urology, UCLH NHS Foundation Trust, UK.
Division of Surgery and Interventional Science, University College London, UK.
Contemp Clin Trials. 2015 Sep;44:175-186. doi: 10.1016/j.cct.2015.07.004. Epub 2015 Jul 13.
One-third of men may experience biochemical failure by 8years following radical radiotherapy for localised prostate cancer. Over 90% of men are started on androgen deprivation therapy (ADT) which is non-curative and confers systemic side-effects. Focal salvage therapy (FST) limits collateral tissue damage and may improve therapeutic ratios. In order to deliver FST, distant disease must be ruled-out and intra-prostatic disease must be accurately detected, localised and characterised.
FORECAST - Focal Recurrent Assessment and Salvage Treatment - is a study designed to evaluate a novel imaging-based diagnostic and therapeutic complex intervention pathway for men who fail radiotherapy.
Men with biochemical failure following radical prostate radiotherapy, prior to salvage therapy will be recruited. They will undergo whole-body multi-parametric MRI (WB-MRI), choline PET/CT, bone-scan and pelvic-mpMRI and then MRI transperineal-targeted biopsies (MRI-TB) and Transperineal Template Prostate Mapping Biopsy (TPM). Those suitable for FST will undergo either high intensity focused ultrasound (HIFU) or cryotherapy.
Primary outcome measures: a) the accuracy of WB-MRI to detect distant metastatic disease; b) accuracy of prostate mpMRI in local detection of radiorecurrent prostate cancer; c) detection accuracy of MRI-TB; and d) rate of urinary incontinence following FST.
Focal salvage therapy may confer lower rates of morbidity whilst retaining disease control. In order to deliver FST, intra- and extra-prostatic disease must be detected early and localised accurately. Novel diagnostic techniques including WB-MRI and MRI-TB may improve the detection of distant and local disease whilst reducing healthcare burdens compared with current imaging and biopsy strategies.
三分之一的男性在局限性前列腺癌接受根治性放疗后8年内可能出现生化复发。超过90%的男性开始接受雄激素剥夺治疗(ADT),这种治疗无法治愈且会带来全身副作用。局部挽救性治疗(FST)可减少对周围组织的损伤,并可能提高治疗效果。为了实施FST,必须排除远处疾病,并且必须准确检测、定位和表征前列腺内疾病。
FORECAST(局灶性复发评估与挽救治疗)是一项旨在评估一种基于成像的新型诊断和治疗综合干预途径的研究,该途径针对放疗失败的男性。
招募在接受挽救性治疗前前列腺根治性放疗后出现生化复发的男性。他们将接受全身多参数MRI(WB-MRI)、胆碱PET/CT、骨扫描和盆腔mpMRI,然后进行MRI经会阴靶向活检(MRI-TB)和经会阴模板前列腺图谱活检(TPM)。适合FST的患者将接受高强度聚焦超声(HIFU)或冷冻治疗。
主要结局指标:a)WB-MRI检测远处转移性疾病的准确性;b)前列腺mpMRI在局部检测放射性复发前列腺癌的准确性;c)MRI-TB的检测准确性;d)FST后尿失禁的发生率。
局部挽救性治疗可能在保持疾病控制的同时降低发病率。为了实施FST,必须早期检测并准确定位前列腺内和前列腺外疾病。与当前的成像和活检策略相比,包括WB-MRI和MRI-TB在内的新型诊断技术可能会提高对远处和局部疾病 的检测率,同时减轻医疗负担。