Division of Surgery and Interventional Sciences, University College London, UK.
Contemp Clin Trials. 2013 Sep;36(1):68-80. doi: 10.1016/j.cct.2013.06.005. Epub 2013 Jun 14.
Focal therapy offers the possibility of cancer control, without the side effect profile of radical therapies. Early single centre prospective development studies using high intensity focused ultrasound (HIFU) have demonstrated encouraging genitourinary functional preservation and short-term cancer control. Large multi-centre trials are required to evaluate medium-term cancer control and reproduce functional recovery. We describe the study design of an investigator-led UK multi-centre, single arm trial using HIFU to deliver focal therapy for men with localised prostate cancer.
One-hundred and forty men with histologically proven localised low or intermediate risk prostate cancer (PSA < 15, Gleason ≤ 7, ≤ T2cN0M0) will undergo precise characterisation of the prostate using a combination of multi-parametric (mp)MRI and transperineal template prostate mapping (TPM) biopsies. Unilateral dominant tumours, the so-called index lesion, will be eligible for treatment provided the contra-lateral side is free of 'clinically significant' disease (as defined by Gleason ≥ 7 or maximum cancer core length ≥4 mm). Patients will receive focal therapy using HIFU (Sonablate 500®). Treatment effect will be assessed by targeted biopsies of the treated area and TPM biopsies at 36-months.
Primary outcome is the absence of clinically significant disease based on 36-month post-treatment TPM biopsies. Secondary outcomes address a) genitourinary function using validated patient questionnaires (IPSS, IPSS-QoL, IIEF-15, EPIC-Urinary, EPIC-Bowel, FACT-P, EQ-5D), b) the predictive validity of imaging, and c) risk factors for treatment failure.
INDEX will be the first multi-centre, medium term follow-up trial to evaluate the outcomes of a tissue preserving strategy for men with localised prostate cancer using the TPM-ablate-TPM strategy.
局部治疗提供了控制癌症的可能性，而没有激进治疗的副作用。 使用高强度聚焦超声（HIFU）的早期单中心前瞻性发展研究已经证明了令人鼓舞的泌尿生殖功能保留和短期癌症控制。 需要进行大型多中心试验来评估中期癌症控制并重现功能恢复。 我们描述了一项由研究者主导的英国多中心单臂试验的研究设计，该试验使用 HIFU 为局部前列腺癌男性提供局部治疗。
140 名组织学证实为局部低危或中危前列腺癌（PSA<15，Gleason≤7，≤T2cN0M0）的男性将使用多参数（mp）MRI 和经会阴模板前列腺图谱（TPM）活检相结合对前列腺进行精确描述。 单侧优势肿瘤，即所谓的索引病变，如果对侧无“临床显著”疾病（定义为 Gleason≥7 或最大癌核心长度≥4mm），则有资格接受治疗。 患者将接受 HIFU（Sonablate 500®）的局部治疗。 通过治疗区域的靶向活检和 36 个月时的 TPM 活检评估治疗效果。
主要结果是根据 36 个月后的 TPM 活检评估无临床显著疾病。 次要结果包括 a）使用验证后的患者问卷（IPSS、IPSS-QoL、IIEF-15、EPIC-Urinary、EPIC-Bowel、FACT-P、EQ-5D）评估泌尿生殖功能，b）评估影像学的预测有效性，c）治疗失败的危险因素。
INDEX 将是第一个评估使用 TPM-ablate-TPM 策略对局部前列腺癌男性进行组织保存策略治疗结果的多中心中期随访试验。
