Initial Experience in Brazilian Single Center With High Intensity Focalized Ultrasound (HIFU) Prostate Cancer Therapy: Morbidity, Oncological and Functional Outcomes.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- Prostate cancer biochemical recurrence free survival after prostate cancer focal therapy
研究概览
简要总结
Prostate cancer (PCa) is the most prevalent non cutaneous cancer in occidental countries. In Brazil incidence was about sixty thousand new cases in 2016 and occupied second place as all cancer mortality, just behind lung cancer. Literature shows than younger patients tend to have more aggressive tumors rising cancer specific mortality scores. Main risk factors are age, life style (sedentary, high meat and fat intake) and family history (gene inheritance).
Besides vast advances in precocious tumors detection, challenges remain in the definition of the biological status of the tumor, which is highly variable and full of prognostic implications. PCa heterogeneity is demonstrated by the uncertain natural history, varying from indolent lesion to aggressive metastatic and fast progression cancer resistant to conventional therapies. In an actual treatment scenario, prognostic identification is the cornerstone of daily practice treatment considering the natural history variability cited before and the discrepancy of long term slow growth (studies estimate eight to sixteen years of tumor growth to achieve metastatic disease) to high grade aggressive cancer.
Considering all this background and taking in account the indolent evolution of low risk PCa new therapies emerge with promising outcomes. High-Intensity Focused Ultrasound (HIFU) have to be highlighted due to easy operation, good oncologic results and low complication profile. The method is based on real-time imaging guided high intensity ultrasound (US) causing overheat and cavitation in the focused tissue. Applied since 90's, mainly in German and French groups, initially programmed to treat hole gland preserving only urinary sphincter and bladder neck, showed recently some data on 1700 patients, 5 years biochemical recurrence free survival of 80% and best results including morbidity profile in low risk, low prostate volume and in the group with previous trans urethral prostate resection (TURP). This results are very similar to other radical treatment options with median follow up of 8 years, cancer specific survival 98% and metastasis free survival of 95% If local recurrence was identified another HIFU ablation or even radical treatment achieved good results in local control with acceptable morbidity profile.
Focal treatment is a new entity in PCa therapy. One randomized trial compared focal treatment to active surveillance in 513 mans with PCa diagnosis. With a 24 month follow-up progression-free ratios (28% x 58%) and positive control prostate biopsy ratios (14% x 49%) were fairly superior in treatment group. This exiting novel data turns urological oncology paths to the new era of minimally harmful therapy with targeted focused procedure. At our knowledge there is no high evidence clinical trial comparing HIFU to active surveillance.
The objective of this study is to evaluate prospectively the initial experience with 50 patients submitted to HIFU therapy for low risk prostate cancer in Brazilian single center considering the following aspects:
One year of treatment prostate biopsy positiveness; Biochemical recurrence free survival using Phoenix and Stuttgart criteria in one year; Sexual function using IIEF-5 questionnaire and the usage of 5-phosphodiesterase inhibitors (5-PDI); Urinary symptoms using EPIC and IPSS questionnaires and free urinary flow; Quality of life based on SF-36 questionnaire evaluation; Post procedure morbidity using Clavien-Dindo classification.
详细描述
Prostate cancer (PCa) is the most prevalent non cutaneous cancer in occidental countries. In Brazil incidence was about sixty thousand new cases in 2016 and occupied second place as all cancer mortality, just behind lung cancer. Literature shows than younger patients tend to have more aggressive tumors rising cancer specific mortality scores. Main risk factors are age, life style (sedentary, high meat and fat intake) and family history (gene inheritance).
Screening programs suggested by urological and oncologic societies, mainly based on Prostate Specific Antigen (PSA), changed natural history of this disease, overturning past late diagnosis with advanced disease to early discover in present days, with localized highly curable cancer by local therapy (surgery or radiation therapy) turning focus on morbidity status based on the high long term cancer specific survival.
Besides vast advances in precocious tumors detection, challenges remain in the definition of the biological status of the tumor, which is highly variable and full of prognostic implications. PCa heterogeneity is demonstrated by the uncertain natural history, varying from indolent lesion to aggressive metastatic and fast progression cancer resistant to conventional therapies. In an actual treatment scenario, prognostic identification is the cornerstone of daily practice treatment considering the natural history variability cited before and the discrepancy of long term slow growth (studies estimate eight to sixteen years of tumor growth to achieve metastatic disease) to high grade aggressive cancer.
Aiming to reduce PCa cancer specific mortality, PSA tests associated with digital rectal examination are the actual standard of care in PCa screening. A randomized clinical trial demonstrated reduction in the risk of PCa death up to 25% in patients maintaining regular screening. Risk stratification after tumor diagnosis includes nomograms, most used is D'Amico score stratifying low, intermediate and high risk cancer based on PSA value, digital rectal examination, tumor histology and volume. Considering the risk, treatment may be localized, systemic or active surveillance.
Three randomized trials compared active surveillance with local treatment, one showing benefit in cancer specific survival with 40% reduction and other two demonstrating comparable outcomes. Considering this studies results, one important detail was related to metastasis, pointing that metastasis free survival was better for the treatment group compared to surveillance. Based on this studies active surveillance was introduced in guidelines and clinical practice with the benefits of minimizing morbidity and disadvantage of slightly higher risk of metastasis and local complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •1. Patients with recent diagnosis of usual adenocarcinoma of prostate untreated and with indication of specific treatment by the assisting urologist;
- •2. And low or intermediate prostate cancer in clinical staging;
- •3. And concordance with the clinical trial by signing the terms.
排除标准
- •1. Other types of prostate cancer not usual adenocarcinoma;
- •2. Or any previous treatment to prostate cancer;
- •3. Or any patient who presents with proctologic abnormalities;
结局指标
主要结局
Prostate cancer biochemical recurrence free survival after prostate cancer focal therapy
时间窗: 12 months
Biochemical recurrence free survival using Phoenix criteria in one year
Prostate cancer pathological persistence after prostate cancer focal therapy
时间窗: 12 months
One year post-HIFU treatment prostate biopsy positivity
次要结局
- IIEF-5 - Sexual function after prostate cancer focal therapy(12 months)
- 5-PDI - Sexual function after prostate cancer focal therapy(12 months)
- Free urinary flow - Urinary symptoms after prostate cancer focal therapy(12 months)
- Quality of life after prostate cancer focal therapy(12 months)
- EPIC - Urinary symptoms after prostate cancer focal therapy(12 months)
- Morbidity after prostate cancer focal therapy(12 months)
- IPSS - Urinary symptoms after prostate cancer focal therapy(12 months)