Active Surveillance Plus (AS+): Local Tumor Control With High-intensity Focused Ultrasound (HIFU) in Patients With Localized Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Number of patients without clinically significant prostate cancer
研究概览
简要总结
PSA (Prostate-specific antigen) testing has significantly increased the number of men diagnosed with prostate cancer (PCa) and especially patients with low and intermediate risk disease. The effect of radical treatment (treatment of the entire prostate gland) in these risk groups is disputable while the risk of adverse effects, with erectile dysfunction and urinary incontinence, is not. Active surveillance (AS) has been developed as an alternative to radical treatment with the aim of avoiding or delaying radical treatment by closely monitoring for signs of tumor progression. Active surveillance is regarded as the treatment of choice for low-risk prostate cancer. Focal therapy may have a crucial role in improving active surveillance protocols for patients with intermediate localized prostate cancer. Focal eradication of the index-tumor may delay or avoid indefinitely radical treatment for this patient group while significantly reducing treatment-related side effects. Improved MRI-diagnostics and MRI/ ultrasound fusion technology have optimized tumor mapping and classification and this in turn has made partial treatment of the prostate a feasible treatment option.
This study is a prospective cohort study. Patients with intermediate (high-risk) localized PCa and a visible index tumor will be treated with high-intensity focused ultrasound (HIFU).
The aim of the study is to show that there is a significant effect of focal treatment on surveillance biopsies and a reduced conversion to radical treatment, without compromising survival outcomes compared to historical controls (retrospective cohort). A cohort from the more than 450 patients included in the local AS-protocol with MRI at Vestfold hospital trust since 2009 will serve as controls.
详细描述
1 Needs description It is unclear if eradication with focal treatment of the index-tumor of patients with intermediate-risk prostate cancer followed by active surveillance can reduce the need for radical, whole-gland treatment of the prostate and thereby treatment side effects. It is important for urologists and patients to know if focal treatment of prostate cancer is both a safe and effective treatment option. If proven so, focal treatment of prostate cancer can be offered as a viable, intermediate treatment option for a large group of patients who currently only have the choice between either surveillance or radical treatment.
Thus, there is an unmet need to document the outcome of focal treatment in selected patients with prostate cancer, both in terms of efficacy and safety
- Hypotheses, aims and objectives
2.1 Hypothesis: Focal treatment of biopsy-verified, localized, MRI-visible, intermediate-risk (and high-risk fo elderly patients) prostate cancer is a safe and effective treatment option. Side effects following focal treatment are transient and mild compared to established and well-documented radical treatment options.
2.2 Aims of the study: To investigate if focal treatment of localized prostate cancer followed by MRI-supplemented active surveillance conveys sufficient tumor control to enable patients to continue indefinitely in this follow-up protocol without the need to convert to radical treatment, with none or mild side effects and without compromising oncological outcomes.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •* Age 55-80 years
- •* Life expectancy \>10 years
- •* Gleason-score:
- •* patients \<75 years: Gleason score \< 8
- •* patients 75-80 years: Gleason \<9
- •* TNM-stage: clinical/ radiological stage \ 15 should be counseled with caution (does not apply to patients \>75 years)
- •* Risk group: d'Amico intermediary risk group, open for high risk patients age \>75 years
排除标准
- •Previous treatment
- •Previous treatment of the primary cancer within the prostate
- •Previous hormone treatment for prostate cancer within 6 months before trial
- •Previous radiation to pelvis
- •Acute urinary tract infection
- •For patients <75 years: >5% chance of lymph node metastases calculated by the updated prostate cancer staging nomogram (Partin tables) (30)
- •Radiological imaging:
- •PI-RADS score <3, clinical significant cancer is equivocal
- •Extracapsular extension or seminal vesicle invasion
- •Lymph node or bone metastasis
- •> 2 MRI detected tumors validated by systematic or MRI-guided biopsies
- •Contraindications for MRI
结局指标
主要结局
Number of patients without clinically significant prostate cancer
时间窗: 1-10 years
Absence of clinically significant prostate cancer (Gleason grade ≥7A) on post-treatment systematic and targeted biopsies
Measurement of functional results
时间窗: 1-10 years
erectile function, continence, and other therapy-related complications. Questionnaire-based.
Number of patients who need repeated focal treatment
时间窗: 1-10 years
recurrence and recurrent treatment
Number of patients eligible for continuous AS+
时间窗: 1-10 years
Disease-free survival
时间窗: 1-10 years
based on repeated MRI and repeat biopsies performed on clinical/ radiological suspicion
Treatment-free survival
时间窗: 1-10 years
Overall survival
时间窗: 1-10 years
Metastasis-free survival
时间窗: 1-10 years
Number of patients who need radical (surgery or radiation), or palliative treatment (hormone therapy)
时间窗: 1-10 years
次要结局
- Number of patients where MRI predicted tumor recurrence/ tumor absence(1-10 years)
- Patient Reported Outcomes Measures(1-10 years)
研究者
Sven Löffeler
Principal Investigator
The Hospital of Vestfold