Phase 2, Multicenter, Prospective Cohort Study, Estimating the Efficacy of Focused HIFU Therapy in Patients With Localized Intermediate Risk Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 174
- 试验地点
- 14
- 主要终点
- patient proportion with controlled disease (Control of the pathology)
研究概览
简要总结
The aim of the focal treatment HIFU is to destroy the cancer without causing side effects in contrast to radical treatments. Radical treatments (surgery or radiation therapy) are the standard therapies for patient with intermediate risk localized prostate cancer and good life expectancy (prostatectomy if life expectancy10 years) By destroying only the part of the gland that harbors cancer, it may indeed be possible to provide efficient cure of the disease while minimizing treatment-induced morbidity (incontinence and loss of potency). Around 20% of patients presented with a unilateral tumor: this patients are currently treated radically. No study published papers reported outcomes of a large population (>100) with intermediate risk cancers treated with Focal-HIFU (conducted with the Focal One® device). Focal therapy must be only offer within clinical trial setting (EAU (European Association of Urology) Guidelines ). The aim of this cohort will be to determine the success rate of Focal-HIFU in this intermediate risk population. The result the study will be used for calculation the arms of a future random study
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
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patient having been clearly informed of the study and having accepted, with sufficient reflection time, to participate by signing the informed consent form of the study.
- •Age between 50 and 80 years with a life expectancy of more than 5 years. Patients between the ages of 75 and 80 will need to have a G8 score >
- •Initial diagnosis of localized prostate cancer (T1c or T2a) with the following characteristics:
- •A multiparametric MRI showing a single invasive tumor focus at most two contiguous sextants confirmed by biopsies (index tumor). Patients with multiple suspected MRI foci may be included if only one of these foci is confirmed by targeted biopsies.
- •Gleason score= 7 (3+4).
- •Tumor accessible to a Focal-HIFU treatment. For apical tumor, it must be localized more than 9 mm from the external sphincter
- •PSA ≤ 15ng / ml.
- •Patient affiliated with health insurance or beneficiary of an equivalent plan.
排除标准
- •Contraindications to treatment with HIFU-F:
- •Tumor not accessible.
- •Multiple intra prostatic calcifications inducing, on ultrasound, a shadow cone in the prostate preventing the penetration of ultrasound and thus the realization of the treatment.
- •History of pelvic irradiation
- •Presence of an implant (stent, catheter) located less than 1 cm from the treatment area.
- •Fistula of the urinary tract or rectum.
- •Anal or rectal fibrosis, anal or rectal stenosis or other abnormalities making it difficult to insert the Focal One® probe.
- •Anatomical abnormality of the rectum or rectal mucosa.
- •Patient with artificial sphincter, penile prosthesis or intra prostatic implant, eg stent.
- •History of intestinal inflammatory pathology.
- •Uro-genital infection in progress (the infection to be treated before HIFU treatment).
- •Anterior surgery at the level of the anus or rectum making the introduction of the probe impossible.
- •Allergy to latex.
- •Thickness of the rectal wall> 10mm.
- •TURP indication. Bladder neck incision is allowed.
- •Patient with a medical contraindication to Sonovue® injection.
- •Patient with a medical contraindication on MRI.
- •Patient already treated for prostate cancer (hormone therapy, radiotherapy, surgery).
- •History of uncontrolled cancer and / or treated for less than 5 years (with the exception of basal cell skin cancer).
- •History of pelvic radiotherapy.
- •History of sclerosis of the bladder neck or urethral stenosis.
- •Patient with a several bleeding risk according to medical advice (patient with oral anticoagulant therapy must receive an alternative therapy).
- •Patients with unstable neurological pathology.
- •Patient who has been treated for a therapeutic trial within 30 days of enrollment or who wishes to participate in an ongoing study that may interfere with this study.
- •Legal person protected by law.
- •Patient not able to understand the objectives of the study or refusing to comply with postoperative instructions.
研究组 & 干预措施
HIFU treatment
170 patients with prostate cancer of intermediate risk receive the immediate treatment with focal HIFU. The treatment area will be defined using MRI data and 3D biopsies. A safety distance of at least 9 mm will be defined around the tumor. An intraoperative contrast echocardiographic control will be performed to evaluate the necrotic area. If necessary, additional HIFU lesions will be performed during the same session. In case of residual tumor demonstrated during control biopsies, additional treatment of this tumor with focal HIFU may be proposed. Patients will also have PSA (Prostate-Specific Antigen) dosage, MRI (Magnetic Resonance Imaging) exam, questionnaires and prostatic biopsies during their follow up. If the patient decides to participate in the ancillary study, a blood test (for immunological analyzes and detection of CTC (circulating tumor cells)) and a urine test (for PCA3 (The prostate cancer antigen 3 gene) test) will be performed during their follow up.
干预措施: treatment with focal HIFU (Procedure)
HIFU treatment
170 patients with prostate cancer of intermediate risk receive the immediate treatment with focal HIFU. The treatment area will be defined using MRI data and 3D biopsies. A safety distance of at least 9 mm will be defined around the tumor. An intraoperative contrast echocardiographic control will be performed to evaluate the necrotic area. If necessary, additional HIFU lesions will be performed during the same session. In case of residual tumor demonstrated during control biopsies, additional treatment of this tumor with focal HIFU may be proposed. Patients will also have PSA (Prostate-Specific Antigen) dosage, MRI (Magnetic Resonance Imaging) exam, questionnaires and prostatic biopsies during their follow up. If the patient decides to participate in the ancillary study, a blood test (for immunological analyzes and detection of CTC (circulating tumor cells)) and a urine test (for PCA3 (The prostate cancer antigen 3 gene) test) will be performed during their follow up.
干预措施: PSA dosage (Biological)
HIFU treatment
170 patients with prostate cancer of intermediate risk receive the immediate treatment with focal HIFU. The treatment area will be defined using MRI data and 3D biopsies. A safety distance of at least 9 mm will be defined around the tumor. An intraoperative contrast echocardiographic control will be performed to evaluate the necrotic area. If necessary, additional HIFU lesions will be performed during the same session. In case of residual tumor demonstrated during control biopsies, additional treatment of this tumor with focal HIFU may be proposed. Patients will also have PSA (Prostate-Specific Antigen) dosage, MRI (Magnetic Resonance Imaging) exam, questionnaires and prostatic biopsies during their follow up. If the patient decides to participate in the ancillary study, a blood test (for immunological analyzes and detection of CTC (circulating tumor cells)) and a urine test (for PCA3 (The prostate cancer antigen 3 gene) test) will be performed during their follow up.
干预措施: MRI (Device)
HIFU treatment
170 patients with prostate cancer of intermediate risk receive the immediate treatment with focal HIFU. The treatment area will be defined using MRI data and 3D biopsies. A safety distance of at least 9 mm will be defined around the tumor. An intraoperative contrast echocardiographic control will be performed to evaluate the necrotic area. If necessary, additional HIFU lesions will be performed during the same session. In case of residual tumor demonstrated during control biopsies, additional treatment of this tumor with focal HIFU may be proposed. Patients will also have PSA (Prostate-Specific Antigen) dosage, MRI (Magnetic Resonance Imaging) exam, questionnaires and prostatic biopsies during their follow up. If the patient decides to participate in the ancillary study, a blood test (for immunological analyzes and detection of CTC (circulating tumor cells)) and a urine test (for PCA3 (The prostate cancer antigen 3 gene) test) will be performed during their follow up.
干预措施: Questionnaires (Other)
HIFU treatment
170 patients with prostate cancer of intermediate risk receive the immediate treatment with focal HIFU. The treatment area will be defined using MRI data and 3D biopsies. A safety distance of at least 9 mm will be defined around the tumor. An intraoperative contrast echocardiographic control will be performed to evaluate the necrotic area. If necessary, additional HIFU lesions will be performed during the same session. In case of residual tumor demonstrated during control biopsies, additional treatment of this tumor with focal HIFU may be proposed. Patients will also have PSA (Prostate-Specific Antigen) dosage, MRI (Magnetic Resonance Imaging) exam, questionnaires and prostatic biopsies during their follow up. If the patient decides to participate in the ancillary study, a blood test (for immunological analyzes and detection of CTC (circulating tumor cells)) and a urine test (for PCA3 (The prostate cancer antigen 3 gene) test) will be performed during their follow up.
干预措施: Prostatic biopsies (Procedure)
HIFU treatment
170 patients with prostate cancer of intermediate risk receive the immediate treatment with focal HIFU. The treatment area will be defined using MRI data and 3D biopsies. A safety distance of at least 9 mm will be defined around the tumor. An intraoperative contrast echocardiographic control will be performed to evaluate the necrotic area. If necessary, additional HIFU lesions will be performed during the same session. In case of residual tumor demonstrated during control biopsies, additional treatment of this tumor with focal HIFU may be proposed. Patients will also have PSA (Prostate-Specific Antigen) dosage, MRI (Magnetic Resonance Imaging) exam, questionnaires and prostatic biopsies during their follow up. If the patient decides to participate in the ancillary study, a blood test (for immunological analyzes and detection of CTC (circulating tumor cells)) and a urine test (for PCA3 (The prostate cancer antigen 3 gene) test) will be performed during their follow up.
干预措施: blood test (Biological)
HIFU treatment
170 patients with prostate cancer of intermediate risk receive the immediate treatment with focal HIFU. The treatment area will be defined using MRI data and 3D biopsies. A safety distance of at least 9 mm will be defined around the tumor. An intraoperative contrast echocardiographic control will be performed to evaluate the necrotic area. If necessary, additional HIFU lesions will be performed during the same session. In case of residual tumor demonstrated during control biopsies, additional treatment of this tumor with focal HIFU may be proposed. Patients will also have PSA (Prostate-Specific Antigen) dosage, MRI (Magnetic Resonance Imaging) exam, questionnaires and prostatic biopsies during their follow up. If the patient decides to participate in the ancillary study, a blood test (for immunological analyzes and detection of CTC (circulating tumor cells)) and a urine test (for PCA3 (The prostate cancer antigen 3 gene) test) will be performed during their follow up.
干预措施: urine test (Biological)
结局指标
主要结局
patient proportion with controlled disease (Control of the pathology)
时间窗: 12 months
The main objective is the estimation of FOCAL HIFU treatment efficacy defined as the percentage of positive biopsies in the treated lobe at 12 months after inclusion.
次要结局
- proportion of patients needing additional radical treatment(48 months)
- IIEF-5 score(over the 48 months)
- patient proportion with controlled disease (Control of the pathology)(48 months)
- proportion of patients needing additional treatment(48 months)
- Gleason score(48 months)
- Appearance of an extra capsular extension(48 months)
- Prostate cancer specific survival(48 months)
- Ancillary study: Measure of anti-tumoral immunity induction(over the 48 months)
- Recurrence free survival(48 months)
- rate of positive biopsies(48 months)
- Appearance of another cancerous focus in the other half of the prostate(48 months)
- Proportion of serious adverse effect(48 months)
- Quality of life score(over the 48 months)
- EPIC-26 score(over the 48 months)
- clinically significant cancer rate(48 months)
- Appearance of metastases(48 months)
- Overall survival(48 months)
- IPSS score(over the 48 months)
- Ancillary study: Measure of Circulating Tumor Cells (CTC) number reduction(over the 48 months)
- Ancillary study: Measure of ncRNA (non-coding RNA) PCA3 (Prostate cancer gene 3) level reduction.(over the 48 months)
- rate of positive biopsies(12 months)
- rate of positive biopsies(24 months)
- Appearance of metastases(24 months)
- Appearance of an extra capsular extension(12 months)
- Appearance of an extra capsular extension(24 months)
- proportion of patients needing additional treatment(12 months)
- proportion of patients needing additional radical treatment(12 months)
- Gleason score(12 months)
- Gleason score(24 months)
- Appearance of another cancerous focus in the other half of the prostate(12 months)
- Appearance of another cancerous focus in the other half of the prostate(24 months)
- Appearance of metastases(12 months)