High-Dose-Rate Prostate Brachytherapy Combined With Stereotactic Ablative Prostate Radiotherapy for Patients Diagnosed With Intermediate and High-risk Prostate Cancer. Phase II Clinical Trial.
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Deterioration of patient quality of life as assessed by EPIC-26 (The Expanded Prostate Cancer Index Composite short form)
研究概览
简要总结
Dose escalation is nowadays a standard strategy in radiotherapy for prostate cancer. Besides, it is believed that due to the radiobiology characteristics of prostate cells (low alpha/beta ratio), the delivery of higher radiation doses per fraction could theoretically improve the efficacy of the treatment. In this context, the combination of prostate brachytherapy and external beam radiotherapy (EBRT) has proven to be the most effective method of dose escalation significantly improving disease control in randomized clinical trials. Unfortunately, this strategy is also associated with an increased risk of acute and late adverse events compared to conventional EBRT alone. It has been proposed that this increase in adverse events could be related to the use Low-Dose-Rate (LDR) brachytherapy and that High-Dose-Rate (HDR) brachytherapy (a more modern and accurate procedure) could reduce this risk.
On the other hand, Stereotactic Ablative Radiotherapy (SABR) is a high-precision radiation technique that allows the delivery of higher doses per fraction in fewer sessions, reducing the total treatment time.
The investigators hypothesized that the combination of two highly conformal radiation techniques (HDR brachytherapy and SABR) could be well tolerated, while reducing total treatment time and therefore improving patient quality of life.
This is a single arm Phase II clinical trial designed to test the feasibility, tolerability and impact on quality of life of the combination of High-Dose-Rate prostate brachytherapy and SABR for patients with intermediate and high-risk prostate cancer.
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 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed diagnosis of adenocarcinoma of the prostate.
- •Intermediate or high-risk disease (as per NCCN criteria):
- •Intermediate risk:
- •Clinical stage ≤ T2c
- •Gleason score 7 and initial PSA ≤ 20 ng/ml.
- •Gleason score ≤ 6 and initial PSA > 10 and ≤ 20 ng/ml.
- •High risk,at least one of the following:
- •Clinical stage T3a-b.
- •Gleason score 8-
- •Initial PSA > 20 ng/ml.
- •Life expectancy of more than 10 years
- •Able and willing to complete Expanded Prostate Index Composite (EPIC) end EORTC questionnaires
- •Eastern Cooperative Oncology Group (ECOG) of 0 -
- •Willing to give informed consent to participate in this clinical trial
- •Give competent informed consent to participate in this trial.
排除标准
- •Documented nodal or distant metastases.
- •Previous pelvic radiotherapy.
- •Clinical stage T
- •Clinical stage T3a or T3b in which the coverture of the extraprostatic disease is not feasible (as deemed by the treating physician).
- •Prostate volume > 70 cc (measured on MRI).
- •Poor baseline urinary function defined as International Prostate Symptom Score (IPSS) >17
- •Contra-indication to radical prostate radiotherapy
- •Significant medical co-morbidity rendering patient unsuitable for general anaesthetic
结局指标
主要结局
Deterioration of patient quality of life as assessed by EPIC-26 (The Expanded Prostate Cancer Index Composite short form)
时间窗: 24 months
Impact on Quality of life affecting the genitourinary, gastrointestinal, sexual and hormonal domains using the EPIC-26 short form (graded from 0-100, with higher scores representing better quality of life). Baseline value (i.e. prior to treatment) will be compared to values recorded 1 month, 3 months, 12 months and 24 months after treatment.
Deterioration of patient quality of life as assessed by EORTC (European Organisation for Research and Treatment of Cancer) QLQ-PR25 short form.
时间窗: 24 months
Impact on Quality of life affecting the genitourinary, gastrointestinal, sexual and hormonal domains using the EORTC QLQ-PR25 short form (items and scale scores of the QLQ-PR25 are linearly transformed to a 0-100 scale, with higher scores reflecting either more symptoms (urinary, bowel, hormonal treatment-related symptoms) or higher levels of functioning (sexual).). Baseline value (i.e. prior to treatment) will be compared to values recorded 1 month, 3 months, 12 months and 24 months after treatment.
Incidence and severity of genitourinary treatment-related acute adverse events graded according to CTCAE (Common Terminology Criteria for Adverse Events) v5.0 scale.
时间窗: 3 months
Every urinary event occurring within 3 months from treatment completion will be defined as "acute event". All adverse events will be recorded and graded according to CTCA V5.0 scale (graded from 0-5 with greater values representing worse outcomes)
Incidence and severity of gastrointestinal treatment-related acute adverse events graded according to CTCAE (Common Terminology Criteria for Adverse Events) v5.0 scale.
时间窗: 3 months
Every gastrointestinal event occurring within 3 months from treatment completion will be defined as "acute event". All adverse events will be recorded and graded according to CTCA V5.0 scale (graded from 0-5 with greater values representing worse outcomes)
Incidence and severity of genitourinary treatment-related late adverse events graded according to CTCAE (Common Terminology Criteria for Adverse Events) v5.0 scale.
时间窗: 24 months months
Every genitourinary event occurring 3 months after treatment completion will be defined as "late event". All adverse events will be recorded and graded according to CTCA V5.0 scale (graded from 0-5 with greater values representing worse outcomes) 6 months, 12 months and 24 months after treatment.
Incidence and severity of gastrointestinal treatment-related late adverse events graded according to CTCAE (Common Terminology Criteria for Adverse Events) v5.0 scale.
时间窗: 24 months months
Every gastro-intestinal event occurring 3 months after treatment completion will be defined as "late event". All adverse events will be recorded and graded according to CTCA V5.0 scale (graded from 0-5 with greater values representing worse outcomes) 6 months, 12 months and 24 months after treatment.
次要结局
- Treatment efficacy in biochemical control measured through PSA (prostate specific antigen) level.(24 months)
研究者
David Büchser
Radiation Oncology Consultant, Principal Investigator.
Biocruces Bizkaia Health Research Institute