Prospective Phase II Trial of Single Fraction Real-time High-Dose-Rate (19-HDR) Brachytherapy in Patients With Low and Intermediate Risk Prostate Cancer
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- Safety measured by i) urinary retention rate and duration ii) maximum International Prostate Symptom Score and time to normalize
研究概览
简要总结
High-dose rate brachytherapy (HDR-BT) is an advanced technology theorized to be more advantageous than LDR-BT and External Beam Radiotherapy (EBRT), to the patient himself, and in terms of resource allocation. Studies of HDR-BT monotherapy have encouraging results in terms of biochemical control, patient survival and toxicity, but there are still certain limitations that preclude recommending HDR-BT monotherapy outside the setting of a clinical trial.
The primary endpoint of this study is to evaluate the safety, tolerance and impact on quality of life (QoL) of the BT-HDR 19Gy administered in single fraction in patients with low and intermediate risk prostate cancer. Secondary endpoint is to measure the efficacy, in terms of cancer control and satisfaction of the patients undergoing the experimental treatment.
Forty nine patients will be recruited for the experimental procedure Quality of Life, tolerance, gastrointestinal and genitourinary toxicity will be assessed using standardized procedures and scales. Patient satisfaction with the procedure will be appraised using five-category predetermined Likert scale questions.
Two different types of intermediate analyses will be performed: with 15 and 30 recruited patients.
The experimental treatment tested in this study is very innovative. Since prostate cancer is the most frequent cancer in men in Spain, this trial results are very likely to have a major impact on the standard therapy for prostate cancer in our National Health Service, allowing for a higher number of Hospitals within our country and other countries starting protocols of HDR BT 19Gy in single fraction.
详细描述
Treatment:
The patient´s treatment will consist of MRI-TRUS fusion single HDR brachytherapy fraction (1 fraction of 1900 cGray).
Brachytherapy performed under general anesthesia as an outpatient procedure
TRUS-MRI fusion:
T2 axial volumetric sequence (VISTA) is imported directly from the picture archiving and communication systems (PACS). Then MR images are reconstructed and segmented. Target volumes (prostate gland, dominant intraprostatic lesions (DILs) Organs at risk (OARs) urethra and rectum are delineated.
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
- •Men older than 18 years old
- •Histologically confirmed diagnosis of adenocarcinoma of the prostate
- •Clinical stage T1c/T2a disease
- •Low and Intermediate risk disease defined as either Gleason 6 or Gleason 7 and PSA < 20 ng/ml.
- •Prostate volume < 60 cc as determined by ultrasound, CT or MRI
- •Life expectancy of more than 10 years
- •Willing to give informed consent to participate in this clinical trial
- •Able and willing to complete Expanded Prostate Index Composite (EPIC) questionnaire
- •Eastern Cooperative Oncology Group (ECOG) of 0 -
- •Give competent informed consent to participate in this trial.
排除标准
- •Documented nodal or distant metastases
- •Previous pelvic radiotherapy
- •Previous trans-urethral resection of prostate, previous prostatectomy or HIFU
- •Use of androgen deprivation therapy. Use of 5-alpha-reductase inhibitors is permitted
- •Poor baseline urinary function defined as International Prostate Symptom Score (IPSS) >19
- •Contra-indication to radical prostate radiotherapy
- •Significant medical co-morbidity rendering patient unsuitable for general anaesthetic
结局指标
主要结局
Safety measured by i) urinary retention rate and duration ii) maximum International Prostate Symptom Score and time to normalize
时间窗: 12 months
Data to be collected are: i) urinary retention rate and duration ii) maximum International Prostate Symptom Score and time to normalize
Quality of Life measured by alidated instruments including International Prostate Symptom Score and the urinary, bowel and sexual domains of EPIC
时间窗: 12 months
Quality of life will be measured through validated instruments including International Prostate Symptom Score and the urinary, bowel and sexual domains of EPIC
次要结局
- Patient satisfaction measured with Likert scale question(24 months)
- Efficacy, measured by PSA(24 months)
- Acute toxicity measured by urinary retention rate, International Prostate Symptom Score over time, rectal toxicity and genitourinary toxicity(24 months)
研究者
Alfonso Gomez-Iturriaga
Staff physician department of Radiation Oncology
Hospital de Cruces