Phase II Study of Dose Escalation to Dominant Intraprostatic Lesions (DIL) With MRI-TRUS Fusion Real Time High Dose Rate (HDR) Brachytherapy in Patients With Intermediate and High Risk Prostate Cancer
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Feasibility of delivery higher than prescription doses (at least 125% of the dose)using inverse planned MRI-TRUS fusion high dose rate (HDR) brachytherapy.
研究概览
简要总结
The Magnetic Resonance (MR) provides high resolution of soft tissue images allowing an appropriate assessment of the local extent of the disease. Recent studies have shown an increase in sensitivity and specificity for the detection of Dominant intraprostatic lesions when using multiparametric MRI as a diagnostic tool in the staging of the disease.
Among the various irradiation techniques currently available for prostate cancer, Brachytherapy is the superior in terms of dose conformation; this conformation allows greater dose escalation, adjusting the isodoses to the prostate with exquisite accuracy, keeping healthy adjacent organs, such as the urethra and rectum, in a tolerable dose range
Brachytherapy companies have recently developed software allowing for TRUS-MR image fusion.
The purpose of this study is to demonstrate the feasibility of the delivery of a higher than prescription dose to the dominant intra-prostatic nodule as defined on multiparametric MRI.
Dose to prostate, and adjacent structure will remain the same as the current treatment practice. Timing and the delivery of brachytherapy will not change from our current practice
详细描述
Treatment:
The patient's treatment will consist of combined Hypofractionated external beam (3750 cGray in 15 fractions) and MRI-TRUS fusion HDR brachytherapy boost (1 fraction of 1500 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)and 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 ≥18 years
- •Histologically proven adenocarcinoma of the prostate
- •Intermediate or high risk prostate cancer
- •Intermediate risk prostate cancer patients must have:
- •Clinical stage ≤ T2c, Gleason score = 7 and iPSA ≤ 20, or Gleason score ≤ 6 and iPSA > 10 and ≤
- •High risk patients may have Clinical stage T3 Gleason score 8-10 PSA > 20 ng/ml
- •A palpable nodule or a cluster of positive biopsies from a single region suggesting the presence of dominant nodule and with radiologic correlation by MRI.
- •Estimated life expectancy of at least 10 years.
- •ECOG performance status of 0 -
- •Signature of informed conseny
排除标准
- •Contraindications to interstitial prostate brachytherapy.
- •If on coumadin therapy and NOT able to stop safely for 7 days.
- •Does not have a localized high volume of intraprostatic disease and MRI contraindicated
- •Unfit for general anesthetic
研究组 & 干预措施
MRI-TRUS fusion guided real time HDR
Patients treated with dose escalation to Dominant Intraprostatic Lesions
干预措施: MRI-TRUS fusion guided real time HDR (Radiation)
结局指标
主要结局
Feasibility of delivery higher than prescription doses (at least 125% of the dose)using inverse planned MRI-TRUS fusion high dose rate (HDR) brachytherapy.
时间窗: 12 months
Use the multiparametric MRI to identify dominant intraprostatic lesions (DIL) and deliver higher doses to these lesions with real time HDR brachytherapy. The procedure will be considered feasible if DIL is covered by the 125% of prescription dose while respecting tolerance doses of adjacent normal organs
次要结局
- Efficacy assessed by PSA, Multiparametric MRI and prostate biopsy(30 months)
- Acute toxicity and tolerability compared to the historic cohort of patients treated with standard HDR brachytherapy(24 months)
研究者
Alfonso Gomez-Iturriaga
Staff physician department of Radiation Oncology
Hospital de Cruces