Feasibility Study of Image-guided, Dynamic Dosimetry for Permanent Interstitial Prostate Brachytherapy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Evaluation of the feasibility of using the RUF system.
研究概览
简要总结
This will be a phase I study. This phase I study is not a standard drug dose escalation study, but rather a Clinical System Performance Evaluation Trial of a therapeutic device. However for purposes of this protocol we will refer to this portion of the trial as a phase I study.
The purpose of this study is to demonstrate the feasibility and clinical practicability of the registered ultrasound and fluoroscopy (RUF) in combination with CMS Interplant system® in an initial cohort of 6 patients.
This will involve demonstrating the feasibility of using the system in an actual operating room environment as well as obtaining a preliminary assessment of the accuracy and performance of the source location algorithm by comparing with postoperative CT dosimetry.
The Primary endpoint of this study will be evaluation of the feasibility of using the RUF system and of performing real-time optimization in the operating room environment.
The Secondary endpoints of this study will be:
- Acute and late toxicity as assessed by IPSS, SHIM, and EPIC questionnaires at multiple follow-up intervals.
- PSA-free survival.
Study Population:
The target population will be patients with a diagnosis of adenocarcinoma of the prostate who are seen in consultation at the Johns Hopkins Hospital.
Approximately 360 patients per year with the diagnosis of prostate cancer are seen in the Department of Radiation Oncology at Johns Hopkins Hospital. Of these patients, approximately 45% have low-risk (T1a-T2a, Gleason 6 or less, PSA 10 ng/ml or less) or intermediate-risk disease and are suitable for brachytherapy based on disease risk. Within this group of patients, approximately 70% are eligible for brachytherapy based on gland size and no prior transurethral resection of prostate (TURP).
Approximately 80% of patients offered brachytherapy at consultation decide to receive their treatment at Johns Hopkins. Overall, we currently perform 2 brachytherapy procedures per week on average, for a yearly total of approximately 90 cases.
For purposes of homogeneity of treatment and patient population, this protocol will only enroll patients currently treated at this institution with brachytherapy alone, and will not enroll patients (intermediate or high risk disease) who will require external beam radiation in addition to brachytherapy.
详细描述
This will be a prospective Phase I study.
Subject Identification: Patient confidentiality will be maintained in accordance with Health Information Portability and Accountability Act (HIPAA) guidelines.
All participants must sign an informed consent that will describe the objectives of the study and potential risks. All patient data reported on the case reports forms will be identified by the patient's initials and study code number only.Patients shall not be identified by name. This should serve to protect the confidentiality of subjects enrolled on the trial. Clinical data and records for all subjects studied including history and physical findings, laboratory data, and results of interventions are to be maintained by the investigators in a secure, locked location. Computerized data will require password authorization(s) for access.
Description of the Recruitment Process:
Potential subjects will be identified at the time of consultation in the Department of Radiation Oncology by Dr. Song or Dr. DeWeese. If Dr. DeWeese identifies a potential patient during a consult he will refer them to Dr. Song so that Dr. Song can offer the patient the opportunity to participate. Dr. DeWeese will not offer patients the opportunity to participate but will only assist in identifying potential patients for the research team as he sees many brachytherapy cases during his consultations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 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, locally confined adenocarcinoma of the prostate
- •PSA of less than 10 ngmL
- •Combined Gleason score 6 or less, with no individual Gleason score of 4 or 5
- •The patient has decided to undergo brachytherapy at the Johns Hopkins Hospital as treatment choice for his prostate cancer
- •Karnofsky Performance Status greater than 70
- •Prostate volume by TRUS less than 50 cc
- •International Prostate symptom score must be 18 or less
- •Signed study-specific consent form prior to registration
排除标准
- •Clinical or Pathological Lymph node involvement,
- •Evidence of distant metastases
- •Radical surgery for carcinoma of the prostate
- •Chemotherapy or pelvic radiation therapy
- •Previous transurethral resection of the prostate
- •Previous or concurrent cancers other than basal or squamous cell skin cancers unless disease free for at least 5 years.
- •Significant obstructive symptoms
- •Major medical or psychiatric illness which, in the investigator's opinion, Hip prosthesis
- •Anatomic or medical condition (such as prior abdominal perineal resection or anal stricture) which would preclude the use of TRUS Implanted device or apparatus which might obstruct visibility of the implanted sources on fluoroscopy
结局指标
主要结局
Evaluation of the feasibility of using the RUF system.
时间窗: 5 years
Evaluation of real-time optimization in the operating room environment.
时间窗: 5 years
次要结局
- Acute & late toxicity as assessed by IPSS, SHIM, & EPIC questionnaires.(5 years)
- PSA-free survival.(5 year)