FTPC (Focal Therapy for Prostate Cancer): A Pilot Study Using Focal Low Dose Rate Brachytherapy as an Alternative to Active Surveillance and Radical Treatment for Favourable Risk Prostate Cancer.
试验速览
- 阶段
- 不适用
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Constitute Disease Criteria and Appropriate Treatment Plans
研究概览
简要总结
This project will develop and evaluate a treatment plan for prostate focal therapy based on low dose rate brachytherapy. The participants entering this study are those suitable for active surveillance. These participants will be monitored with various imaging methods and interventions such as MR elastography, Transrectal ultrasound elastography, PET/CT and transperineal mapping biopsy to determine the extent of cancer and suitable treatments. Those suitable for focal therapy will be offered the option of low dose rate brachytherapy (LDRB) focal therapy in addition to active surveillance or radical therapy.
This study will be used to evaluate the long term use of multi-modal, multi-parametric prostate cancer imaging, combining data from MRI, ultrasound and 11C-choline PET/CT. Such methods can be used to eliminate the need for invasive methods such as mapping biopsies.
详细描述
- Purpose
To test the efficacy, acute side effects and long term safety of Focal Therapy in Prostate Cancer, as compared to conventional radical lose dose radiation prostate brachytherapy (LDR-PB). 2. Hypothesis
We hypothesize that, in an appropriately selected group of early-stage, favourable risk prostate cancer patients, focal LDR-PB will lead to fewer acute side effects, long term complications resulting is a better quality of life than radical LDR-PB.
We also hypothesize that multi-modal, multi-parametric imaging will enable monitoring of the results of focal therapy with an accuracy that is high enough to eventually replace repeated (and invasive) mapping biopsies. 3. Justification
The imaging study we propose is unique in terms of its multi-modality, multi-parametric approach. Local disease will be monitored by a very complete set of multi-parametric MR, ultrasound and PET-CT imaging. Potential spread of the disease may be captured by abdominal and whole-body PET-CT. Comparison with biopsies will be more accurate than in other studies because biopsy location will be accurately provided by the trans-perineal three-dimensional template-guided pathological mapping biopsy (TTMB), in contrast to Post-radical prostatectomy (RP) studies that use axial whole mount slices which suffer from a significant change in prostate physical shape and unpredictable deformation due to fixation, making an accurate registration of pathology and imaging difficult.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Must be 18 years of age or older
- •Must be able to give informed consent
- •Histologic diagnosis of prostate adenocarcinoma made on transrectal guided prostate biopsy with no fewer than 6 cores taken
- •The prostate cancer is considered suitable for a strategy of active surveillance as well as conventional radical treatment.
- •No more than 2 cores from one lobe containing cancer
- •Gleason sum no greater than 3+4 =7 in any one core
- •Clinical T stage no higher than T2a
- •Serum prostate-specific antigen (PSA) no higher than 10 ng/mL
- •No previous radiation therapy to the pelvis
- •No prior history of malignancy except non-melanoma skin cancer
- •Must be suitable for general or spinal anesthesia
- •Must not be on coumadin or other anticoagulants
- •Must be suitable for multi-parametric MRI scan (excluded are those with significant renal impairment that would preclude the use of contrast agents and may exclude some patients with cardiac pacemaker, wires, or defibrillator; artificial heart valve; brain aneurysm clip; electrical stimulator for nerves or bones; ear or eye implant; implanted drug infusion pump; coil, catheter, or filter in any blood vessel. Some men with metallic prostheses; shrapnel, bullets, or other metal fragments retained in the body may be excluded as well.
排除标准
- •They are unable to participate in an MRI scan.
- •They are unable to undergo general or spinal anesthesia.
- •They are on anticoagulation therapy (blood thinners).
- •They have had previous radiotherapy to the pelvis.
结局指标
主要结局
Constitute Disease Criteria and Appropriate Treatment Plans
时间窗: Approximately 4 years; upon study completion
To develop criteria for what constitutes focal disease and treatment plans appropriate for focal LDRB.
次要结局
- Quality of Life(Approximately 4 years; upon study completion)