Pilot Study of Focal Salvage HDR Prostate Brachytherapy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Incidence of acute urinary and rectal toxicities
研究概览
简要总结
Radiation therapy is considered a standard treatment option for the management of localized prostate cancer. Among the 20-30% who recur, a proportion of them will present with an isolated local recurrence, meaning no distant metastases. If left untreated, it may serve as a source for subsequent metastases. Salvage options available for isolated local recurrence include; temporary or permanent implantation of radioactive seeds into the prostate, complete removal of the prostate gland, use of low temperatures to treat the disease, and high frequency ultrasound to treat the disease. There are risks of complications associated with all these treatments, and there is presently no consensus as to which treatment is the best. Therefore, the aim of this pilot study is to look at the feasibility and toxicities of focal treatment of the prostate using temporary implantation of radioactive seeds into the prostate which the investigators hope will be less since the entire prostate is not treated.
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
- •Biopsy-confirmed locally recurrent prostate adenocarcinoma > 30months after the completion of XRT, SBRT, LDR or HDR brachytherapy boost with XRT, or LDR or HDR brachytherapy as monotherapy by a stereotactic transperineal biopsy
- •Staging T2-weighted, DWI and DCE-MRI that demonstrates solitary recurrence confined to prostate, and correlates with stereotactic transperineal biopsy
- •Staging CT or MRI (abdomen and pelvis) and bone scan are negative for metastases
- •American Urological Association Symptom Index Score (ie. IPSS) < 15
- •Baseline (post-XRT) serum PSA < 10 ng/mL
- •Prostate volume as measured by transrectal ultrasound (TRUS) < 50cc
- •ECOG performance status 0-1
排除标准
- •Any of the following prior therapies: transurethral resection of the prostate (TURP), radionuclide (permanent or temporary implantation) prostate brachytherapy, prostatectomy or prostatic cryosurgery, HIFU (high-intensity focused ultrasound), bilateral orchiectomy, chemotherapy for prostatic carcinoma
- •Evidence of castrate resistance (defined as PSA > 3 ng/mL while testosterone is < 1.7 nmol/L). Patients could have been on combined androgen blockade with initial radiotherapy but are excluded if this was started due to PSA progression.
结局指标
主要结局
Incidence of acute urinary and rectal toxicities
时间窗: Acute period (<6 months)
Common Terminology Criteria for Adverse Events (CTCAE) v4.0
次要结局
- Biochemical (ie. prostate specific antigen) disease free survival(5 years)
- Quality of Life (QoL)(5 years)
- Incidence of late urinary and rectal toxicities(Late period (>6 months))
- Acute and late urinary toxicities(5 years)
研究者
Dr. Hans Chung
Dr. Hans Chung
Sunnybrook Health Sciences Centre