A Pilot Study of High Dose Rate Brachytherapy as Definitive Management for Intermediate Risk Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Number of Patients With an Acceptable Level of Severe Toxicity as Defined at < Grade 3 CTC Toxicity
研究概览
简要总结
RATIONALE: Internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells.
PURPOSE: This clinical trial is studying the side effects and how well internal radiation therapy works in treating patients with prostate cancer.
详细描述
OBJECTIVES:
Primary
- To assess the feasibility of high-dose rate (HDR) brachytherapy (without the use of external-beam radiotherapy) as definitive treatment for patients with intermediate-risk prostate cancer.
- To assess acceptable toxicity, defined as treatment related toxicity (urinary and rectal), no worse than that seen by patients treated with conventional therapy (grade 3 urinary toxicity < 10% and grade 3 rectal toxicity < 10%).
Secondary
- To achieve adequate dosimetric coverage of the prostate comparable to current standards.
- To assess the effect of treatment on sexual function.
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 120 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Inclusion criteria:
- •Intermediate-risk adenocarcinoma of the prostate, defined by 1of the following criteria:
- •PSA 10-20 ng/mL
- •Gleason score ≥ 7
- •Stage ≥ T2b AND < T3
- •Less than 20% risk of seminal vesicle involvement or lymph node involved based upon the Kattan nomogram (pre-treatment risk with IMRT)
- •Prostate size < 60 cc by MRI or CT imaging
- •International Prostate Symptom Score Index ≤ 15
排除标准
- •Evidence of definitive extracapsular extension/seminal vesicle invasion or pelvic adenopathy by MRI (endorectal coil) and DRE (digital rectal examination)
- •Suspected extracapsular disease will not be considered an exclusion criteria
- •PSA > 20 ng/mL
- •Presence of distant metastases
- •PATIENT CHARACTERISTICS:
- •WBC ≥ 3,500/mm³
- •Platelet count ≥ 75,000/mm³
- •Hemoglobin ≥ 10 g/dL
- •Creatinine ≤ 1.5 mg/dL
- •Liver function tests ≤ 1.5 times normal
- •INR ≤ 2.5
- •Able to complete quality of life questionnaires
- •Able to give informed consent
- •No active perineal infections
- •No history of urethral stricture
- •No prior history of pelvic malignancy
- •No prior history of lymphoma disease, ulcerative colitis, or anal fissures
- •No contraindications to general anesthesia
- •No pacemaker
- •PRIOR CONCURRENT THERAPY:
- •No prior transurethral resection of the prostate
- •No prior pelvic radiotherapy
- •No prior treatment for prostate cancer except for hormone therapy
研究组 & 干预措施
HDR Brachytherapy
9.5 Gy HDR Brachytherapy for 4 fractions given over 2 days
干预措施: questionnaire administration (Other)
HDR Brachytherapy
9.5 Gy HDR Brachytherapy for 4 fractions given over 2 days
干预措施: quality-of-life assessment (Procedure)
HDR Brachytherapy
9.5 Gy HDR Brachytherapy for 4 fractions given over 2 days
干预措施: brachytherapy (Radiation)
结局指标
主要结局
Number of Patients With an Acceptable Level of Severe Toxicity as Defined at < Grade 3 CTC Toxicity
时间窗: At scheduled 3 month intervals for one year
Feasibility will be defined as an acceptable level of severe toxicity (both acute and late effects), and adequate dosimetric coverage. Severe toxicity will be defined as \> or = grade 3 NCI CTC toxicity
Number of Patients With an Acceptable Level of Treatment Related Urinary and Rectal Toxicity as Defined at < Grade 3 CTC Toxicity
时间窗: Within 90 days of treatment (early toxicities) or after 90 days (late toxicities)
urinary and rectal toxicity-see the adverse event tables
次要结局
未报告次要终点