NCT01255891已完成2 期
A Phase II Study of Adjuvant Androgen Suppression Plus Radiation Therapy for High-Risk Localized Adenocarcinoma of the Prostate
Dr. Tamim Niazi4 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2010年1月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 4
- 主要终点
- to determine the rate of local and distance failure at 5 years
研究概览
简要总结
To evaluate the efficacy of LHRH agonist with adjuvant pelvic radiation therapy in post radical prostatectomy patients with high risk pathological features for failure. To determine the freedom from biochemical (maintenance of a PSA less than nadir + 2 ng/ml) and clinical progression rate at 5 years.
详细描述
Same as brief Summary
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Adenocarcinoma of the prostate treated primarily with radical prostatectomy, pathologically proven to be lymph node negative by pelvic lymphadenectomy (N0) or lymph node status pathologically unknown (undissected pelvic lymph nodes [Nx]), i.e. lymph node dissection is not required;
- •Any type of radical prostatectomy will be permitted, including retropubic, perineal laparoscopic or robotically assisted. If performed, the number of lymph nodes removed per side of the pelvis and the extent of the pelvic lymph node dissection (obturator vs. extended lymph node dissection) should be noted. There is no time limit for the date of radical prostatectomy.
- •A post-radical prostatectomy entry PSA of > 0 and < 1 ng/ml at least 6 weeks after prostatectomy and within 30 days of registration.
- •One of the following pathologic/chemical classifications:
- •T3N0/Nx disease with or without positive surgical margin; or;
- •Gleason score of 8 or more;
- •Pre prostatectomy PSA > 20 ng/ml
- •No distant metastases, based upon the following minimum diagnostic workup:
- •History/physical examination (including digital rectal exam) within 8 wks prior to registration;
- •A CT scan or MRI of the abdomen and pelvis within 120 days prior to registration;
- •Bone scan within 120 days prior to registration; if the bone scan is suspicious, a plain x-ray and/or MRI must be obtained to rule out metastasis.
- •Adequate bone marrow function, within 90 days prior to registration, defined as follows:
- •Platelets ≥ 100,000 cells/mm3 based upon CBC;
- •Hemoglobin ≥ 10.0 g/dl based upon CBC
- •AST or ALT < 2 x the upper limit of normal within 90 days prior to registration;
- •Patients must sign a study-specific informed consent prior to study entry.
排除标准
- •A palpable prostatic fossa abnormality/mass suggestive of recurrence, unless shown by biopsy under ultrasound guidance not to contain cancer;
- •N1 patients are ineligible, as are those with pelvic lymph node enlargement ≥ 1.5 cm in greatest dimension by CT scan or MRI of the pelvis, unless the enlarged lymph node is sampled and is negative;
- •Androgen deprivation therapy started prior to prostatectomy for > 6 months duration;
- •Androgen deprivation therapy started after prostatectomy and prior to registration;
- •Prior pelvic radiotherapy;
- •Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 5 years (for example, carcinoma in situ of the oral cavity is permissible);
- •Severe, active co-morbidity, defined as follows:
- •History of inflammatory bowel disease;
- •History of hepatitis B or C; Blood tests are not required to determine if the patient has had hepatitis B or C, unless the patient reports a history of hepatitis.
- •Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months;
- •Transmural myocardial infarction within the last 6 months
- •Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration;
- •Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration;
- •Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; AST or ALT are required; note, however, that laboratory tests for coagulation parameters are not required for entry into this protocol.
- •Prior allergic reaction to the study drug(s) involved in this protocol.
结局指标
主要结局
to determine the rate of local and distance failure at 5 years
时间窗: 5 years
次要结局
未报告次要终点
研究者
Dr. Tamim Niazi
Principal Investigator
Sir Mortimer B. Davis - Jewish General Hospital
研究点 (4)
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