NCT00583492已完成2 期
A Randomized, Controlled Trial of Replication-Competent Adenovirus-Mediated Suicide Gene Therapy in Combination With IMRT Versus IMRT Alone for the Treatment of Newly-Diagnosed Prostate Cancer With an Intermediate Risk Profile
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Freedom From Biochemical/Clinical Failure (FFF)
研究概览
简要总结
This is a randomized, controlled trial that will test the hypothesis that replication-competent adenovirus-mediated suicide gene therapy in combination with 80 Gy intensity modulated radiotherapy (IRMT)will improve freedom from failure (FFF) relative to 80 Gy IMRT alone in patients with newly-diagnosed prostate cancer with an intermediate-risk profile.
详细描述
OBJECTIVES
This is a randomized, controlled trial that will test the hypothesis that replication-competent adenovirus-mediated suicide gene therapy in combination with 80 Gy intensity modulated radiotherapy (IRMT)will improve freedom from failure (FFF) relative to 80 Gy IMRT alone in patients with newly-diagnosed prostate cancer with an intermediate-risk profile.
The trial contains two treatment arms:
Arm 1- Gene Therapy + IMRT Arm 2- IMRT
The study will be stratified by clinical site and pre-treatment risk factors (e.g., % positive biopsy cores, Gleason score.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Men with histologically-confirmed adenocarcinoma of the prostate within 180 days prior to registration. To be eligible, the subjects must have one of the following conditions:
- •Stage T1 or T2, Gleason Score 7, PSA <= 20 ng/mL, Any number positive biopsy cores
- •Stage T1 or T2, Gleason Score 5 or 6, PSA >=10 ng/mL and <20 ng/mL, Any number positive biopsy cores
- •Stage T1 or T2, Gleason Score 5 or 6, PSA <10 ng/mL and >=50% positive biopsy cores
- •Negative lymph nodes as established by imaging, nodal sampling, or dissection within 90 days prior to registration.
- •No evidence of metastatic disease as evaluated by bone scan and CT scan of the abdomen and pelvis within 90 days prior to registration
- •Karnofsky performance status >=70
- •Subjects must have adequate baseline organ function, as assessed by the following laboratory values, within 30 days before initiating the study
- •Adequate renal function with serum creatinine <=1.5 mg/dL or creatinine clearance >=45 mL/min/m
- •Platelet count > 100,000/μL.
- •Absolute neutrophil count > 1,000/μL.
- •Hemoglobin > 10.0 g/dL.
- •Normal partial thromboplastin time (PTT) and prothrombin (PT).
- •Bilirubin < 1.5 mg/dL; SGOT and SGPT < 2.5 times upper limit of normal (ULN).
- •Men of child-producing potential must be willing to consent to use effective contraception while on treatment and for at least 3 months afterwards.
- •Subjects must possess the ability to give informed consent and express a willingness to meet all of the expected requirements of the protocol for the duration of the study.
排除标准
- •Subjects with the following conditions will be excluded from the study:
- •Stage >= T
- •Prostate specific antigen (PSA) > 20 ng/mL.
- •Gleason score >=
- •Prostate volume >120cc.
- •Pathologically positive lymph nodes or nodes > 1.5 cm on imaging. Note: nodes > 1.5 cm but biopsy negative are allowed.
- •Evidence of M1 metastatic disease.
- •Prior invasive malignancy except for non-melanoma skin cancer within 5 years of enrollment.
- •Prognosis for survival of < 5 years.
- •Prior radical prostatectomy, cryosurgery for prostate cancer, or bilateral orchiectomy for any reason.
- •Prior radiotherapy, including brachytherapy, to the region of the study cancer that would result in overlap of radiation fields.
- •Prior or planned androgen suppression therapy or prior systemic chemotherapy for the study cancer. Note that prior chemotherapy for a different cancer is allowed; however, patients must be >2 years post-completion of chemotherapy at time of registration. Patients on Proscar therapy must stop to be eligible.
- •Severe, active co-morbidity defined as:
- •Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months.
- •Transmural myocardial infarction within the last 6 months.
- •Acute infection. Acute infection is defined by any viral, bacterial, or fungal infection that requires specific therapy within 72 hours of initiation of the study therapy.
- •Positive serological test for HIV at baseline.
- •Previous history of liver disease including hepatitis.
- •Immunosuppressive therapy including systemic corticosteroids. Use of inhaled and topical corticosteroids is permitted.
- •Impaired immunity or susceptibility to serious viral infections.
- •Allergy to any product used in the protocol. (If the subject has an allergy to Ciprofloxacin, another antibiotic can be substituted at the discretion of the treating physician.
- •Serious medical or psychiatric illness or concomitant medication, which, in the judgment of the principal investigator, might interfere with the subject's ability to respond to or tolerate the treatment or complete the trial.
研究组 & 干预措施
IMRT Alone
Active Comparator
IMRT: 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy
干预措施: IMRT (Radiation)
Ad5-yCD/mutTKSR39rep-ADP + IMRT
Experimental
Gene Therapy + IMRT
干预措施: Ad5-yCD/mutTKSR39rep-ADP (Biological)
结局指标
主要结局
Freedom From Biochemical/Clinical Failure (FFF)
时间窗: 5 years
Biochemical/Clinical Failure was defined as PSA nadir plus 2 ng/mL
次要结局
- Acute >= Grade 3 Treatment-related Toxicity(90 days)
- Positive Prostate Biopsy at 2 Years(2 years)
- Freedom From Distant Metastases(10 years)
- Disease-specific Survival(10 years)
- Decrease in Quality of Life(3 years)
研究者
Benjamin Movsas, M.D.
Chairman, Department of Radiation Oncology
Henry Ford Health System
研究点 (2)
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