NCT00450411已完成2 期
A Prospective Phase II Trial of Transperineal Ultrasound-Guided Brachytherapy for Locally Recurrent Prostate Adenocarcinoma Following External Beam Radiotherapy
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 34
- 主要终点
- Number of Patients With Late Treatment-related Gastrointestinal (GI) and Genitourinary (GU) Adverse Events (AE)
研究概览
简要总结
RATIONALE: Implant radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells.
PURPOSE: This phase II trial is studying the side effects and how well ultrasound-guided implant radiation therapy works in treating patients with locally recurrent prostate cancer previously treated with external-beam radiation therapy.
详细描述
OBJECTIVES:
Primary
- Determine the late treatment-related gastrointestinal (GI) and genitourinary (GU) adverse events in patients with locally recurrent adenocarcinoma of the prostate previously treated with external-beam radiotherapy who are currently receiving transperineal ultrasound-guided iodine I 125 or palladium Pd 103 brachytherapy.
Secondary
- Determine the acute treatment-related GI and GU adverse events in patients treated with this regimen.
- Determine the overall survival of patients treated with this regimen.
- Determine the disease-free survival of patients treated with this regimen.
- Determine the disease-specific survival of patients treated with this regimen.
- Determine clinical patterns of tumor recurrence (time to local tumor progression or distant failure) in patients treated with this regimen.
- Determine the time to biochemical failure in patients treated with this regimen.
- Determine the post-brachytherapy dosimetric coverage in patients treated with this regimen.
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
- •Biopsy-documented locally recurrent prostatic adenocarcinoma > 30 months after the completion of EBRT, biopsied ≤ 180 days prior to registration and confirmed by central pathology review
- •Disease-related characteristics at initial diagnosis (i.e., prior to EBRT) that fit the following criteria: Stages T1-T2c, Gleason scores 2-7, and PSA ≤ 20 ng/mL
- •Staging, performed within 8 weeks prior to registration:
- •3.1 History/physical examination (to include at a minimum digital rectal examination of the prostate and examination of the skeletal system and abdomen)
- •3.2 Negative lymph nodes by imaging (pelvic ± abdominal CT or MR), or by nodal dissection (laparoscopy or laparotomy)
- •3.3 No evidence of bone metastases (M0) on bone scan
- •Zubrod Performance Scale 0-1
- •American Urological Association Symptom Index Score (AUA BPH) < 15 (Note: The use of alpha blockers is permitted when evaluating lower urinary tract symptoms, i.e., the AUA score with the patient on alpha blockers is acceptable)
- •Baseline serum prostate-specific antigen (PSA) value < 10 ng/mL performed with an FDA-approved assay (e.g., Abbott, Hybritech) within 8 weeks prior to registration. PSA should not be performed within 10 days of a prior prostate biopsy, and if the patient has been started on hormonal therapy, the PSA should be performed within 8 weeks prior to the commencement of hormonal therapy.
- •Prostate volume as measured by transrectal ultrasound (TRUS) ≤ 45 cc or pubic arch interference ruled out
- •The patient must be suitable for spinal or general anesthesia
- •The patient must sign a study-specific informed consent form before study entry
排除标准
- •Prior invasive (except non-melanoma skin cancer) or hematological (e.g., acute leukemia, aggressive lymphoma, myeloma) malignancy unless disease-free for a minimum of 3 years. Previous diagnosis of low-grade lymphoma or chronic lymphocytic leukemia is allowed.
- •Prior EBRT to the prostate such that the minimum dose to the prostate exceeded 78 Gy (2 Gy fractions) or 79.8 Gy (1.9 Gy fractions) or 81 Gy (1.8 Gy fractions)
- •Baseline gastrointestinal (GI) or genitourinary (GU) toxicity (for any reason) grade ≥ 2 as defined in Common Terminology Criteria for Adverse Events (CTCAE) version 3.
- •Severe, active co-morbidity, defined as follows:
- •4.1 Unstable angina and/or decompensated congestive heart failure
- •4.2 Myocardial infarction within the last 6 months
- •4.3 Bacterial or fungal infection requiring intravenous antibiotics at the time of registration
- •4.4 Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
- •4.5 Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
- •4.6 Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements may also exclude immuno-compromised patients.
- •Clinical and/or radiologic evidence of extraprostatic disease at initial diagnosis (i.e., prior to EBRT) or at time of local recurrence (i.e., prior to study registration)
- •° 5.1 Histologic or radiologic evidence of tumor involvement of regional lymph nodes (N1) or the presence of metastatic disease (M1)
- •Any of the following prior therapies:
- •Transurethral resection of the prostate (TURP)
- •Radionuclide (permanent or temporary implantation) prostate brachytherapy
- •Prostatectomy or prostatic cryosurgery
- •High-intensity focused ultrasound (HIFU)
- •Bilateral orchiectomy
- •Chemotherapy for prostatic carcinoma
- •NOTE 1: Androgen suppression therapy is permissible provided that the luteinizing hormone-releasing hormone (LHRH) agonist was started at least 2 months and no more than 6 months before registration.
- •NOTE 2: Any combination of neoadjuvant, concurrent, or adjuvant androgen suppression therapy at the time of initial external radiotherapy is permissible provided the total duration was ≤ 8 months. If > 8 months, evidence of a normal serum testosterone must be documented.
结局指标
主要结局
Number of Patients With Late Treatment-related Gastrointestinal (GI) and Genitourinary (GU) Adverse Events (AE)
时间窗: Between 271 days and 730 days from date of implantation
Adverse events are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. For the purposes of this study, late treatment-related adverse events were evaluated between 271 days and 730 days from the implant.
次要结局
- Percentage of Participants With Distant Failure at 5 Years(From registration to 5 years)
- Number of Patients With Acute Treatment-related GI and GU Adverse Events(From date of implantation to 270 days)
- Percentage of Participants Alive at 5 Years (Overall Survival)(From registration to 5 years)
- Percentage of Participants With Prostate Cancer Death at 5 Years (Disease-specific Survival)(From registration to 5 years)
- Percentage of Participants Alive Without Disease (Disease-free Survival)(From registration to 5 years)
- Percentage of Participants With Local Failure at 5 Years(From registration to 5 years)
- Percentage of Participants With Biochemical Failure at 4 Years(From registration to 5 years)
研究者
研究点 (34)
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