A Phase I and II Study of Stereotactic Body Radiation Therapy (SBRT) for Low and Intermediate Risk Prostate Cancer (SBRT Prostate)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 94
- 试验地点
- 5
- 主要终点
- No. of Late Severe GU Toxicity (for Phase 2 Only)
研究概览
简要总结
RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue.
PURPOSE: This phase I/II trial is studying the side effects and best dose of stereotactic body radiation therapy and to see how well it works in treating patients with prostate cancer.
详细描述
OBJECTIVES:
Primary
- To escalate the dose of stereotactic body radiotherapy (SBRT) to a tumoricidal dose without exceeding the maximum tolerated dose in patients with organ-confined prostate cancer. (Phase I)
- To determine the late, severe grade 3-5 genitourinary and gastrointestinal toxicity occurring between 270-540 days (i.e., 9-18 months) from the start of the protocol treatment as assessed by CTCAE v3.0. (Phase II)
Secondary
- To determine the dose-limiting toxicity of SBRT in these patients. (Phase I)
- To determine the 2-year biochemical (PSA) control (freedom from PSA failure), disease-free and overall survival, local control, freedom from distant metastases, and the incidence of high-grade adverse events of any type in patients treated with this therapy in order to determine if the therapy is promising enough for further clinical investigation. (Phase II)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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:
- •Histologically confirmed adenocarcinoma of the prostate
- •Stage T1a, T1b, T1c disease
- •Stage T2a or T2b
- •No direct evidence of regional or distant metastases
- •No T2c, T3, or T4 tumors
- •Gleason score ≤ 7
- •Must meet the following criteria:
- •Prostate-specific antigen (PSA) ≤ 20 ng/mL prior to starting hormonal therapy (if given) for patients with a Gleason score of 2-6
- •PSA ≤ 15 ng/mL prior to starting hormonal therapy (if given) for patients with a Gleason score of 7
- •Risk of pelvic lymph node involvement < 20% according to Roach formula
- •Ultrasound-based volume estimation of the prostate gland ≤ 60 g
- •PATIENT CHARACTERISTICS:
- •Zubrod performance status 0-2
- •Fertile patients must use effective contraception
- •No prior invasive malignancy, except for nonmelanoma skin cancer, unless disease-free for a minimum of 3 years (e.g., carcinoma in situ of the breast, oral cavity, or cervix are allowed)
- •No significant urinary obstructive symptoms
- •American Urological Association (AUA) score of ≤ 15 (alpha blockers allowed)
- •No history of inflammatory colitis (including Crohn disease and ulcerative colitis)
- •No history of significant psychiatric illness
- •No severe, active comorbidity including any of the following:
- •Unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months
- •Transmural myocardial infarction within the past 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 within 30 days prior to registration
- •Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
- •Laboratory tests for liver function and coagulation parameters are not required for entry into this protocol
- •AIDS (based on current CDC definition) or other immunocompromising condition
- •HIV testing is not required for entry into this protocol
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •More than 9 months since prior hormonal therapy as neoadjuvant therapy or to downsize the prostate gland
- •No prior pelvic radiotherapy
- •No prior chemotherapy or surgery for prostate cancer
- •No prior transurethral resection of the prostate (TURP) or cryotherapy to the prostate
- •No plans for other concurrent post-treatment, adjuvant, antineoplastic therapy including surgery, cryotherapy, conventionally fractionated radiotherapy, hormonal therapy, or chemotherapy as part of the treatment for prostate cancer
排除标准
- 未提供
研究组 & 干预措施
Phase 1: Stereotactic Body Radiation Therapy (SBRT) 45 Gy
The Phase 1 portion of the study will have a 3+3 design. The dose of SBRT is escalated - 45 Gy
干预措施: stereotactic body radiation therapy (SBRT)- 45 Gy (Radiation)
Phase 2: Stereotactic Body Radiation Therapy (SBRT)- 50 Gy
The dose of SBRT is escalated - 50 Gy in Phase 2
干预措施: stereotactic body radiation therapy (SBRT) - 50 Gy (Phase 2) (Radiation)
Phase 1: Stereotactic Body Radiation Therapy (SBRT)- 47.5 Gy
The Phase 1 portion of the study will have a 3+3 design. The dose of SBRT is escalated- 47.5 Gy
干预措施: stereotactic body radiation therapy (SBRT) - 47.5 Gy (Radiation)
Phase 1: Stereotactic Body Radiation Therapy (SBRT)- 50 Gy
The Phase 1 portion of the study will have a 3+3 design. The dose of SBRT is escalated- 50 Gy
干预措施: stereotactic body radiation therapy (SBRT) - 50 Gy (Phase 1) (Radiation)
结局指标
主要结局
No. of Late Severe GU Toxicity (for Phase 2 Only)
时间窗: 18 months
To determine late severe GU toxicity defined as grade 3-5 occurring between 279-540 days (i.e., 9-18 months) from the start of protocol treatment. Toxicity was defined using the National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) v.3.0. CTCAE uses a range of grades from 1 to 5; 1 - Mild 2 - Moderate 3 - Severe 4 - Life-threatening 5 - Death.
Number of Participants With Dose Limiting Toxicity (Phase 1 Only)
时间窗: 90 days after start of treatment
Dose-limiting toxicity (DLT) was defined as grade 3 to 5 GI, genito urinary, sexual, or neurologic toxicity attributed to therapy occurring within 90 days of registration using Common Terminology Criteria of Adverse Events(version 3)
No. of Late Severe GI Toxicity (for Phase 2 Only)
时间窗: 18 months
To determine late severe GI toxicity defined as grade 3-5 occurring between 279-540 days (i.e., 9-18 months) from the start of protocol treatment. Toxicity was defined using the National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) v.3.0. CTCAE uses a range of grades from 1 to 5; 1 - Mild 2 - Moderate 3 - Severe 4 - Life-threatening 5 - Death.
次要结局
- GU Toxicity (Only Phase 2)(9 months from start of treatment)
- GI Toxicity(9 months from start of treatment)
- Non-GU Toxicity(60 months)
- Non-GI Toxicity(60 months)
- Freedom From Biochemical Failure(36 months)
- Overall Survival(60 months)
- Disease Specific Survival(60 months)
- Clinical Progression Including Local/Regional and Distant Relapse(60 months)
研究者
Robert Timmerman
Professor of Medicine
University of Texas Southwestern Medical Center