Pilot Evaluation of High Dose-Rate Brachytherapy ± Image-Guided Intensity Modulated Hypofractionated External Radiotherapy for Localized Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Treatment Tolerance (Genitourinary [GU] or Gastrointestinal [GI] Adverse Events)
研究概览
简要总结
RATIONALE: Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.
PURPOSE: This phase II trial is studying the side effects of internal radiation therapy when given with or without external-beam radiation therapy and to see how well it works in treating patients with localized prostate cancer.
详细描述
OBJECTIVES:
Primary
- Evaluate the tolerability of 2 radiotherapeutic regimens (high dose-rate brachytherapy [HDR] with or without image-guided intensity-modulated hypofractionated external beam radiotherapy [EBRT]), as measured by the Common Terminology Criteria for Adverse Events (CTCAE v3.0), in patients with localized prostate cancer.
Secondary
- Identify any associations between dose-volume parameters for organs at risk and the rate and severity of genitourinary or gastrointestinal adverse events.
- Evaluate patient preference with regard to selection of a second treatment (a second HDR brachytherapy session or an EBRT session).
- Evaluate patient-reported health-related quality of life (HRQOL) as measured by validated HRQOL instruments for 5 years.
- Describe the probability of freedom from biochemical and clinical failure.
- Describe the probability of freedom from salvage androgen suppression.
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:
- •Histologically confirmed adenocarcinoma of the prostate, meeting one of the following criteria:
- •Low-risk disease (T1-T2a, Gleason score ≤ 6, and PSA < 10 ng/mL)
- •Low intermediate-risk disease (T1-T2c, Gleason score ≤ 6, and PSA < 20 ng/mL OR T1-T2a, Gleason score 7, and PSA < 10 ng/mL)
- •No known nodal (N0 or NX) or distant (M0 or MX) metastases
- •No pubic arch interference, as defined by either of the following:
- •Maximum transrectal ultrasound-determined anterior-posterior (z-axis) dimension < 4.3 cm
- •No more than 25% prostate volume blocked (by pubic arch) on CT scan simulation at A10°I beam's eye view
- •Prostate planimetry volume ≤ 60 cc as determined by step-section transrectal ultrasound
- •American Urological Association voiding symptom index ≤ 12
- •Peak uroflow rate (Q_max) ≥ 12 cc/second
- •Post-void ultrasound bladder residual volume ≤ 100 cc
- •PATIENT CHARACTERISTICS:
- •Zubrod performance status 0-1
- •Life expectancy ≥ 5 years
- •WBC > 2,000/μL
- •Platelet count > 100,000/μL
- •PT < 1.5 times upper limit of normal
- •No diabetes mellitus associated with vascular ulcers or wound-healing problems
- •No blood dyscrasias
- •No inflammatory bowel disease
- •No connective tissue disorder
- •No other prior or concurrent invasive malignancy (except nonmelanoma skin cancer) or lymphomatous or hematological malignancy (except chronic lymphocytic leukemia/lymphoma) unless patient has been continually disease-free for ≥ 5 years
- •No medical or psychiatric condition that would preclude giving informed consent or complying with study treatment
- •Able to undergo anesthesia
- •PRIOR CONCURRENT THERAPY:
- •No prior transurethral resection of the prostate
- •No prior prostatic cryoablation or high-intensity focused ultrasound
- •No prior prostatectomy
- •No prior prostatic enucleation
- •No prior pelvic external beam radiotherapy
- •No prior radionuclide prostate brachytherapy
- •No prior hemi- or total hip arthroplasty
- •Neoadjuvant androgen suppression therapy allowed provided it was initiated 2-6 months prior to study entry and its total duration is ≤ 6 months
- •No concurrent anticoagulation therapy, including heparin or coumadin
排除标准
- 未提供
研究组 & 干预措施
Intervention Group
Protocol treatment consists of either two high dose-rate (HDR) brachytherapy implantation sessions or one HDR brachytherapy session followed by external beam radiotherapy (EBRT). Each HDR session consists of two 9.5Gy fractions. After the first HDR session of two fractions, patients express a preference for: (1) a second HDR brachytherapy implantation session, or (2) EBRT. The second HDR session or EBRT will begin 2-4 weeks after the first HDR brachytherapy session.
干预措施: brachytherapy (Radiation)
Intervention Group
Protocol treatment consists of either two high dose-rate (HDR) brachytherapy implantation sessions or one HDR brachytherapy session followed by external beam radiotherapy (EBRT). Each HDR session consists of two 9.5Gy fractions. After the first HDR session of two fractions, patients express a preference for: (1) a second HDR brachytherapy implantation session, or (2) EBRT. The second HDR session or EBRT will begin 2-4 weeks after the first HDR brachytherapy session.
干预措施: hypofractionated radiation therapy (Radiation)
Intervention Group
Protocol treatment consists of either two high dose-rate (HDR) brachytherapy implantation sessions or one HDR brachytherapy session followed by external beam radiotherapy (EBRT). Each HDR session consists of two 9.5Gy fractions. After the first HDR session of two fractions, patients express a preference for: (1) a second HDR brachytherapy implantation session, or (2) EBRT. The second HDR session or EBRT will begin 2-4 weeks after the first HDR brachytherapy session.
干预措施: image-guided radiation therapy (Radiation)
Intervention Group
Protocol treatment consists of either two high dose-rate (HDR) brachytherapy implantation sessions or one HDR brachytherapy session followed by external beam radiotherapy (EBRT). Each HDR session consists of two 9.5Gy fractions. After the first HDR session of two fractions, patients express a preference for: (1) a second HDR brachytherapy implantation session, or (2) EBRT. The second HDR session or EBRT will begin 2-4 weeks after the first HDR brachytherapy session.
干预措施: intensity-modulated radiation therapy (Radiation)
结局指标
主要结局
Treatment Tolerance (Genitourinary [GU] or Gastrointestinal [GI] Adverse Events)
时间窗: From baseline to 3 years after registration
Separately evaluate the tolerance of 2 radiotherapeutic regimens (HDR alone and HDR followed by hypofractionated EBRT) using the Common Terminology Criteria for Adverse Events (CTCAE v3.0). The specific adverse events (AEs) are early (i.e., within 270 days of treatment completion) grade \>3 genitourinary (GU) and/or gastrointestinal (GI) AEs, late grade 2 GU and GI AEs, and late grade ≥3 GU and GI AEs.
次要结局
- Freedom From Salvage Androgen Suppression Treatment(From baseline to 5 years after registration)
- Association Between Dose-volume Limitations for Organs at Risk and Rate and Severity of GU or GI Adverse Events(From baseline to 5 years after registration)
- Freedom From Biochemical and Clinical Failure(From baseline to 5 years after registration)
- Patient Preference for a Second Treatment (a Second High Dose-rate Brachytherapy Session or an External Beam Radiotherapy Session)(From baseline until the end of the first treatment)
- Changes in Health-related Quality of Life Scores(From baseline to 5 years after registration)