Extremely Hypofractionated Intensity Modulated Stereotactic Body Radiotherapy for Adjuvant or Salvage Treatment for Rising PSA After Radical Prostatectomy (EXCALIBUR)
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 165
- 试验地点
- 2
- 主要终点
- Change of Expanded Prostate Cancer Index (EPIC) score for the gastrointestinal domain
研究概览
简要总结
This phase II trial investigates the effect of extremely hypofractionated intensity modulated stereotactic body radiotherapy in treating patients with prostate cancer that has rising prostate specific antigen (PSA) after radical prostatectomy. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects.
详细描述
PRIMARY OBJECTIVES:
I. To determine the two-year change in patient-reported gastrointestinal (GI) symptoms based on the Expanded Prostate Cancer Index (EPIC) instrument following stereotactic body radiotherapy (SBRT) to the prostate bed and/or pelvic lymph nodes, with a comparison to historical control data for more prolonged radiation regimens.
II. To determine the two-year change in patient-reported urinary (GU) symptoms based on the EPIC instrument following stereotactic body radiotherapy (SBRT) to the prostate bed and/or pelvic lymph nodes, with a comparison to historical control data for more prolonged radiation regimens.
SECONDARY OBJECTIVES:
I. To quantify patient-reported GI symptoms using the EPIC instrument at 3 months, 6 months, 1 and 5 years.
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 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •History of histologically confirmed, clinical localized adenocarcinoma of the prostate treated with radical prostatectomy with definitive intent
- •Presence of any ONE of the following:
- •Adverse pathologic features at the time of prostatectomy (positive surgical margin, pathologic T-stage 3-4 disease, pathologic Gleason score 8-10 disease, OR presence of tertiary Gleason grade 5 disease)
- •Documentation of rising prostate-specific antigen on at least two consecutive draws, with the magnitude of prostate-specific antigen exceeding 0.03 ng/mL
- •Intermediate- or high-risk Decipher genomic classifier score
- •Identification of prostate cancer in >= 1 lymph node at the time of prostatectomy (pN+ disease)
- •CT scan and MRI of the pelvis within 120 days prior to enrollment [note: (a) if patient has medical contraindication to MRI, an exemption will be granted and enrollment can proceed; (b) for patients with PSA < 1.0 ng/mL, the treatment planning CT can substitute for a diagnostic CT scan; (c) a low-field, radiation planning MRI can replace the diagnostic MRI if the patient refuses or cannot obtain a high-field MRI]
- •Bone scan OR advanced nuclear imaging study within 120 days prior to enrollment for patients with PSA > 1.0 ng/mL
- •Age >= 18
- •Karnofsky performance status (KPS) >= 70 and/or Eastern Cooperative Oncology Group (ECOG) =< 2
- •Ability to understand, and willingness to sign, the written informed consent
排除标准
- •Patients with any evidence of distant metastases. Note, evidence of lymphadenopathy below the level of the renal arteries can be deemed loco regional per the discretion of the investigator
- •Patients with neuroendocrine or small cell carcinoma of the prostate
- •Prior pelvic radiotherapy
- •History of Crohn's disease, ulcerative colitis, or ataxia telangiectasia
研究组 & 干预措施
Treatment (SBRT, hormone therapy)
Patients undergo SBRT every other day or on consecutive days for up to 14 days. Patients may receive hormonal therapy at the discretion of the treating physician.
干预措施: Hormone Therapy (Drug)
Treatment (SBRT, hormone therapy)
Patients undergo SBRT every other day or on consecutive days for up to 14 days. Patients may receive hormonal therapy at the discretion of the treating physician.
干预措施: Stereotactic Body Radiation Therapy (Radiation)
结局指标
主要结局
Change of Expanded Prostate Cancer Index (EPIC) score for the gastrointestinal domain
时间窗: Baseline up to 2 years
EPIC assessed the disease-specific aspects of prostate cancer and its therapies within the gastrointestinal summary domain. Response options for each EPIC item formed a Likert scale, and multi-item scale scores were transformed linearly to a 0-100 scale, with higher scores representing better Health-Related QoL.
Change of Expanded Prostate Cancer Index (EPIC) score for the genitourinary domain
时间窗: Baseline up to 2 years
EPIC assessed the disease-specific aspects of prostate cancer and its therapies within the genitourinary summary domain. Response options for each EPIC item formed a Likert scale, and multi-item scale scores were transformed linearly to a 0-100 scale, with higher scores representing better Health-Related QoL.
次要结局
- Distant metastasis-free survival(Up to 5 years)
- Patient-reported gastrointestinal (GI) symptoms(At 3 months, 6 months, 1year, and 5 years)
- Patient-reported genitourinary (GU) symptoms(At 3 months, 6 months, 1year, and 5 years)
- Incidence of acute physician scored adverse events(Up to 5 years)
- Cumulative incidence of physician scored adverse events(Up to 5 years)
- Progression-free survival(Up to 5 years)
- Cumulative incidence of biochemical recurrence(Up to 5 years)