NCT01368588进行中（未招募）3 期
Androgen Deprivation Therapy and High Dose Radiotherapy With or Without Whole-Pelvic Radiotherapy in Unfavorable Intermediate or Favorable High Risk Prostate Cancer: A Phase III Randomized Trial
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 2,590
- 试验地点
- 954
- 主要终点
- Overall Survival
研究概览
简要总结
RATIONALE: Androgens can cause the growth of prostate cancer cells. Androgen deprivation therapy may stop the adrenal glands from making androgens. Radiation therapy uses high-energy x-rays to kill tumor cells.
PURPOSE: This randomized phase III trial studies androgen-deprivation therapy and radiation therapy in treating patients with prostate cancer.
详细描述
OBJECTIVES:
Primary
- Demonstrate that prophylactic, neoadjuvant androgen-deprivation therapy (NADT) combined with whole-pelvic radiation therapy (WPRT) improves overall survival (OS) compared with NADT combined with prostate and seminal vesicle radiation therapy (RT), with both arms receiving a high-dose prostate boost delivered by intensity-modulated RT (IMRT), external-beam RT (EBRT), high-dose-rate (HDR) brachytherapy, or permanent prostate implant (PPI).
Secondary
- Demonstrate that prophylactic WPRT improves biochemical control.
- Determine the distant metastasis (DM)-free survival.
- Determine the cause-specific survival (CSS).
- Compare acute and late treatment-adverse events between patients receiving NADT and WPRT versus NADT, P, and SV RT.
- Determine whether health-related quality of life (HRQOL), as measured by the Expanded Prostate Cancer Index Composite (EPIC), significantly worsens with increasing aggressiveness of treatment (i.e., Arm 2, NADT + WPRT).
- Determine whether more aggressive treatment (Arm 2, NADT + WPRT) is associated with a greater increase in fatigue (PROMIS Fatigue Short Form) from baseline to last week of treatment, and a greater increase in circulating inflammatory markers (IL-1, IL-1ra, IL-6, tumor necrosis factor (TNF)-alpha, and C-reactive protein).
- Demonstrate an incremental gain in OS and CSS with more aggressive therapy that outweighs any detriments in the primary generic domains of HRQOL (i.e., mobility, self-care, usual activities, pain/discomfort, and anxiety/depression).
- Determine whether changes in fatigue from baseline to the next three time points (week prior to RT, last week of treatment, and 3 months after treatment) are associated with changes in circulating cytokines, mood, sleep, and daily activities across the same time points.
- Collect paraffin-embedded tissue blocks, plasma, whole blood, and urine for planned and future translational research analyses.
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
- •DISEASE CHARACTERISTICS:
- •Pathologically (histologically or cytologically) proven diagnosis of prostatic adenocarcinoma within 180 days of registration at moderate to high risk for recurrence as determined by one of the following combinations:
- •Gleason score 7-10 + T1c-T2b (palpation) + PSA < 50 ng/ml (includes intermediate and high risk patients);
- •Gleason score 6 + T2c-T4 (palpation) + PSA < 50 ng/ml
- •ORGleason score 6 + ≥ 50% (positive) biopsies + PSA < 50 ng/ml;
- •Gleason score 6 + T1c-T2b (palpation) + PSA > 20 ng/ml. Patients previously diagnosed with low risk prostate cancer undergoing active surveillance who are re-biopsied and found to have unfavorable intermediate risk disease or favorable high risk disease according to the protocol criteria are eligible for enrollment within 180 days of the repeat biopsy procedure.
- •History/physical examination (to include at a minimum digital rectal examination of the prostate and examination of the skeletal system and abdomen) within 90 days prior to registration.
- •Clinically negative lymph nodes as established by imaging (pelvic ± abdominal CT or MR), (but not by nodal sampling, or dissection) within 90 days prior to registration.
- •Patients with lymph nodes equivocal or questionable by imaging are eligible if the nodes are ≤ 1.5 cm.
- •*No evidence of bone metastases (M0) on bone scan within 120 days prior to registration (Na F PET/CT is an acceptable substitute).
- •Equivocal bone scan findings are allowed if plain films (or CT or MRI) are negative for metastasis.
- •*Baseline serum PSA value performed with an FDA-approved assay (e.g., Abbott, Hybritech) within 120 days prior to registration.
- •Study entry PSA should not be obtained during the following time frames: (1) 10- day period following prostate biopsy; (2) following initiation of hormonal therapy; (3) within 30 days after discontinuation of finasteride; (4) within 90 days after discontinuation of dutasteride.
- •Zubrod Performance Status 0-1(unless otherwise specified);
- •Age ≥ 18;
- •CBC/differential obtained within 60 days prior to registration on study, with adequate bone marrow function defined as follows:
- •Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3;
- •Platelets ≥ 100,000 cells/mm3;
- •Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable.);
- •Patient must be able to provide study specific informed consent prior to study entry.
排除标准
- 未提供
结局指标
主要结局
Overall Survival
时间窗: From date of randomization to the date of death.
次要结局
- Prostate cancer-specific HRQOL change as measured by the EPIC-26 (bowel or urinary domain)(Date when baseline EPIC-26 completed to 6 months post radiation therapy, 1 year post radiation therapy and 5 years post radiation therapy.)
- Cause-specific survival(From date of randomization to the date of death due to prostate cancer.)
- Biochemical failure by the Phoenix definition (PSA ≥ 2 ng/mL over the nadir PSA)(From date of randomization to the date of first biochemical failure by phoenix definition within 5 years of randomization.)
- Time to "late" grade 3+ adverse events as assessed by CTCAE current version(From protocol treatment start date to the date of the first late grade 3+ adverse event occurring more than 30 days after the completion of radiation therapy.)
- Incidence of "acute" adverse events as assessed by the Common Toxicity Criteria for Adverse Effects (CTCAE) current version(From protocol treatment start date to the date of first occurrence of worst severity of the adverse event </= 30 days from completion of radiation therapy.)
- Fatigue status as measured by the Patient-Reported Outcome Measurement Information System (PROMIS) fatigue-domain change score(From the date when the baseline PROMIS is completed to the last week of treatment.)
- Assessment and comparison of Quality Adjusted Life Years (QALYs)(From the baseline QALYs assessment to the last week of radiation therapy (RT), 3 months post RT, 6 months post RT, 1 year post RT and 5 years post RT.)
- Distant metastasis-free survival(From date of randomization to the date of first documented distant metastasis or date of first clinical and/or radiographic appearance of disseminated disease.)
研究者
研究点 (954)
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