多西紫杉醇、雄激素剥夺和质子治疗高危前列腺癌 (PR05)
2023年9月14日 更新者：University of Florida
一项以质子为基础的放射治疗与选择性盆腔淋巴结照射、联合多西紫杉醇和辅助雄激素剥夺治疗高危前列腺癌的 II 期研究
本研究的目的是了解质子放疗联合低剂量化疗和激素治疗对患者及其癌症有什么影响，无论好坏。
研究概览
研究类型
介入性
注册 (实际的)
77
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Florida
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Jacksonville、Florida、美国、32206
- University of Florida Proton Therapy Institute
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
描述
纳入标准：
* 前列腺腺癌。
排除标准：
- 先前的前列腺癌治疗，例如化疗和/或盆腔放疗。
- 影响直肠的活动性炎症性肠病（憩室炎、克罗恩病或溃疡性结肠炎）。 （允许不影响直肠的非活动性憩室炎和克罗恩病。）
- 髋关节置换史。
- 先前的盆腔内手术。 这包括以下内容：
- 除息肉切除术或痔疮切除术或环扎术外的经直肠或直肠手术
- 经腹盆腔手术
- 膀胱手术
- 既往心肌梗塞 (MI) 或充血性心力衰竭 (CHF)。
- 服用锯棕榈或甲氨蝶呤并且不能或不愿在放疗期间停止使用。
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：高风险组 A (HR-A)
< 15% + 淋巴结 (LN) 的风险
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在 30 次前列腺 + 精囊 (SV) 治疗中总共有 54 个钴灰当量 (CGE)，然后在 13-15 次前列腺 +/- SV 治疗中质子增强总计 23.4-27 CGE。
在放射治疗 (RT) 期间每周使用低剂量多西紫杉醇，随后进行为期 6 个月的雄激素剥夺治疗。
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实验性的：HR-B
> 15% + LN 的风险
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对前列腺 + SV + LN 的 25 次治疗共计 45 Gy，然后在对前列腺 + SV 的 18-20 次治疗中总计 32.4-36 CGE 的质子增强。
RT 期间每周低剂量多西紫杉醇，随后进行 6 个月的雄激素剥夺治疗。
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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急性 3 级或更高的治疗相关毒性率。
大体时间：放射治疗完成后 6 个月
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根据 CTCAE 3.0 版标准，经历 3 级或更高级别急性治疗相关毒性的参与者人数。
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放射治疗完成后 6 个月
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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收集和分析生活质量、治疗相关的晚期发病率、疾病控制和生存结果参数。
大体时间：放疗后：每 6 个月一次，持续 3 年，然后每年一次，持续 20 年
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放疗后：每 6 个月一次，持续 3 年，然后每年一次，持续 20 年
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收集和分析可能影响生活质量、疾病控制、发病率和/或生存结果的治疗、生物学和诊断信息。
大体时间：放疗后：每 6 个月一次，持续 3 年，然后每年一次，持续 20 年
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放疗后：每 6 个月一次，持续 3 年，然后每年一次，持续 20 年
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Nancy P Mendenhall, MD、University of Florida Proton Therapy Institute
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
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- Vargas C, Yan D, Kestin LL, Krauss D, Lockman DM, Brabbins DS, Martinez AA. Phase II dose escalation study of image-guided adaptive radiotherapy for prostate cancer: use of dose-volume constraints to achieve rectal isotoxicity. Int J Radiat Oncol Biol Phys. 2005 Sep 1;63(1):141-9. doi: 10.1016/j.ijrobp.2004.12.017.
- Hanks GE, Pajak TF, Porter A, Grignon D, Brereton H, Venkatesan V, Horwitz EM, Lawton C, Rosenthal SA, Sandler HM, Shipley WU; Radiation Therapy Oncology Group. Phase III trial of long-term adjuvant androgen deprivation after neoadjuvant hormonal cytoreduction and radiotherapy in locally advanced carcinoma of the prostate: the Radiation Therapy Oncology Group Protocol 92-02. J Clin Oncol. 2003 Nov 1;21(21):3972-8. doi: 10.1200/JCO.2003.11.023. Erratum In: J Clin Oncol. 2004 Jan 15;22(2):386.
- Soloway MS, Pareek K, Sharifi R, Wajsman Z, McLeod D, Wood DP Jr, Puras-Baez A; Lupron Depot Neoadjuvant Prostate Cancer Study Group. Neoadjuvant androgen ablation before radical prostatectomy in cT2bNxMo prostate cancer: 5-year results. J Urol. 2002 Jan;167(1):112-6.
- Kestin LL, Martinez AA, Stromberg JS, Edmundson GK, Gustafson GS, Brabbins DS, Chen PY, Vicini FA. Matched-pair analysis of conformal high-dose-rate brachytherapy boost versus external-beam radiation therapy alone for locally advanced prostate cancer. J Clin Oncol. 2000 Aug;18(15):2869-80. doi: 10.1200/JCO.2000.18.15.2869.
- Demanes DJ, Rodriguez RR, Schour L, Brandt D, Altieri G. High-dose-rate intensity-modulated brachytherapy with external beam radiotherapy for prostate cancer: California endocurietherapy's 10-year results. Int J Radiat Oncol Biol Phys. 2005 Apr 1;61(5):1306-16. doi: 10.1016/j.ijrobp.2004.08.014.
- Martinez AA, Demanes DJ, Galalae R, Vargas C, Bertermann H, Rodriguez R, Gustafson G, Altieri G, Gonzalez J. Lack of benefit from a short course of androgen deprivation for unfavorable prostate cancer patients treated with an accelerated hypofractionated regime. Int J Radiat Oncol Biol Phys. 2005 Aug 1;62(5):1322-31. doi: 10.1016/j.ijrobp.2004.12.053.
- Dearnaley DP, Hall E, Lawrence D, Huddart RA, Eeles R, Nutting CM, Gadd J, Warrington A, Bidmead M, Horwich A. Phase III pilot study of dose escalation using conformal radiotherapy in prostate cancer: PSA control and side effects. Br J Cancer. 2005 Feb 14;92(3):488-98. doi: 10.1038/sj.bjc.6602301.
- Shipley WU, Verhey LJ, Munzenrider JE, Suit HD, Urie MM, McManus PL, Young RH, Shipley JW, Zietman AL, Biggs PJ, et al. Advanced prostate cancer: the results of a randomized comparative trial of high dose irradiation boosting with conformal protons compared with conventional dose irradiation using photons alone. Int J Radiat Oncol Biol Phys. 1995 Apr 30;32(1):3-12. doi: 10.1016/0360-3016(95)00063-5.
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- Fuks Z, Leibel SA, Wallner KE, Begg CB, Fair WR, Anderson LL, Hilaris BS, Whitmore WF. The effect of local control on metastatic dissemination in carcinoma of the prostate: long-term results in patients treated with 125I implantation. Int J Radiat Oncol Biol Phys. 1991 Aug;21(3):537-47. doi: 10.1016/0360-3016(91)90668-t.
- Bolla M, Collette L, Blank L, Warde P, Dubois JB, Mirimanoff RO, Storme G, Bernier J, Kuten A, Sternberg C, Mattelaer J, Lopez Torecilla J, Pfeffer JR, Lino Cutajar C, Zurlo A, Pierart M. Long-term results with immediate androgen suppression and external irradiation in patients with locally advanced prostate cancer (an EORTC study): a phase III randomised trial. Lancet. 2002 Jul 13;360(9327):103-6. doi: 10.1016/s0140-6736(02)09408-4.
- D'Amico AV, Loffredo M, Renshaw AA, Loffredo B, Chen MH. Six-month androgen suppression plus radiation therapy compared with radiation therapy alone for men with prostate cancer and a rapidly increasing pretreatment prostate-specific antigen level. J Clin Oncol. 2006 Sep 1;24(25):4190-5. doi: 10.1200/JCO.2006.06.8239.
- Partin AW, Mangold LA, Lamm DM, Walsh PC, Epstein JI, Pearson JD. Contemporary update of prostate cancer staging nomograms (Partin Tables) for the new millennium. Urology. 2001 Dec;58(6):843-8. doi: 10.1016/s0090-4295(01)01441-8.
- Crook J, Ludgate C, Malone S, Lim J, Perry G, Eapen L, Bowen J, Robertson S, Lockwood G. Report of a multicenter Canadian phase III randomized trial of 3 months vs. 8 months neoadjuvant androgen deprivation before standard-dose radiotherapy for clinically localized prostate cancer. Int J Radiat Oncol Biol Phys. 2004 Sep 1;60(1):15-23. doi: 10.1016/j.ijrobp.2004.02.022.
- Roach M 3rd, DeSilvio M, Lawton C, Uhl V, Machtay M, Seider MJ, Rotman M, Jones C, Asbell SO, Valicenti RK, Han S, Thomas CR Jr, Shipley WS; Radiation Therapy Oncology Group 9413. Phase III trial comparing whole-pelvic versus prostate-only radiotherapy and neoadjuvant versus adjuvant combined androgen suppression: Radiation Therapy Oncology Group 9413. J Clin Oncol. 2003 May 15;21(10):1904-11. doi: 10.1200/JCO.2003.05.004.
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研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2009年12月1日
初级完成 (实际的)
2015年1月1日
研究完成 (实际的)
2022年4月11日
研究注册日期
首次提交
2009年12月24日
首先提交符合 QC 标准的
2009年12月24日
首次发布 (估计的)
2009年12月29日
研究记录更新
最后更新发布 (实际的)
2023年10月3日
上次提交的符合 QC 标准的更新
2023年9月14日
最后验证
2023年9月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.