Tri-Modality therapy with I-125 brachytherapy, external beam radiation therapy, and short- or long-term hormone therapy for high-risk localized prostate cancer (TRIP): study protocol for a phase III, multicenter, randomized, controlled trial.
Tri-Modality therapy with I-125 brachytherapy, external beam radiation therapy, and short- or long-term hormone therapy for high-risk localized prostate cancer (TRIP): study protocol for a phase III, multicenter, randomized, controlled trial.
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DOI：
10.1186/1471-2407-12-110
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发表时间：
2012-03-22
期刊：
影响因子：
3.8
通讯作者：
Namiki M
中科院分区：
文献类型：
--
作者：
Konaka H;Egawa S;Saito S;Yorozu A;Takahashi H;Miyakoda K;Fukushima M;Dokiya T;Yamanaka H;Stone NN;Namiki M
具有高Gleason评分、前列腺特异性抗原（PSA）水平升高和晚期临床分期的患者局部和全身复发的风险增加。最近的数据表明，更高的辐射剂量减少局部复发，并可能最终有利于生化，无转移和疾病特异性生存。没有关于这些患者长期激素治疗（HT）获益的随机数据。非常需要对高危前列腺癌（PCa）的HT、外束放射治疗（EBRT）和近距离放射治疗（BT）三联治疗的有效性和安全性进行前瞻性研究。这是一项采用BT、EBRT和HT三联疗法治疗高危PCa（TRIP）的III期、多中心、随机对照试验（RCT），将研究使用碘-125（125 I-BT）的BT后辅助HT和补充EBRT联合新辅助治疗和同时HT的影响。在2012年9月底之前，将入组共计340例高风险PCa患者，并将其随机分配至两个治疗组之一。这些患者将从超过41个机构招募，所有这些机构都具有125 I-BT的广泛经验。将对病理切片进行集中审查，以确认患者的合格性。患者通常在125 I-BT和补充EBRT之前和期间接受6个月HT联合雄激素阻断（CAB）。那些随机分配到长期HT组的患者随后将接受2年的辅助HT和促黄体生成素释放激素激动剂。所有受试者将在基线时接受评估，前30个月每3个月一次，然后每6个月一次，直至CAB开始后84个月。主要终点是生化无进展生存期。次要终点是总生存期、临床无进展生存期、疾病特异性生存期、挽救治疗非适应间期和不良事件。据我们所知，还没有前瞻性研究记录三联疗法治疗高危PCa的疗效和安全性。目前的随机对照试验预计将提供额外的见解的效力和局限性，增加2年的辅助HT的这种三模态的方法，并建立一个适当的治疗策略，高风险PCa。UMIN000003992
Patients with high Gleason score, elevated prostate specific antigen (PSA) level, and advanced clinical stage are at increased risk for both local and systemic relapse. Recent data suggests higher radiation doses decrease local recurrence and may ultimately benefit biochemical, metastasis-free and disease-specific survival. No randomized data is available on the benefits of long-term hormonal therapy (HT) in these patients. A prospective study on the efficacy and safety of trimodality treatment consisting of HT, external beam radiation therapy (EBRT), and brachytherapy (BT) for high-risk prostate cancer (PCa) is strongly required. This is a phase III, multicenter, randomized controlled trial (RCT) of trimodality with BT, EBRT, and HT for high-risk PCa (TRIP) that will investigate the impact of adjuvant HT following BT using iodine-125 (125I-BT) and supplemental EBRT with neoadjuvant and concurrent HT. Prior to the end of September 2012, a total of 340 patients with high-risk PCa will be enrolled and randomized to one of two treatment arms. These patients will be recruited from more than 41 institutions, all of which have broad experience with 125I-BT. Pathological slides will be centrally reviewed to confirm patient eligibility. The patients will commonly undergo 6-month HT with combined androgen blockade (CAB) before and during 125I-BT and supplemental EBRT. Those randomly assigned to the long-term HT group will subsequently undergo 2 years of adjuvant HT with luteinizing hormone-releasing hormone agonist. All participants will be assessed at baseline and every 3 months for the first 30 months, then every 6 months until 84 months from the beginning of CAB. The primary endpoint is biochemical progression-free survival. Secondary endpoints are overall survival, clinical progression-free survival, disease-specific survival, salvage therapy non-adaptive interval, and adverse events. To our knowledge, there have been no prospective studies documenting the efficacy and safety of trimodality therapy for high-risk PCa. The present RCT is expected to provide additional insight regarding the potency and limitations of the addition of 2 years of adjuvant HT to this trimodality approach, and to establish an appropriate treatment strategy for high-risk PCa. UMIN000003992
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影响因子：
6.6
作者：
Grossfeld, GD;Latini, DM;Carroll, PR
通讯作者：
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DOI：
10.1016/j.ijrobp.2004.08.003
发表时间：
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1997-01-15
影响因子：
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影响因子：
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作者：
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