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利用者名:
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試験進捗状況 開始前/Preinitiation
UMIN試験ID UMIN000034795
受付番号 R000039684
科学的試験名 転移性前立腺癌に対する局所介入の有効性についての臨床試験
一般公開日(本登録希望日) 2019/02/01
最終更新日 2018/11/07

※ 本ページ収載の情報は、臨床試験に関する情報公開を目的として、UMINが開設しているUMIN臨床試験登録システムに提供された臨床試験情報です。
※ 特定の医薬品や治療法等については、医療関係者や一般の方に向けて広告することは目的としていません。


基本情報/Basic information
一般向け試験名/Public title 転移性前立腺癌に対する局所介入の有効性についての臨床試験 Impact of local therapy for metastatic prostate cancer
一般向け試験名略称/Acronym 転移性前立腺癌に対する局所介入の有効性についての臨床試験 Impact of local therapy for metastatic prostate cancer
科学的試験名/Scientific Title 転移性前立腺癌に対する局所介入の有効性についての臨床試験 Impact of local therapy for metastatic prostate cancer
科学的試験名略称/Scientific Title:Acronym 転移性前立腺癌に対する局所介入の有効性についての臨床試験 Impact of local therapy for metastatic prostate cancer
試験実施地域/Region
日本/Japan

対象疾患/Condition
対象疾患名/Condition 転移性前立腺癌 metastatic prostate cancer
疾患区分1/Classification by specialty
泌尿器科学/Urology
疾患区分2/Classification by malignancy 悪性腫瘍/Malignancy
ゲノム情報の取扱い/Genomic information いいえ/NO

目的/Objectives
目的1/Narrative objectives1 転移性前立腺癌に対する局所介入の有効性・安全性を検討する To investigate the efficacy and safety of local therapy for metastatic prostate cancer
目的2/Basic objectives2 安全性・有効性/Safety,Efficacy
目的2 -その他詳細/Basic objectives -Others

試験の性質1/Trial characteristics_1
試験の性質2/Trial characteristics_2
試験のフェーズ/Developmental phase

評価/Assessment
主要アウトカム評価項目/Primary outcomes 全生存期間 Overall survival
副次アウトカム評価項目/Key secondary outcomes 無増悪生存期間、PSAレスポンス、奏効率 Progression-free survival
PSA response
Objective response

基本事項/Base
試験の種類/Study type 介入/Interventional

試験デザイン/Study design
基本デザイン/Basic design 継続・拡大投与/expanded access
ランダム化/Randomization 非ランダム化/Non-randomized
ランダム化の単位/Randomization unit
ブラインド化/Blinding オープン/Open -no one is blinded
コントロール/Control ヒストリカル/Historical
層別化/Stratification
動的割付/Dynamic allocation
試験実施施設の考慮/Institution consideration
ブロック化/Blocking
割付コードを知る方法/Concealment

介入/Intervention
群数/No. of arms 1
介入の目的/Purpose of intervention 治療・ケア/Treatment
介入の種類/Type of intervention
手技/Maneuver
介入1/Interventions/Control_1 Standard therapy + Operation or radiotherapy Standard therapy + Operation or radiotherapy
介入2/Interventions/Control_2

介入3/Interventions/Control_3

介入4/Interventions/Control_4

介入5/Interventions/Control_5

介入6/Interventions/Control_6

介入7/Interventions/Control_7

介入8/Interventions/Control_8

介入9/Interventions/Control_9

介入10/Interventions/Control_10


適格性/Eligibility
年齢(下限)/Age-lower limit
20 歳/years-old 以上/<=
年齢(上限)/Age-upper limit
90 歳/years-old 以下/>=
性別/Gender 男/Male
選択基準/Key inclusion criteria Histologically proven adenocarcinoma of the prostate
Evidence of metastasis by magnetic resonance imaging (MRI)/computed tomography (CT) scan, bone scan, or histologic confirmation
Clinical stage M1a (distant lymph node positive), or M1b (bone metastasis)
If solitary lesion, metastasis confirmed with either biopsy or two independent imaging modalities (i.e. CT and PET [positron emission tomography], bone scan and MRI, modality at the discretion of the treating physician)
No previous local therapy for prostate cancer
Give informed consent
Prostate deemed resectable by surgeon
Started antiandrogen therapy (ADT) no longer than 6 months prior to randomization
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Hemoglobin (HgB) >= 9 g/dL compatible for surgery
Platelets > 80,000 compatible for surgery
Aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) =< 2x upper limit of normal (ULN) compatible for surgery
Histologically proven adenocarcinoma of the prostate
Evidence of metastasis by magnetic resonance imaging (MRI)/computed tomography (CT) scan, bone scan, or histologic confirmation
Clinical stage M1a (distant lymph node positive), or M1b (bone metastasis)
If solitary lesion, metastasis confirmed with either biopsy or two independent imaging modalities (i.e. CT and PET [positron emission tomography], bone scan and MRI, modality at the discretion of the treating physician)
No previous local therapy for prostate cancer
Give informed consent
Prostate deemed resectable by surgeon
Started antiandrogen therapy (ADT) no longer than 6 months prior to randomization
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Hemoglobin (HgB) >= 9 g/dL compatible for surgery
Platelets > 80,000 compatible for surgery
Aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) =< 2x upper limit of normal (ULN) compatible for surgery
除外基準/Key exclusion criteria Refuses to give informed consent
Deemed to have unresectable disease by surgeon
Received ADT for more than 6 months prior to randomization
Life expectancy of less than 6 months prior to randomization
Known spinal cord compression
M1c disease (solid organ metastasis)
Deep vein thrombosis (DVT) / pulmonary embolism (PE) in the past 6 months prior to randomization
Previous local therapy for prostate cancer
Previous chemotherapy for prostate cancer
Patients who have chemotherapy, radiotherapy or oral antifungal agents (ketoconazole, itraconazole, fluconazole) within 3 weeks prior to entering the study or those who have not recovered (e.g. back to baseline or grade 1) from adverse events due to agents administered more than 3 weeks earlier
Any drug interactions that are deemed to be medically significant would require a washout of 5-half-lives of the interaction agent before enrollment can occur
Refuses to give informed consent
Deemed to have unresectable disease by surgeon
Received ADT for more than 6 months prior to randomization
Life expectancy of less than 6 months prior to randomization
Known spinal cord compression
M1c disease (solid organ metastasis)
Deep vein thrombosis (DVT) / pulmonary embolism (PE) in the past 6 months prior to randomization
Previous local therapy for prostate cancer
Previous chemotherapy for prostate cancer
Patients who have chemotherapy, radiotherapy or oral antifungal agents (ketoconazole, itraconazole, fluconazole) within 3 weeks prior to entering the study or those who have not recovered (e.g. back to baseline or grade 1) from adverse events due to agents administered more than 3 weeks earlier
Any drug interactions that are deemed to be medically significant would require a washout of 5-half-lives of the interaction agent before enrollment can occur
目標参加者数/Target sample size 50

責任研究者/Research contact person
責任研究者/Name of lead principal investigator

ミドルネーム
畠山真吾

ミドルネーム
Shingo Hatakeyama
所属組織/Organization 弘前大学 Hirosaki University School of Medicine
所属部署/Division name 泌尿器科 Urology
郵便番号/Zip code
住所/Address 弘前市在府町5 5 zaifu-chou, Hirosaki, Japan
電話/TEL 0172395091
Email/Email shingoh@hirosaki-u.ac.jp

試験問い合わせ窓口/Public contact
試験問い合わせ窓口担当者/Name of contact person

ミドルネーム
畠山真吾

ミドルネーム
Shingo Hatakeyama
組織名/Organization 弘前大学 Hirosaki University School of Medicine
部署名/Division name 泌尿器科 Urology
郵便番号/Zip code
住所/Address 弘前市在府町5 5 zaifu-chou, Hirosaki, Japan
電話/TEL 0172395091
試験のホームページURL/Homepage URL
Email/Email shingoh@hirosaki-u.ac.jp

実施責任組織/Sponsor
機関名/Institute 弘前大学 Hirosaki University School of Medicine
機関名/Institute
(機関選択不可の場合)

部署名/Department

研究費提供組織/Funding Source
機関名/Organization 科学技術振興機構 Japan society for the promotion of science
機関名/Organization
(機関選択不可の場合)

組織名/Division
組織の区分/Category of Funding Organization 日本の官庁/Japanese Governmental office
研究費拠出国/Nationality of Funding Organization


その他の関連組織/Other related organizations
共同実施組織/Co-sponsor

その他の研究費提供組織/Name of secondary funder(s)


IRB等連絡先(公開)/IRB Contact (For public release)
組織名/Organization

住所/Address

電話/Tel
Email/Email

他機関から発行された試験ID/Secondary IDs
他機関から発行された試験ID/Secondary IDs いいえ/NO
試験ID1/Study ID_1
ID発行機関1/Org. issuing International ID_1

試験ID2/Study ID_2
ID発行機関2/Org. issuing International ID_2

治験届/IND to MHLW

試験実施施設/Institutions
試験実施施設名称/Institutions

その他の管理情報/Other administrative information
一般公開日(本登録希望日)/Date of disclosure of the study information
2019 02 01

関連情報/Related information
プロトコル掲載URL/URL releasing protocol
試験結果の公開状況/Publication of results 未公表/Unpublished

結果/Result
結果掲載URL/URL related to results and publications
組み入れ参加者数/Number of participants that the trial has enrolled
主な結果/Results

主な結果入力日/Results date posted
結果掲載遅延/Results Delayed
結果遅延理由/Results Delay Reason

最初の試験結果の出版日/Date of the first journal publication of results
参加者背景/Baseline Characteristics

参加者の流れ/Participant flow

有害事象/Adverse events

評価項目/Outcome measures

個別症例データ共有計画/Plan to share IPD

個別症例データ共有計画の詳細/IPD sharing Plan description


試験進捗状況/Progress
試験進捗状況/Recruitment status 開始前/Preinitiation
プロトコル確定日/Date of protocol fixation
2018 11 01
倫理委員会による承認日/Date of IRB
登録・組入れ開始(予定)日/Anticipated trial start date
2019 02 01
フォロー終了(予定)日/Last follow-up date
入力終了(予定)日/Date of closure to data entry
データ固定(予定)日/Date trial data considered complete
解析終了(予定)日/Date analysis concluded

その他/Other
その他関連情報/Other related information


管理情報/Management information
登録日時/Registered date
2018 11 07
最終更新日/Last modified on
2018 11 07


閲覧ページへのリンク/Link to view the page
URL(日本語) https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000039684
URL(英語) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039684

研究計画書
登録日時 ファイル名

研究症例データ仕様書
登録日時 ファイル名

研究症例データ
登録日時 ファイル名


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