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試験進捗状況 一般募集中/Open public recruiting
UMIN試験ID UMIN000020674
受付番号 R000023857
科学的試験名 前立腺癌に対し放射線治療を行った患者の排尿障害に対するタダラフィルの効果(多施設共同・ランダム化・非盲検試験)
一般公開日(本登録希望日) 2016/01/21
最終更新日 2016/11/29

※ 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 前立腺癌に対し放射線治療を行った患者の排尿障害に対するタダラフィルの効果(多施設共同・ランダム化・非盲検試験) A Randomized, Open-Label, Multicenter study to evaluate effect of tadalafil on lower urinary tract symptoms in patients with prostate cancer treated after radiotherapy (T-addon-RT trial)
一般向け試験名略称/Acronym 前立腺癌放射線治療後の排尿障害に対するタダラフィルの多施設共同・ランダム化・非盲検試験 A Randomize study to evaluate effect of tadalafil on lower urinary tract symptoms in patients with prostate cancer treated after radiotherapy
科学的試験名/Scientific Title 前立腺癌に対し放射線治療を行った患者の排尿障害に対するタダラフィルの効果(多施設共同・ランダム化・非盲検試験) A Randomized, Open-Label, Multicenter study to evaluate effect of tadalafil on lower urinary tract symptoms in patients with prostate cancer treated after radiotherapy (T-addon-RT trial)
科学的試験名略称/Scientific Title:Acronym 前立腺癌放射線治療後の排尿障害に対するタダラフィルの多施設共同・ランダム化・非盲検試験 A Randomize study to evaluate effect of tadalafil on lower urinary tract symptoms in patients with prostate cancer treated after radiotherapy
試験実施地域/Region
日本/Japan

対象疾患/Condition
対象疾患名/Condition 放射線治療後の前立腺癌 Prostate cancer treated after radiotherapy
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 前立腺癌に対し放射線治療を行った患者の排尿障害に対するタダラフィルの効果を検討する

This is a randomized, open-label, multinational, 12-week study to evaluating efficacy of tadalafil tadalafil on lower urinary tract symptoms in patients with prostate cancer treated after radiotherapy
目的2/Basic objectives2 有効性/Efficacy
目的2 -その他詳細/Basic objectives -Others

試験の性質1/Trial characteristics_1 探索的/Exploratory
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 12週後のIPSSの変化 Change from Baseline to 12 Week of International Prostate Symptom Score (IPSS)

副次アウトカム評価項目/Key secondary outcomes 12週後のIPSSサブスコアの変化、勃起、残尿量、酸化ストレス、血圧、PSA、テストステロンの変化、安全性、 Change from Baseline to 12 Week of
IPSS Irritative Subscore
IPSS Voiding (Obstructive) Subscore
IPSS Quality of Life (QoL) Index
Uroflowmetry Parameter: Peak Flow Rate (Qmax)
Number of Participants with Adverse Events International Index of Erectile Function (IIEF)
Blood Pressure
Postvoid Residual Volume (PVR)
Prostate Specific Antigen (PSA)
Testosterone
oxygen stress

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 並行群間比較/Parallel
ランダム化/Randomization ランダム化/Randomized
ランダム化の単位/Randomization unit 個別/Individual
ブラインド化/Blinding オープン/Open -no one is blinded
コントロール/Control 無治療対照/No treatment
層別化/Stratification いいえ/NO
動的割付/Dynamic allocation いいえ/NO
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 封筒法/Numbered container method

介入/Intervention
群数/No. of arms 2
介入の目的/Purpose of intervention 治療・ケア/Treatment
介入の種類/Type of intervention
医薬品/Medicine
介入1/Interventions/Control_1 Tadalafil 5mg one a day, for 12 weeks Tadalafil 5mg one a day, for 12 weeks
介入2/Interventions/Control_2 Observation for 12 weeks, continuation of concomitant argents Observation for 12 weeks, continuation of concomitant argents
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
99 歳/years-old 未満/>
性別/Gender 男/Male
選択基準/Key inclusion criteria Males, 20 years or older, in patients with prostate cancer treated after radiotherapy;, including lower urinary tract symptoms (IPSS>7, or nocturia >1) who were not taking tadalafil
Agree not to change prostate cancer or use erectile dysfunction treatments anytime during the study
Have not taken phosphodiesterase type 5 (PDE5) inhibitors for specified duration of time prior to Visit 1.
Without biochemical recurrence (prostate specific antigen < 2.0) at the visit 1.
Males, 20 years or older, in patients with prostate cancer treated after radiotherapy;, including lower urinary tract symptoms (IPSS>7, or nocturia >1) who were not taking tadalafil
Agree not to change prostate cancer or use erectile dysfunction treatments anytime during the study
Have not taken phosphodiesterase type 5 (PDE5) inhibitors for specified duration of time prior to Visit 1.
Without biochemical recurrence (prostate specific antigen < 2.0) at the visit 1.
除外基準/Key exclusion criteria Prostate specific antigen (PSA) beyond 2.0 ng/mL defined for study at Visit 1.
History of urinary retention or lower urinary tract (bladder) stones within 6 months of Visit 1.
History of urethral obstruction due to stricture, valves, sclerosis, or tumor at Visit 1.
Clinical evidence of recurrent prostate cancer at Visit 1.
Clinical evidence of any of the bladder or urinary tract conditions, which may affect lower urinary tract symptom at Visit 1.
History of cardiac conditions, including angina requiring certain treatment with nitrates, unstable angina defined for study, positive cardiac stress test before starting the study.
History of significant central nervous system (CNS) injuries (including stroke or spinal cord injury) within 6 months of Visit 1.
Use of any nitrates, cancer chemotherapy, androgens, antiandrogens, estrogens, luteinizing hormone-releasing hormone (LHRH) agonists/antagonists, or anabolic steroids at Visit 1.
History of drug, alcohol, or substance abuse within the 6 months before Visit 1.
Have any condition, limitation, or disease that could, in the judgment of the investigator, preclude evaluation of response to tadalafil
Prostate specific antigen (PSA) beyond 2.0 ng/mL defined for study at Visit 1.
History of urinary retention or lower urinary tract (bladder) stones within 6 months of Visit 1.
History of urethral obstruction due to stricture, valves, sclerosis, or tumor at Visit 1.
Clinical evidence of recurrent prostate cancer at Visit 1.
Clinical evidence of any of the bladder or urinary tract conditions, which may affect lower urinary tract symptom at Visit 1.
History of cardiac conditions, including angina requiring certain treatment with nitrates, unstable angina defined for study, positive cardiac stress test before starting the study.
History of significant central nervous system (CNS) injuries (including stroke or spinal cord injury) within 6 months of Visit 1.
Use of any nitrates, cancer chemotherapy, androgens, antiandrogens, estrogens, luteinizing hormone-releasing hormone (LHRH) agonists/antagonists, or anabolic steroids at Visit 1.
History of drug, alcohol, or substance abuse within the 6 months before Visit 1.
Have any condition, limitation, or disease that could, in the judgment of the investigator, preclude evaluation of response to tadalafil
目標参加者数/Target sample size 100

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

ミドルネーム
大山 力

ミドルネーム
Chikara Ohyama
所属組織/Organization 弘前大学医学部 Hirosaki University Graduate School of Medicine
所属部署/Division name 泌尿器科 Department of Urology
郵便番号/Zip code
住所/Address 青森県弘前市 5 Zaifu-chou, Hirosaki, Japan
電話/TEL +81172395091
Email/Email coyama@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 弘前大学医学部 Hirosaki University Graduate School of Medicine
部署名/Division name 泌尿器科 Department of Urology
郵便番号/Zip code
住所/Address 5 Zaifu-chou 5 Zaifu-chou, Hirosaki, Japan
電話/TEL +81172395091
試験のホームページURL/Homepage URL
Email/Email shingorilla2@gmail.com

実施責任組織/Sponsor
機関名/Institute 弘前大学 Hirosaki University Graduate 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 その他 Oyokyo Kidney Research Institute
機関名/Organization
(機関選択不可の場合)
鷹揚郷腎研究所
組織名/Division
組織の区分/Category of Funding Organization 財団/Non profit foundation
研究費拠出国/Nationality of Funding Organization JAPAN JAPAN

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
2016 01 21

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 一般募集中/Open public recruiting
プロトコル確定日/Date of protocol fixation
2016 01 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
2016 01 20
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
2016 01 21
最終更新日/Last modified on
2016 11 29


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=R000023857
URL(英語) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023857

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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