臨床試験情報
| 臨床試験ID | : | UMIN000034795 |
| 情報提供元 | : | 大学病院医療情報ネットワーク研究センター |
| 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 |
| 試験の概要 | : | 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 |
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基本情報 患者さん一人一人の状況に応じた判断が必要ですので、詳しくは診療を担当している医師にご相談ください |
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| 対象疾患名 | 転移性前立腺癌 |
| 試験のホームページURL | |
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実施施設＆進捗状況 | |
| 試験実施施設 | |
| 試験のフェーズ | 該当せず |
| 試験進捗状況 | 開始前 |
| 公開日・最終情報更新日 | 2018/11/07 |
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試験に参加できる条件 | |
| 年齢・性別 | 20歳 ～ 男 |
| 選択基準 | Histologically proven adenocarcinoma of the prostateEvidence of metastasis by magnetic resonance imaging (MRI)/computed tomography (CT) scan, bone scan, or histologic confirmationClinical 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 cancerGive informed consentProstate deemed resectable by surgeonStarted antiandrogen therapy (ADT) no longer than 6 months prior to randomizationEastern Cooperative Oncology Group (ECOG) performance status of 0 or 1Hemoglobin (HgB) >= 9 g/dL compatible for surgeryPlatelets > 80,000 compatible for surgeryAspartate aminotransferase (AST)/ alanine aminotransferase (ALT) =< 2x upper limit of normal (ULN) compatible for surgery |
| 除外基準 | 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 |
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問い合わせ先 | |
| 実施責任組織 | |
| 問い合わせ先組織名 | 弘前大学 |
| 部署名・担当者名 | 泌尿器科 畠山真吾 |
| 電話・Email | 0172395091 shingoh@hirosaki-u.ac.jp |
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評価＆介入 | |
| 試験の種類 | 該当無し |
| 介入の目的 | 治療・ケア |
| 介入の詳細 | Standard therapy + Operation or radiotherapy |
| 主要な評価項目・方法 | 全生存期間 |
| 副次的な評価項目・方法 | 無増悪生存期間、PSAレスポンス、奏効率 |
よりよい情報提供を行うために、ご協力をお願いいたします。
