RapidPlan を使用した放射線治療前立腺がん治療のための知識ベースの計画と人間主導の計画
前立腺がん放射線治療における迅速計画の知識ベース計画と人間主導計画のランダム化第 III 相試験
This phase III trial compares the effects of radiation therapy using RapidPlan, trademark, knowledge-based planning to human-driven planning in treating patients with prostate cancer. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill tumor cells and shrink tumors. Successful delivery of radiation requires planning to develop a treatment plan for how and where the radiation is to be delivered. RapidPlan is a knowledge-based treatment planning tool that automatically creates an optimal treatment plan based on identified targets and organs at risk for radiation exposure. Human-driven treatment planning by a dosimetrist, the current standard of care, requires significant resources and time and may vary within and among radiation centers. Giving radiation therapy with RapidPlan knowledge-based planning may have similar or less side effects compared to human-driven planning in treating patients with prostate cancer.
調査の概要
状態
条件
詳細な説明
PRIMARY OBJECTIVE:
I. To determine if RapidPlan knowledge-based planning is non-inferior to human-driven planning regarding treatment-related rates of grade 3 or higher genitourinary (GU) and gastrointestinal (GI) adverse events at 3 months post-radiotherapy for prostate cancer.
EXPLORATORY OBJECTIVES:
I. After completion of radiation therapy, determine the incidence of:
Ia. Grade 2 or greater GU and GI toxicity at 3 months (Common Terminology Criteria for Adverse Events [CTCAE] version 5); Ib. Quality of life 3 months post-radiotherapy; Ic. Rate of achieving dose-volume constraints. II. Determine if there are any statistical differences in dose-volumes results with RapidPlan knowledge-based planning.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A (HUMAN-DRIVEN): Patients receive human-driven treatment planning and undergo radiation therapy over 15-30 minutes on 5-44 fractions per standard of care. Additionally, patients undergo magnetic resonance imaging (MRI) pre-treatment and blood sample collection and positron emission tomography (PET) throughout study.
ARM B (KNOWLEDGE-BASED): Patients receive RapidPlan treatment planning and undergo radiation therapy over 15-30 minutes on 5-44 fractions per standard of care. Additionally, patients undergo MRI pre-treatment and blood sample collection and PET throughout study.
After completion of study treatment, patients are followed up at 3 and 12 months then yearly for up to year 5.
研究の種類
入学 (推定)
段階
- フェーズ 3
連絡先と場所
研究連絡先
- 名前：Clinical Trials Referral Office
- 電話番号：855-776-0015
- メール：mayocliniccancerstudies@mayo.edu
研究連絡先のバックアップ
- 名前：Cancer Clinical Trials Referral Office
- 電話番号：507-293-6386
研究場所
-
-
Arizona
-
Scottsdale、Arizona、アメリカ、85259
- 募集
- Mayo Clinic in Arizona
-
コンタクト：
- Clinical Trials Referral Office
- 電話番号：855-776-0015
- メール：mayocliniccancerstudies@mayo.edu
-
主任研究者：
- Nathan Y. Yu, MD
-
コンタクト：
- Cancer Clinical Trials Referral Office
- 電話番号：507-293-6386
-
-
Florida
-
Jacksonville、Florida、アメリカ、32224-9980
- まだ募集していません
- Mayo Clinic in Florida
-
コンタクト：
- Clinical Trials Referral Office
- 電話番号：855-776-0015
- メール：mayocliniccancerstudies@mayo.edu
-
コンタクト：
- Cancer Clinical Trials Referral Office
- 電話番号：507-293-6386
-
主任研究者：
- Homan Mohammadi, MD
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Patients must be at least 18 years old
- Histologically confirmed prostate cancer
- Clinical or pathologic stages T1c-T3b, Nx or N0-1, M0-1 (American Joint Committee on Cancer [AJCC] criteria 8th edition [Ed])
- Planned definitive dose radiotherapy to the prostate or prostate bed
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2 assessed within 90 days of enrollment
- Patients must sign Institutional Review Board (IRB) approved study specific informed consent
- Patients must complete all required pre-entry tests within the specified time frames
- Patients must be able to start treatment (radiation) within 180 days of study registration
- In case of confusion about the eligibility or ineligibility of an individual patient, the principal investigator (PI) can be used as the arbiter and a note to file will be added to the subject's regulatory binder to document outcome
Exclusion Criteria:
- Previous pelvic radiation > 5 Gy
- Planned delivery of radiotherapy to pelvic lymph nodes
- Planned delivery of brachytherapy of the prostate
- Active rectal diverticulitis, Crohn's disease affecting the rectum, or ulcerative colitis (non-active diverticulitis and Crohn's disease not affecting the rectum are allowed)
- Prior hip replacement or penile implant
- Major medical, addictive, or psychiatric illness which in the investigator's opinion, will prevent the consent process, completion of the treatment and/or interfere with follow-up. (consent by legal authorized representative is not permitted for this study)
- Indwelling or intermittent urinary catheter use
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：Arm A (human-driven treatment planning, radiation therapy)
Patients receive human-driven treatment planning and undergo radiation therapy over 15-30 minutes on 5-44 fractions per standard of care. Additionally, patients undergo MRI pre-treatment and blood sample collection and PET throughout study. |
Undergo blood sample collection
他の名前：
Undergo MRI
他の名前：
Ancillary studies Undergo PET
他の名前：
Undergo radiation therapy
他の名前：
Receive human-driven treatment planning
他の名前：
Receive RapidPlan treatment planning
他の名前：
|
|
実験的：Arm B (RapidPlan treatment planning, radiation therapy)
Patients receive RapidPlan treatment planning and undergo radiation therapy over 15-30 minutes on 5-44 fractions per standard of care. Additionally, patients undergo MRI pre-treatment and blood sample collection and PET throughout study. |
Undergo blood sample collection
他の名前：
Undergo MRI
他の名前：
Ancillary studies Undergo PET
他の名前：
Undergo radiation therapy
他の名前：
Receive human-driven treatment planning
他の名前：
Receive RapidPlan treatment planning
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Incidence of grade 3 or higher genitourinary (GU) and gastrointestinal (GI) adverse events (AEs)
時間枠：Up to 3 months post-radiotherapy
|
AEs will be defined using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Comparisons between treatment arms will be made using a non-inferiority test for the difference between two proportions with an alpha level of 5%. The proportion of patients experiencing grade 3 or higher GU or GI AEs over the number of patients eligible for toxicity will be estimated. |
Up to 3 months post-radiotherapy
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Nathan Y. Yu, MD、Mayo Clinic
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- GMROA2451
- GMROA2451 (その他の識別子：Mayo Clinic Radiation Oncology)
- NCI-2024-07870 (レジストリ識別子：CTRP (Clinical Trial Reporting Program))
- 24-006449 (その他の識別子：Mayo Clinic Institutional Review Board)
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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