MICRO-ultrasound Guided Prostate SBRT (MICRO-S)
MICRO-ultrasound Guided Prostate SBRT (MICRO-S)
調査の概要
状態
条件
詳細な説明
Prostate cancer is one of the most common cancers in men, and many patients receive a treatment called external beam radiation therapy. This treatment usually works well, but in some men the cancer can return. Giving a higher dose of radiation to the whole prostate could lower this risk, but doing so can also cause more side effects to the bladder and bowel. Researchers have learned that cancer often comes back in specific spots inside the prostate called dominant intraprostatic lesions (DILs). If doctors can clearly see these areas, they may be able to safely give extra radiation just to those spots. A new type of imaging, called microultrasound (microUS), creates very detailed pictures of the prostate and may help doctors more accurately find these cancer areas.
This study will test whether it is safe and effective to use stereotactic body radiation therapy (SBRT)-a short, targeted form of radiation-together with a microUS-guided radiation boost to the cancerous spots inside the prostate. Researchers will compare treatment plans that use microUS to plans created using the current standard method, which relies on MRI images. By learning whether microUS can successfully guide targeted radiation, this research may help make advanced and more personalized prostate cancer treatment available to more patients.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Lucas Mendez, MD
- 電話番号：519-685-8500
- メール：Lucas.Mendez@lhsc.on.ca
研究場所
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Ontario
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London、Ontario、カナダ、N6A 5W9
- London Health Sciences Centre, Verspeeten Family Cancer Centre
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コンタクト：
- Lucas Mendez, MD
- 電話番号：519-685-8500
- メール：Lucas.Mendez@lhsc.on.ca
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-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Histologically confirmed carcinoma of the prostate (biopsy results with 12 months of enrollment)
- Intermediate risk as defined by NCCN criteria
- Conventional imaging (bone scan and abdominal pelvic computed tomography) is mandatory for NCCN unfavourable intermediate risk prostate cancer patients with PSA > 10. Negative nodal, skeletal or visceral metastases within 16 weeks of enrollment (for patients requiring staging). Alternatively, patients with no signs of extra-prostatic disease on PSMA-PET scans are also candidates for this trial
- ECOG performance status 0-1
- Willing to give informed consent to participate in this clinical trial
- Able and willing to complete QOL questionnaires Most responsive physician definition if androgen deprivation therapy will be used (only allowed for NCCN unfavourable intermediate risk prostate cancer)
Exclusion Criteria:
- Estimated prostate volume > 60cc (volume based on transrectal ultrasound)
- Prior TURP
- Prior prostate cancer treatment, including 5-alpha reductase inhibitor treatment
- Low, high or very high-risk disease as per NCCN guidelines
- Connective tissue disease or inflammatory bowel disease
- Contraindication to prostate microUS
- Men with double hip prostheses
- Contraindication for MRI (i.e. non-compatible stent, pacemaker, prosthesis etc.)
- Anticoagulation medication (if unsafe to discontinue for fiducial marker insertion)
- Diagnosis of bleeding diathesis
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 |
|---|---|
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アクティブコンパレータ：CT-Guided, mpMRI Assisted Whole Prostate SBRT
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Standard whole prostate stereotactic body radiation therapy (40 Gray/5 fractions given on alternate days)
Micro-boost to the dominant intraprostatic lesions (DILs) of 40 Gray, with the rest of the prostate receiving 35 Gray.
If no DILs identified, whole prostate stereotactic body radiation therapy with dose of 35 Gray.
Both interventions to be given in 5 fractions on alternate days.
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実験的：CT-Guided Prostate SBRT with Microultrasound-Guided Dominant Intraprostatic Lesion Boost
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マイクロ超音波
Standard whole prostate stereotactic body radiation therapy (40 Gray/5 fractions given on alternate days)
Micro-boost to the dominant intraprostatic lesions (DILs) of 40 Gray, with the rest of the prostate receiving 35 Gray.
If no DILs identified, whole prostate stereotactic body radiation therapy with dose of 35 Gray.
Both interventions to be given in 5 fractions on alternate days.
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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 |
|---|---|---|
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Acute GU Toxicity Measured by Patient-Reported Outcomes in the Expanded Prostate Cancer Index (EPIC-26)
時間枠：From enrollment to 3 weeks after the end of treatment
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To evaluate if microUS-guided DIL boost with dose de-escalation to the remaining prostate results in superior acute GU patient-reported outcomes when compared to standard prostate SBRT, as measured by the Expanded Prostate Cancer Index (EPIC-26)
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From enrollment to 3 weeks after the end of treatment
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。