Adaptive Radiotherapy for High-risk Prostate Cancer Using Multiparametric MRI (ARPC-MRI)
Adaptive Radiotherapy for High-risk Prostate Cancer Using Multiparametric MRI (ARPC-MRI) - a Feasibility Study
調査の概要
状態
条件
詳細な説明
Mount Vernon Cancer Centre at East and North Hertfordshire NHS Trust offers patients with certain cancers a treatment called adaptive radiotherapy. The aim of adaptive radiotherapy is to respond to physical changes that occur during treatment to ensure the radiation continues to be directed at the cancer and to minimise the amount of healthy tissue treated. For example, if tumour shrinkage or weight loss occurs during head and neck radiotherapy the patient may have a repeat CT scan and a new radiotherapy treatment plan after a few weeks of treatment. For patients with cancer of the bladder or cervix changes in bladder and uterus size and position can be predicted allowing the prospective creation of three radiotherapy treatment plans, each day the best fitting plan, i.e. the one that closely covers the tumour whilst giving minimal dose to normal tissues, is selected and used for treatment, this is known as plan-of-the-day adaptive radiotherapy.
Small changes in shape and position of the prostate occur but are generally the result of rectal changes which cannot be predicted, consequently adaptive radiotherapy based on physical change is not possible for prostate cancer treatments. However, recent literature suggests that magnetic resonance imaging (MRI) can detect changes within the prostate in response to radiotherapy, some studies have seen changes as early as the second week of radiotherapy treatment. A feasibility study to investigate if these changes can support radiotherapy treatment plan adaption for prostate cancer treatments is proposed, whether the plan can be adapted to give a higher treatment dose to any areas of the prostate that show poor response to radiotherapy without increasing bowel and bladder dose is of particular interest. The treatment for patients who participate in the study would not be changed but the results may help to personalise and improve the treatment of future patients.
研究の種類
入学 (予想される)
連絡先と場所
研究場所
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Middlesex
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Northwood、Middlesex、イギリス、HA6 2RN
- 募集
- East and North Hertfordshire NHS Trust
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コンタクト:
- Roberto Alonzi
- 電話番号:0203 826 2166
- メール:ralonzi@nhs.net
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コンタクト:
- Angela Turnbull
- 電話番号:02038262313
- メール:angelaturnbull@nhs.net
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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
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
New diagnosis of high-risk prostate cancer: any of:
- Gleason score of 8, 9 or 10
- PSA > 20
- T3/4
- Patient due to receive androgen deprivation therapy (ADT)
- Prescribed 78Gy/39# external beam radiotherapy
- Measurable dominant intraprostatic tumour on diagnostic imaging of at least 10mm diameter
- ≥18 years of age
- ECOG performance status of 0-1
- Informed, written and witnessed consent to participate is required.
Exclusion Criteria:
- Patients who are not due to receive androgen deprivation therapy (ADT)
- Any contraindication to MRI scanning including contraindication to MRI contrast agents
- Previous radiotherapy to the pelvis
- Any physical or social reasons that would make attendance for additional visits impossible.
- Any patient with or planned for prostate fiducial markers.
- Unable to give informed consent.
- Patients currently enrolled in an interventional clinical trial.
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
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 |
---|---|---|
Reproducability of DW-MRI
時間枠:7 months
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Apparent diffusion coefficient (ADC)
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7 months
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Reproducibility of DCE-MRI
時間枠:7 months
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Using volume transfer constant
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7 months
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Reproducibility of DCE-MRI
時間枠:7 months
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Using leakage space as a percentage of unit volume
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7 months
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Reproducibility of DCE-MRI
時間枠:7 months
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Using rate constant
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7 months
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MP-MRI Response Correlation
時間枠:7 months
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Developing methods to identify and delineate areas of tumour according to their response to radiotherapy treatment by correlating MP-MRI kinetic parameters with anatomical T2 MRI images
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7 months
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Assessment of adapted dosimetry
時間枠:After week 3 of radiotherapy
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Amount of acceptable radiotherapeutic dose
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After week 3 of radiotherapy
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Assessment of cell kill
時間枠:3 months
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Proportion of cells killed at given dose following androgen deprivation therapy
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3 months
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Tumour response prediction
時間枠:7 months
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Assess which proportion of tumours demonstrate areas of poor response that could benefit from adaptive radiotherapy
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7 months
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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 (実際)
一次修了 (予想される)
研究の完了 (予想される)
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。
前立腺がんの臨床試験
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