2分割でMR-Linacを使用した前立腺放射線治療における線量段階的減量 (DESTINATION 2)
MR-Linacを用いた前立腺放射線治療における2分割での用量デスケーリング
The goal of this clinical trial is to find out whether lowering the radiation dose to parts of the prostate without visible tumor on MRI can reduce side effects while still effectively treating prostate cancer in men with low or intermediate-risk prostate cancer.
The main questions it aims to answer are:
- Does reducing the radiation dose to healthy prostate tissue lower the risk of bowel and urinary side effects?
- Can we maintain good cancer control by keeping a high dose for MRI-visible tumor areas?
Researchers will compare two treatment approaches:
- One group receives a uniform high dose to the entire prostate.
- The other group receives a lower dose to healthy prostate tissue and a high dose only to visible tumor areas.
Participants will:
- Receive two sessions of MRI-guided radiotherapy using an MR-Linac.
- Complete questionnaires about urinary, bowel, and sexual health before and after treatment.
- Have follow-up visits to monitor side effects and PSA levels for up to 2 years.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
研究の種類
研究の種類
入学 (推定)
入学
段階
段階
- 適用できない
連絡先と場所
研究連絡先
研究連絡先
- 名前：Floris Pos, MD, PhD
- 電話番号：+31205129111
- メール：f.pos@nki.nl
研究場所
-
-
-
Amsterdam、オランダ、1066CX
- 募集
- The Netherlands Cancer Institute
-
コンタクト：
- Floris Pos, MD, PhD
- 電話番号：+31205129111
- メール：f.pos@nki.nl
-
コンタクト：
-
-
参加基準
適格基準
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:
- Men aged ≥18 years
- Histological confirmation of prostate adenocarcinoma requiring radical radiotherapy
- Gleason score 3+3, 3+4 or 4+3 (ISUP Grade groups (GG) 1, 2 or 3)
- MRI-visible tumour(s) of PIRADS v2 grade 3 or higher and able to be delineated on T2 and diffusion-weighted imaging +/- dynamic contrast-enhanced imaging. Tumour nodule visible on MRI should be considered able to be boosted by treating clinician and <2.5cm in maximal dimension. MRI must be performed within 3 months of trial entry
- The MRI-defined lesion must be confirmed as malignant on biopsies (any Gleason grade is sufficient as long as Gleason score is reported).
- MRI stages mT1 and T2 or mT3a with ≤ 1mm tumour outside gland AND otherwise favourable intermediate risk characteristics (Gleason 3+3, 3+4)(as staged by AJCC TNM 2018)
- PSA <20 ng/ml prior to starting androgen deprivation therapy (ADT).
- WHO Performance status 0-2
- Ability of the participant to understand and the willingness to sign a written informed consent (IC) form.
- Ability/willingness to comply with the patient reported outcome questionnaires schedule throughout the study.
Exclusion Criteria:
- Contraindications to MRI (e.g. pacemaker, potentially mobile metal implant, claustrophobia)
- IPSS Score > 19
- High grade disease (GG3) occult to MRI-defined lesion. As a guide, any pathology for which you would consider surveillance is allowed outside of the MRI-defined area.
- Prostate volume >90cc
- Comorbidities which predispose to significant toxicity (e.g. inflammatory bowel disease) or preclude long term follow up
- Hip replacement, or other pelvic metalwork which causes artefact on diffusion-weighted imaging
- Previous pelvic radiotherapy
- Patients needing >6 months of ADT due to disease parameters.
- Previous invasive malignancy within the last 2 years excluding basal or squamous cell carcinomas of the skin, low risk non-muscle invasive bladder cancer (assuming cystoscopic follow up now negative) or small renal masses on surveillance.
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）
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
他の：均一線量SBRT
|
27 Gy dose in 2 fractions to the whole prostate+/- seminal vesicles with a 0mm PTV margin using MR-linac |
|
他の：デエスカレート線量SBRT
|
The benign prostate +/- SV CTV will receive 20 Gy in 2 fractions with a 0mm PTV margin using MR-linac. The intraprostatic tumor masses (on MRI) will receive 27 Gy in 2 fractions. A 4mm GTV to PTV margin will be added to the in-traprostatic MR visible tumour to form PTV 27Gy. |
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Acute GU toxicity
時間枠：within 13 weeks of starting radiotherapy
|
Physician-reported acute Grade 2 or higher CTCAE GU toxicity observed within 13 weeks of starting radiotherapy |
within 13 weeks of starting radiotherapy
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Dosimetry
時間枠：During Radiotherapy treatment of 8 days
|
Estimate the accumulated dose differences between treatment arms in terms of dose to prostate CTV, rectum, urethra and bladder |
During Radiotherapy treatment of 8 days
|
|
Late GI toxicity
時間枠：1 and 2 years after radiotherapy treatment
|
Physician reported late GI toxicity according to CTCAE v5.0 |
1 and 2 years after radiotherapy treatment
|
|
Biochemical relapse-free survival
時間枠：2 years
|
Assess biochemical relapse-free survival for 2 years |
2 years
|
|
Severity of erectile dysfunction experienced by patient
時間枠：Before radiotherapy treatment, and at 6, 12 and 24 months after radiotherapy treatment
|
The IIEF-5 patient reported outcomes (PROs) assess the acute severity of erectile dysfunction |
Before radiotherapy treatment, and at 6, 12 and 24 months after radiotherapy treatment
|
|
Acute GI toxicity
時間枠：At baseline, after the last fraction, and 2, 4 and 12 weeks after radiotherapy treatment
|
Physician reported acute GI toxicity according to CTCAE v5.0 |
At baseline, after the last fraction, and 2, 4 and 12 weeks after radiotherapy treatment
|
|
Late GU toxicity
時間枠：1 and 2 years after radiotherapy treatment
|
Physician reported late GU toxicity according to CTCAE v5.0 |
1 and 2 years after radiotherapy treatment
|
|
Late sexual toxicity
時間枠：1 and 2 years after radiotherapy treatment
|
Physician reported late sexual toxicity according to CTCAE v5.0 |
1 and 2 years after radiotherapy treatment
|
|
Severity of urinary symptoms (GU) experienced by patient
時間枠：Before radiotherapy treatment, after the last fraction, at 2, 4 and 12 weeks post-treatment, and at 6, 12 and 24 months after radiotherapy treatment
|
The patient reported outcomes (PROs) International Prostate Symptoms Score (IPSS) assess the severity of urinary symptoms what the patient experiences |
Before radiotherapy treatment, after the last fraction, at 2, 4 and 12 weeks post-treatment, and at 6, 12 and 24 months after radiotherapy treatment
|
|
Health-related quality of life experienced by patient
時間枠：Before start radiotherapy, week 4 and week 12, at 6, 12 and 24 months after radiotherapy treatment.
|
The EPIC-26 patient reported outcomes (PROs) assess the health-related quality of life |
Before start radiotherapy, week 4 and week 12, at 6, 12 and 24 months after radiotherapy treatment.
|
協力者と研究者
協力者
協力者
研究記録日
主要日程の研究
研究開始 (実際)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
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
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
その他の研究ID番号
- M24DTI
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
It is intended that data will be shared within the MOMENTUM collaboration, between centres delivering treatment in the same way as DESTINATION2. Pseudonymised data will be stored within MOMENTUM for at least 5 years. Storage will be cloud based and as the treating centre we will have free access to the data and control over who else can assess it.
IPD 共有時間枠
5 years
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
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。