Quantitative mpMRI to Predict Metastatic Potential of Prostate Cancer (QmpMRI)
調査の概要
詳細な説明
Patients diagnosed with prostate cancer will likely not die from the primary tumor, but from (extended) metastatic disease. One of the first steps towards extended metastatic disease is the presence of lymph node metastases, which is an important factor in determining therapy and prognosis. Although historically all patients with lymph node metastases are considered incurable, research has shown that patients with only a limited number of small (<8 mm) nodal metastases have a better prognosis as compared to patients with more extensive involvement. In patients with only a limited number of small nodal metastases (oligo-metastatic), therapy with curative intent might be pursued, e.g. by surgical resection or loco-regional radiotherapy. With continuously improving opportunities to very selectively treat small numbers of metastatic sites it is of utmost importance to accurately diagnose the first signs of oligo-metastatic disease and to define its extent.
It is hypothesized that magnetic resonance imaging (MRI) can obtain more information from the local prostate than what is now used in the clinic to stage localized prostate cancer and oligo-metastatic disease. In recent years positron emission tomography (PET) in combination with computerized tomography (CT) and Prostate Specific Membrane Antigen (PSMA) tracers (PSMA-PET/CT) has emerged as an imaging modality to visualize (early) metastatic disease, but its accuracy in detecting oligo-metastatic spread is unknown, as small nodal metastases can be missed. In this study, the correlation is assessed between functional, quantitative and metabolic local tumor characteristics with PSMA-PET/CT-proven nodal involvement, to be able to predict metastatic potential from quantitative MRI parameters of the localized tumor. If the study shows potential for predicting presence of metastatic disease, future patients will benefit from improved nodal staging, potentially leading to more accurate and personalized treatment of the correct disease stage.
研究の種類
入学 (予想される)
連絡先と場所
研究連絡先
- 名前：Carlijn Tenbergen
- 電話番号：+31 24 36 52285
- メール：carlijn.tenbergen@radboudumc.nl
研究連絡先のバックアップ
- 名前：Tom Scheenen, Prof. Dr.
- 電話番号：+31 24 36 13157
- メール：tom.scheenen@radboudumc.nl
研究場所
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Nijmegen、オランダ
- Radboud university medical centre
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コンタクト：
- Carlijn Tenbergen
- メール：carlijn.tenbergen@radboudumc.nl
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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
Patients, diagnosed with prostate cancer by prostate biopsy and having a high risk of nodal metastases, will be recruited at the Radboudumc in Nijmegen. This research population will be a suitable reflection of the potential patient group who will eventually benefit from this new diagnostic mpMRI approach, in case the results match the hypothesis. Characteristics of this group will comprise all men with an expected age in the range of 50-75 years.
Patients will be informed about the ongoing study by their treating physician. Patients will receive the patient information folder and will be contacted by one of the researchers. Upon approval, informed consent paperwork will be handed.
説明
Inclusion Criteria:
- Histologically proven primary cancer of the prostate, based on prostate biopsy-core analysis.
- Patient is scheduled and fit for PSMA-PET/CT
- Age≥50 years. Ability to give voluntary written informed consent to participate in this study.
Exclusion Criteria:
- Contraindication for MRI-scanning, i.e. claustrophobia, intracranial metal clips, metallic bodies in the eye, implanted electric and electronic devices not eligible for MRI (pacemakers, insulin pumps, cochlear implants, neurostimulators).
- Prior prostate cancer treatment.
- Prior pelvic surgery, associated with pelvic lymphadenopathy
- Presence of any medical condition that in the opinion of the investigator/treating physician will affect patients' clinical status by participating in this trial.
- Inability to lie still for 45 minutes or comply with imaging.
- The patient is already enrolled in one or more concurrent studies, which could confound the results of this study, according to the investigators.
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
- 観測モデル：ケースのみ
- 時間の展望：見込みのある
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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optimal combination of quantitative MRI parameters that best correlates to the presence of (lymph node) metastases in prostate cancer as seen on PSMA-PET/CT.
時間枠：within 14 days of PSMA-PET/CT scan, before any therapy
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To find the optimal combination of quantitative parameters for discriminating between positive and negative PSMA-PET/CT, logistic regression modelling will be used.
The performance of the model will be evaluated using receiver operating characteristic curve analysis.
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within 14 days of PSMA-PET/CT scan, before any therapy
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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 |
|---|---|---|
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the performance of individual quantitative MRI parameters discriminating localized from (oligo-)metastatic disease
時間枠：within 14 days of PSMA-PET/CT scan, before any therapy
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To test the individual quantitative MRI parameters for a significant difference between localized and (oligo-)metastatic disease, non-parametric tests for independent groups (Mann-Whitney U test) will be used.
The ability of each parameter to discriminate between positive and negative PSMA-PET/CT is assessed using receiver operating characteristic curve analysis, which allows comparison to the logistic regression model performance.
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within 14 days of PSMA-PET/CT scan, before any therapy
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MR parameters that correlate to the amount of metastases as found on PSMA-PET/CT
時間枠：within 14 days of PSMA-PET/CT scan, before any therapy
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Participants with a positive PET/CT scan result will be divided in groups according to the number of positive lymph nodes detected (if variance within participants allows).
To test for significant differences between these groups for each of the quantitative parameters, the non-parametric tests for multiple independent groups (Kruskal Wallis) will be used.
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within 14 days of PSMA-PET/CT scan, before any therapy
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MR parameters that correlate to local prostate PSMA-PET intensity
時間枠：within 14 days of PSMA-PET/CT scan, before any therapy
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To test for a correlation between the quantitative parameters and the local prostate PSMA-PET intensity, a spearmans rho test for correlation between two continuous variables will be used.
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within 14 days of PSMA-PET/CT scan, before any therapy
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協力者と研究者
捜査官
- 主任研究者：Tom Scheenen、Radboud University Medical Center
研究記録日
主要日程の研究
研究開始 (予想される)
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
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