The Prognosis of Lipid Reprogramming With Rosuvastatin, in Castrated Egyptian Prostate Cancer Patients
The Prognosis of Lipid Reprogramming With the HMG-CoA Reductase Inhibitor, Rosuvastatin, in Castrated Egyptian Prostate Cancer Patients
Aim: The role of surgical castration and rosuvastatin treatment on lipid profile and lipid metabolism related markers was evaluated for their prognostic significance in metastatic prostate cancer (mPC) patients.
Methods: A total of 70 newly diagnosed castrated mPC patients treated with castration were recruited and divided into two groups: Group I included 30 patients and served as control (statin non-users) while group II included 40 patients treated with Rosuvastatin (20 mg/day) for 6 months and served as statin users. Prostate specific antigen (PSA), epidermal growth factor receptor (EGFR), Caveolin-1, lipid profile (LDL, HDL, triglycerides and cholesterol) and lipid metabolism related markers (aldoketoreductase (AKR1C4), HMGCoA reductase, ABCA1, and SLDL RP1) were measured at baseline, after 3 and 6 months. Overall survival (OS) were analyzed by Kaplan-Meier and COX regression for prognostic significance.
調査の概要
詳細な説明
This prospective randomized controlled study was conducted at the National Cancer Institute (NCI), Cairo University. The study ID BB1901-30303 was approved by the Institutional Human Research Ethics Committee of NCI, Egypt, Number 00004025, with IRB review Number 201819019.3 and conducted in accordance with the Declaration of Helsinki with informed consent was taken from all participants. The study included 70 Egyptian metastatic prostate cancer (m PC) patients who were treated and followed up in the NCI hospital in the period from January 2019 till December 2020. Patients were recruited from January to June 2019, then followed-up to December 2020.
Blood samples were withdrawn from all patients at baseline to monitor parameters under investigation. Then, all patients were subjected to surgical castration and divided in to two groups. Group I included 30 patients and served as control (statin non-users). Group II included 40 patients treated with Rosuvastatin (20 mg/day) for 6 months and served as statin users. Then, blood samples were withdrawn from the two groups after 3 and 6 months. Full demographic information and clinicopatholologic characteristics were obtained for each patient including; age, comorbid diseases, initial complain symptoms, family history of malignancy, smoking status and performance status. Also, serum level of prostate specific antigen (PSA) and alkaline phosphatase (ALP), Gleason score and metastasis sites were recorded. The treatment modality and decision making were according to NCI guidelines.
Collected whole blood samples into k.EDTA tubes were incubated at room temperature for 15 minutes and then centrifuged for 20 minutes at 1500 rpm. The plasma supernatant was carefully collected and freezed until analysis. Plasma protein concentrations of some lipid reprogramming and prostate cancer aggressiveness markers were measured. Kits were probed against human soluble low density lipoprotein receptor related protein -1 (SLDLRP-1; catalogue number: SL2705Hu), human ATP binding cassette transporter A-1 (ABCA-1; catalogue number: SL0314Hu), Human Aldoketo-reductase family 1 member C4 (AKR-1C4; catalogue number: SL3032Hu), human 3-hydroxy-3-methylglutaryl Co-enzyme A reductase (HMGCR; catalogue number: SL3030Hu), human epidermal growth factor receptor (EGFR; catalogue number: SL0665Hu) and human Caveolin-1 (Cav-1; catalogue number: SL0427Hu). Procedures were carried out in accordance with the manufacturer's instructions. The concentration of the markers in plasma samples was calculated by comparing the OD of the samples to the corresponding plotted standard curves.
Data management and statistical analysis were performed using The Statistical Package for Social Sciences (SPSS) version 24. Normal distribution and variance homogeneity of data were assessed using the Kolmogorov-Smirnov and Levene's tests, respectively. Numerical data were summarized using median and interquartile range (IQR). Categorical data were summarized as count and percentage. Patients were stratified according to their clinicopathological factors and for more than two subgroups of patients, the change in measured parameters were tested for significance using Kruskal-Wallis test and the pairwise comparison were done using Mann-Whitney. The change in proteins concentration over time was tested using Friedman test of significance. Spearman correlation analysis was used to test all possible correlations. Kaplan- Meier survival analysis was used to calculate the cumulative survival rate as well as median levels of OS after two years of follow up. OS was calculated from date of diagnosis to date of death by any cause. Living patients or patients lost to follow-up were censored on the last known alive date. The hazardous effect of death or progression Cox proportion hazard Model was used to evaluate the hazardous effect of different clinicopathological and proteins levels on death and progression. All P-values are two-sided. P-values < 0.05 were considered significant.
研究の種類
入学 (実際)
段階
- フェーズ 4
連絡先と場所
研究場所
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Cairo、エジプト、112796
- National Cancer Institute
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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
説明
Inclusion Criteria:
- Naïve newly diagnosed with metastatic prostate cancer
- Age ≥ 50 years.
- No psychological or geographical barriers for regular follow up of the patients.
Exclusion Criteria:
- Age < 50 years.
- psychological or geographical barriers for regular follow up of the patients.
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:Control/statin non-users
newly diagnosed metastatic prostate cancer patients who underwent surgical castration in the form of bilateral subcapsular orchiectomy.
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bilateral subcapsular orchiectomy
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実験的:Interventional/statin users
newly diagnosed metastatic prostate cancer patients who underwent surgical castration in the form of bilateral subcapsular orchiectomy and administered rosuvastatin 20 mg/day for 6 months
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Rosuvastatin 20mg/day for 6 months added to bilateral subcapsular orchiectomy
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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 |
---|---|---|
Lipid profile
時間枠:6 months
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effect of adding rosuvastatin to surgical castration on the lipid profile (LDL, triglycerides, cholesterol, HDL) in mg/dl
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6 months
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Aggressiveness parameters
時間枠:6 months
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effect of adding rosuvastatin to surgical castration on the PSA in ng/ml
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6 months
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Aggressiveness parameters
時間枠:6 months
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effect of adding rosuvastatin to surgical castration on the ALP in IU/L
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6 months
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Aggressiveness parameters
時間枠:6 months
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effect of adding rosuvastatin to surgical castration on the EGFR in ng/ml
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6 months
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Aggressiveness parameters
時間枠:6 months
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effect of adding rosuvastatin to surgical castration on the Caveolin-1 in pg/ml
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6 months
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Lipid metabolism parameters
時間枠:6 months
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effect of adding rosuvastatin to surgical castration on HMG-CoA reductase in ng/ml
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6 months
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Lipid metabolism parameters
時間枠:6 months
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effect of adding rosuvastatin to surgical castration on SLDLRP1 in pg/ml
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6 months
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Lipid metabolism parameters
時間枠:6 months
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effect of adding rosuvastatin to surgical castration on AKR1C4 ng/L
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6 months
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Lipid metabolism parameters
時間枠:6 months
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effect of adding rosuvastatin to surgical castration on ABCA-1 in pg/ml
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6 months
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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 |
---|---|---|
short-term clinical outcome
時間枠:18 months
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disease progression/regression
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18 months
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short-term clinical outcome
時間枠:18 months
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overall survival
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18 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 (実際)
研究の完了 (実際)
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
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- CB1901-30303
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
IPD 共有時間枠
IPD 共有アクセス基準
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
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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surgical castrationの臨床試験
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