- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04776889
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.
연구 개요
상세 설명
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Blood samples were withdrawn from all patients at baseline to monitor parameters under investigation.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 Then, blood samples were withdrawn from the two groups after 3 and 6 months.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.
연구 유형
등록 (실제)
단계
- 4단계
연락처 및 위치
연구 장소
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Cairo, 이집트, 112796
- National Cancer Institute
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
활성 비교기: 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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실험적: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Lipid profile
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
short-term clinical outcome
기간: 18 months
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disease progression/regression
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18 months
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short-term clinical outcome
기간: 18 months
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overall survival
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18 months
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- CB1901-30303
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 기간
IPD 공유 액세스 기준
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
- CSR
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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