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The Prognosis of Lipid Reprogramming With Rosuvastatin, in Castrated Egyptian Prostate Cancer Patients

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ClinicalTrials.gov Identifier: NCT04776889
Recruitment Status : Completed
First Posted : March 2, 2021
Last Update Posted : March 2, 2021
Sponsor:
Information provided by (Responsible Party):
Riham Karkeet, National Cancer Institute, Egypt

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Prostate Cancer Metastatic Drug: Rosuvastatin 20mg Procedure: surgical castration Phase 4

Detailed Description:

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Blood samples were withdrawn from all patients at baseline to monitor parameters under investigation.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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A cohort of 70 newly diagnosed metastatic prostate cancer patients were recruited. 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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Prognosis of Lipid Reprogramming With the HMG-CoA Reductase Inhibitor, Rosuvastatin, in Castrated Egyptian Prostate Cancer Patients
Actual Study Start Date : January 15, 2019
Actual Primary Completion Date : December 30, 2020
Actual Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Active Comparator: Control/statin non-users
newly diagnosed metastatic prostate cancer patients who underwent surgical castration in the form of bilateral subcapsular orchiectomy.
Procedure: surgical castration
bilateral subcapsular orchiectomy

Experimental: 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
Drug: Rosuvastatin 20mg
Rosuvastatin 20mg/day for 6 months added to bilateral subcapsular orchiectomy




Primary Outcome Measures :
  1. Lipid profile [ Time Frame: 6 months ]
    effect of adding rosuvastatin to surgical castration on the lipid profile (LDL, triglycerides, cholesterol, HDL) in mg/dl

  2. Aggressiveness parameters [ Time Frame: 6 months ]
    effect of adding rosuvastatin to surgical castration on the PSA in ng/ml

  3. Aggressiveness parameters [ Time Frame: 6 months ]
    effect of adding rosuvastatin to surgical castration on the ALP in IU/L

  4. Aggressiveness parameters [ Time Frame: 6 months ]
    effect of adding rosuvastatin to surgical castration on the EGFR in ng/ml

  5. Aggressiveness parameters [ Time Frame: 6 months ]
    effect of adding rosuvastatin to surgical castration on the Caveolin-1 in pg/ml

  6. Lipid metabolism parameters [ Time Frame: 6 months ]
    effect of adding rosuvastatin to surgical castration on HMG-CoA reductase in ng/ml

  7. Lipid metabolism parameters [ Time Frame: 6 months ]
    effect of adding rosuvastatin to surgical castration on SLDLRP1 in pg/ml

  8. Lipid metabolism parameters [ Time Frame: 6 months ]
    effect of adding rosuvastatin to surgical castration on AKR1C4 ng/L

  9. Lipid metabolism parameters [ Time Frame: 6 months ]
    effect of adding rosuvastatin to surgical castration on ABCA-1 in pg/ml


Secondary Outcome Measures :
  1. short-term clinical outcome [ Time Frame: 18 months ]
    disease progression/regression

  2. short-term clinical outcome [ Time Frame: 18 months ]
    overall survival



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04776889


Locations
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Egypt
National Cancer Institute
Cairo, Egypt, 112796
Sponsors and Collaborators
National Cancer Institute, Egypt
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Responsible Party: Riham Karkeet, Assistant lecturer, National Cancer Institute, Egypt
ClinicalTrials.gov Identifier: NCT04776889    
Other Study ID Numbers: CB1901-30303
First Posted: March 2, 2021    Key Record Dates
Last Update Posted: March 2, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: requests for individual participant data should be directed to riham.karkeet@nci.cu.edu.eg, and shall not be limited to specific institutes/researchers
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: for 2 years after publication
Access Criteria: requests for participant data should be directed to riham.karkeet@nci.cu.edu.eg, and shall not be limited to specific institutes/researchers

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Riham Karkeet, National Cancer Institute, Egypt:
Prostate cancer
Rosuvastatin
Castration/Androgen deprivation
HMG-CoA Reductase
Lipid metabolism/
Survival
Aldoketoreductase 1C4
Prostate specific antigen
Alkaline phosphatase
Caveolin-1
ABCA-1
SLDL-RP1
Lipid profile
epidermal growth factor receptor
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors