NCT04776889

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 23, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 2, 2021

Completed
Last Updated

March 2, 2021

Status Verified

February 1, 2021

Enrollment Period

2 years

First QC Date

February 23, 2021

Last Update Submit

February 25, 2021

Conditions

Prostate Cancer Metastatic

Keywords

Prostate cancerRosuvastatinCastration/Androgen deprivationHMG-CoA ReductaseLipid metabolism/SurvivalAldoketoreductase 1C4Prostate specific antigenAlkaline phosphataseCaveolin-1ABCA-1SLDL-RP1Lipid profileepidermal growth factor receptor

Outcome Measures

Primary Outcomes (9)

  • Lipid profile

    effect of adding rosuvastatin to surgical castration on the lipid profile (LDL, triglycerides, cholesterol, HDL) in mg/dl

    6 months

  • Aggressiveness parameters

    effect of adding rosuvastatin to surgical castration on the PSA in ng/ml

    6 months

  • Aggressiveness parameters

    effect of adding rosuvastatin to surgical castration on the ALP in IU/L

    6 months

  • Aggressiveness parameters

    effect of adding rosuvastatin to surgical castration on the EGFR in ng/ml

    6 months

  • Aggressiveness parameters

    effect of adding rosuvastatin to surgical castration on the Caveolin-1 in pg/ml

    6 months

  • Lipid metabolism parameters

    effect of adding rosuvastatin to surgical castration on HMG-CoA reductase in ng/ml

    6 months

  • Lipid metabolism parameters

    effect of adding rosuvastatin to surgical castration on SLDLRP1 in pg/ml

    6 months

  • Lipid metabolism parameters

    effect of adding rosuvastatin to surgical castration on AKR1C4 ng/L

    6 months

  • Lipid metabolism parameters

    effect of adding rosuvastatin to surgical castration on ABCA-1 in pg/ml

    6 months

Secondary Outcomes (2)

  • short-term clinical outcome

    18 months

  • short-term clinical outcome

    18 months

Study Arms (2)

Control/statin non-users

ACTIVE COMPARATOR

newly diagnosed metastatic prostate cancer patients who underwent surgical castration in the form of bilateral subcapsular orchiectomy.

Procedure: surgical castration

Interventional/statin users

EXPERIMENTAL

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

Interventions

Rosuvastatin 20mgDRUG

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

Interventional/statin users
surgical castrationPROCEDURE

bilateral subcapsular orchiectomy

Control/statin non-users

Eligibility Criteria

Age50 Years - 85 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Naïve newly diagnosed with metastatic prostate cancer
  • Age ≥ 50 years.
  • No psychological or geographical barriers for regular follow up of the patients.

You may not qualify if:

  • Age \< 50 years.
  • psychological or geographical barriers for regular follow up of the patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cancer Institute

Cairo, 112796, Egypt

Location

Related Publications (1)

  • Karkeet RM, Zekri AN, Sayed-Ahmed MM, Sherif GM, Salem SE, Abdelbary A, Fouad MA, Saad SY. The prognosis of lipid reprogramming with the HMG-CoA reductase inhibitor, rosuvastatin, in castrated Egyptian prostate cancer patients: Randomized trial. PLoS One. 2022 Dec 8;17(12):e0278282. doi: 10.1371/journal.pone.0278282. eCollection 2022.

    PMID: 36480560DERIVED

MeSH Terms

Conditions

Prostatic NeoplasmsHypoalphalipoproteinemias

Interventions

Rosuvastatin CalciumCastration

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesHypolipoproteinemiasLipid Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsEndocrine Surgical ProceduresSurgical Procedures, OperativeUrogenital Surgical Procedures

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

February 23, 2021

First Posted

March 2, 2021

Study Start

January 15, 2019

Primary Completion

December 30, 2020

Study Completion

December 30, 2020

Last Updated

March 2, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will share

requests for individual participant data should be directed to riham.karkeet@nci.cu.edu.eg, and shall not be limited to specific institutes/researchers

Shared Documents
STUDY PROTOCOL, SAP, ICF, 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

Locations

EG(1)