Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202102664354163 Date of Registration: 24/02/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The Prognosis of Lipid Reprogramming with Rosuvastatin, in Castrated Egyptian Prostate Cancer Patients
Official scientific title The Prognosis of Lipid Reprogramming with the HMG-CoA Reductase Inhibitor, Rosuvastatin, in Castrated Egyptian Prostate Cancer Patients
Brief summary describing the background and objectives of the trial The current study has been initiated to investigate, on mechanism-based, the possible therapeutic effects of rosuvastatin when combined with androgen deprivation in metastatic prostate cancer patients. 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 patients.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cancer
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 01/01/2019
Actual trial start date 15/01/2019
Anticipated date of last follow up 31/12/2020
Actual Last follow-up date 31/12/2020
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants) 70
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Rosuvastatin 20 mg/day 6 months surgically castrated metastatic prostate cancer participants were prescribed rosuvastatin 20 mg/day for 6 months 40
Control Group surgical castration life long surgical castration 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Naïve newly diagnosed with metastatic prostate cancer Age ≥ 50 years No psychological or geographical barriers for regular follow up of the patients. Age < 50 years psychological or geographical barriers for regular follow up of the patients. 80 and over: 80+ Year,Aged: 65 Year(s)-79 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 50 Year(s) 85 Year(s) Male
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 14/01/2019 Institutional Review Board of the National Cancer Institute
Ethics Committee Address
Street address City Postal code Country
Kasr Al-Aini Street, Fom Elkalig, Cairo, Egypt Cairo 112796 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome assess the effect of rosuvastatin addition to surgical castration in metastatic prostate cancer patients by measuring the lipid profile parameters, lipid metabolism related parameters and prostate cancer aggressiveness parameters baseline, 3 and 6 months
Secondary Outcome Assess the effect of rosuvastatin addition to surgical castration in metastatic prostate cancer patients on the clinical outcome in terms of disease progression and overall survival 6 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
National Cancer Institute Cairo University Kasr Al-Aini Street, Fom Elkalig Cairo 112796 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Cairo University Cairo University Rd Cairo 12613 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor National Cancer Institute Cairo University Kasr Al-Aini Street, Fom Elkalig, Cairo, Egypt Cairo 112796 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Abdelrahman Zekri Kasr Al Eini Street Cairo 112796 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Sherif Saad sherifibrahem@yahoo.co.uk 01280296851 Kasr Al-Aini Street, Fom Elkalig, Cairo, Egypt
City Postal code Country Position/Affiliation
Cairo 112796 Egypt Head of Cancer Biology Department National Cancer Institute Cairo University
Role Name Email Phone Street address
Scientific Enquiries Riham Karkeet riham.karkeet@nci.cu.edu.eg 01220112453 Kasr Al-Aini Street, Fom Elkalig, Cairo, Egypt
City Postal code Country Position/Affiliation
Cairo 112796 Egypt National Cancer Institute Cairo University
Role Name Email Phone Street address
Public Enquiries Riham Karkeet riham.karkeet@nci.cu.edu.eg 01220112453 Kasr Al-Aini Street, Fom Elkalig, Cairo, Egypt
City Postal code Country Position/Affiliation
Cairo 112796 Egypt National Cancer Institute Cairo University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual Participant Data will be available upon request. Requests should be directed to riham.karkeet@nci.cu.edu.eg and will be sent by email to the requesting party. Data sharing will by anonymous to protect participants' privacy. Available data include raw data, consent form, and statistical methodology. Informed Consent Form,Statistical Analysis Plan,Study Protocol For 2 years after publication. Requests for participant data should be directed to riham.karkeet@nci.cu.edu.eg, and shall not be limited to specific institutes/researchers.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 18/02/2021
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 18/02/2021 Result - 15/03/2021
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information