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 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202311880225067 Date of Approval: 21/11/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title A comparative analysis of bilateral subcapsular orchidectomy and bilateral total orchidectomy in evaluating castration timeline in prostate cancer subjects
Official scientific title Bilateral subcapsular orchidectomy vs bilateral total orchidectomy: assessment of the castration timeline in patients with prostate cancer
Brief summary describing the background and objectives of the trial BACKGROUND: Prostate cancer (CaP) is a global health burden, the most frequent urological malignancy, and the second commonest malignancy in men worldwide. People in developing countries tend to present late, making androgen deprivation therapy the first line of management, which can be medical or surgical castration. Bilateral total orchidectomy has been commonly practiced. However, subcapsular orchidectomy has been said to show a similar outcome. OBJECTIVE: To assess the castration timeline of patients undergoing bilateral subcapsular orchidectomy and bilateral total orchidectomy. METHODOLOGY: A prospective comparative hospital-based study, over one year, will be carried out. Participants who consented will be randomized into two groups. One group will be offered bilateral subcapsular orchidectomy while the other group will be offered bilateral total orchidectomy. A preoperative blood sample will be obtained from the participants. Postoperative samples will be collected at 30-minute intervals, from 30 minutes post-op to 3 hours post-op. The samples will be centrifuged, separated, and stored at -80⁰C. Testosterone assay will be carried out using the AccuBind ELISA kit. Sociodemographic variables, clinical parameters, and laboratory results will be recorded in aa proforma. Collated samples will be analyzed using the IBM SPSS statistics version 27, and results will be presented in charts, figures, and tables.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) CASTTIME TRIAL
Disease(s) or condition(s) being studied Cancer,Surgery,Urological and Genital Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 01/12/2023
Actual trial start date
Anticipated date of last follow up 01/12/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 66
Actual target sample size (number of participants)
Recruitment status Active, not recruiting
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 Central randomisation by phone/fax Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group BILATERAL SUBCAPSULAR GROUP or BSO GROUP A preoperative blood sample will be obtained from the participants. Postoperative samples will be collected at 30-minute intervals, from 30 minutes post-op to 3 hours post-op for testosterone assay. In the BSO technique, a longitudinal incision will be made on the tunica albuginea (TA) to expose the testicular parenchyma. The testicular parenchyma will be peeled off from the TA with wet gauze. Hemostasis will be secured and TA closed. The scrotal wall will be closed in layers and a compression dressing will be applied for scrotal support 33
Control Group BILATERAL TOTAL ORCHIDECTOMY GROUP OR BTO GROUP A preoperative blood sample will be obtained from the participants. Postoperative samples will be collected at 30-minute intervals, from 30 minutes post-op to 3 hours post-op for testosterone assay. For the BTO technique, the spermatic cord structures will be divided between clamps, and the stump will be suture-ligated. The scrotal wall will be closed in layers and a compression dressing will be applied for scrotal support 33 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patient with clinical, laboratory and radiologic features and histologically diagnosed prostate cancer Patients with no histopathologic confirmation of prostate cancer. Patients with prostate cancer who are on any form of prostate cancer androgen ablation therapy (GnRH agonist, stilboestrol, or antiandrogen). Patients with chronic liver disease. Any patient with clinical ultrasonic or radiologic features of tumour other than prostate cancer 80 and over: 80+ Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 50 Year(s) 89 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 10/07/2023 ETHICS AND RESEARCH COMMITTEE OAUTHC
Ethics Committee Address
Street address City Postal code Country
ILESA ROAD IFE 220101 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To compare the effectiveness of the two techniques in inducing castration 30 minutes, and 1, 2, 3 hours post-operative period respectively
Secondary Outcome To assess the rate of fall of serum testosterone in the two study groups 30 minutes, and 1, 2, 3 hours post-op
Secondary Outcome To assess the hemodynamic status of the subjects at the immediate post operative state 30 minutes, and 1, 2, 3 hours post-op
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
OBAFEMI AWOLOWO UNIVERSITY TEACHING HOSPITALS COMPLEX ILESA ROAD IFE 220101 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
ELIBOH MONDAY DEPARTMENT OF SURGERY OAUTHC IFE 220101 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor ELIBOH MONDAY DEPARTMENT OF SURGERY OAUTHC IFE 220101 Nigeria SELF FUNDED
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator MONDAY ELIBOH osazemonday@gmail.com +2348138289832 DEPARTMENT OF SURGERY, OAUTHC, ILESA ROAD
City Postal code Country Position/Affiliation
IFE 220101 Nigeria SENIOR REGISTRAR UROLOGY TRAINEE
Role Name Email Phone Street address
Public Enquiries PEACE ASIKA peaceka92@gmail.com +2348134632746 DEPARTMENT OF SURGERY, OAUTHC
City Postal code Country Position/Affiliation
IFE 220101 Nigeria SCIENTIFIC OFICER
Role Name Email Phone Street address
Scientific Enquiries TAJUDEEN BADMUS akintab@yahoo.com +2348024786397 UROLOGY UNIT, OAUTHC
City Postal code Country Position/Affiliation
IFE 220101 Nigeria CHIEF UROLOGIST
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Independent participant data collected during the trial, will be made available after deidentification Informed Consent Form,Statistical Analysis Plan,Study Protocol Open Open
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information