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.: PACTR202310737952361 Date of Approval: 19/10/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The Comparison between ultrasound guided Trans-perineal and Transrectal prostate needle biopsy in the Detection of Prostate Cancer: A prospective randomized study.
Official scientific title The Comparison between ultrasound guided Trans-perineal and Transrectal prostate needle biopsy in the Detection of Prostate Cancer: A prospective randomized study.
Brief summary describing the background and objectives of the trial Background Introduction: Prostate cancer (PCa), previously reported as relatively rare in Nigeria, is currently the leading cancer and leading cause of cancer-related death in Nigerian men. Prostate biopsy, being the cornerstone for confirming the diagnosis of PCa, has traditionally been performed through a transrectal approach, widely accepted as the gold standard. However, a significant number of urologists are moving towards a transperineal approach. Many studies carried out in the western world have shown evidence that Trans-Perineal Prostate Needle Biopsy (TP-PNB) has the advantage of reduced levels of post-procedure infection and are able to target anterior tumours, when compared to Trans- Rectal Prostate Needle Biopsy (TR PNB); however there is paucity of local studies. Aim and objectives: The aim of this study is to explore an efficient first-time biopsy scheme for detecting PCa, comparing TR-PNB vs TP-PNB approaches with TRUS guidance under Local Anaesthesia. The objectives will be to compare tissue yield/ cancer detection rate of TRUS guided TP and TR PNB under local anaesthesia. Methods: The study will be a coss-over design study to compare TP and TR PNB in 60 subjects presenting to Department of Surgery LASUTH on suspicion of PCa with one or combination of elevated Prostate-Specific Antigen (PSA) levels, abnormal Digital Rectal Examination (DRE), and suspicious trans-abdominal ultrasound scan findings. All will have 12-core extended needle biopsy done. Outcome in this study will be cancer detection rates. Data Analysis: All data obtained will be documented in a proforma. Data will be analyzed using SPSS version 26. Inferential statistics will be carried out using Chi square, independent student t-test and correlation. P-value <0.05 will be assumed as significant at 95% confidence level.
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 04/09/2023
Actual trial start date
Anticipated date of last follow up 02/08/2024
Actual Last follow-up date 03/07/2023
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
Recruitment status 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
Crossover: all participants receive all interventions in different sequence during study Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Transperineal prostate needle biopsy Not Applicable one off This will involve sampling the prostate gland using a core biopsy needle either via a transperineal approach to the prostate gland using a transrectal ultrasound guidance under local anaesthesia for the diagnosis of prostate cancer 60
Control Group TRUS guided Transrectal prostate needle biopsy under local anesthesia Not applicable One off This will involve sampling the prostate gland using a core biopsy needle via a transrectal approach to the prostate gland using TRUS guidance under local anaesthesia 60 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• All consenting adult males with positive DRE findings suggestive of PCa and elevated PSA levels > 4ng/ml. • Willingness to sign informed consent and adhere to the study protocol • Acute prostatitis within the last 6 months. • Current non-urologic bacterial infection requiring active treatment with antibiotics. • Unfit to undergo prostate biopsy under local anaesthesia. • Patients who were uraemic or had uncontrolled hypertension or bleeding diasthesis or patients on anticoagulants or antiplatelets medications. • Prior definitive therapy for prostate cancer, such as radiation therapy or partial gland ablation. • Patients who refused to participate in study. 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 40 Year(s) 90 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 19/09/2023 Health Research and Ethics Committee HREC
Ethics Committee Address
Street address City Postal code Country
1-5 Oba Akinjobi Way, Ikeja Lagos 101245 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Cancer detection rate 14 day post operatively
Secondary Outcome Pain score and tolerability Intraoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Lagos State University Teaching Hospital 1 - 2 Oba Akinjobi Street Ikeja GRA Lagos Lagos Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Akpo Ralph EDEWOR Department of Surgery, LASUTH 1-2 Oba Akinjobi Way, Ikeja Lagos 101245 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Akpo Ralph Edewor Department of Surgery, 1-2 Oba Akinjobi Way, Lagos Lagos 101245 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Akpo EDEWOR akporalph12@gmail.com 2348026406842 Department of Surgery, 1-2 Oba Akinjobi Way, Ikeja
City Postal code Country Position/Affiliation
Lagos 101245 Nigeria Senior Registrar
Role Name Email Phone Street address
Public Enquiries Clement AKINSOLA ceefourme@gmail.com 2348174226011 Department of Surgery, 1-2 Oba, Akinjobi Way, Lagos
City Postal code Country Position/Affiliation
Lagos 101245 Nigeria Researcher
Role Name Email Phone Street address
Scientific Enquiries Dayo Osisanya lasuthethics@gmail.com 2347030421672 HREC, LASUTH, 1-2 Oba Akinjobi Way, LASUTH
City Postal code Country Position/Affiliation
LAGOS 101245 Nigeria Ethical committe
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Study is still in progress. The Data generated from this study will be used only for the sole purpose of the dissertation for the partial fulfilment of the requirement of the award of final fellowship of the west Africa College of Surgeons (FWACS Urology). On completion of this study, provision will be made for review and publication in an international journal with high impact factor. Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol 12 months from the completion of study Patients with suspicion of prostate cancer presenting for core needle biopsy
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