| CTRI Number |
CTRI/2025/05/087863 [Registered on: 28/05/2025] Trial Registered Prospectively |
| Last Modified On: |
13/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Diagnostic
Screening
Process of Care Changes |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
prostate biopsy for suspected prostate cancer |
|
Scientific Title of Study
|
Comparision of Transrectal vs Transperineal biopsy in suspected carcinoma prostate - an open label non inferior randomised control trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rahul Bhatia |
| Designation |
Senior Resident Academic Urology |
| Affiliation |
AIIMS Raipur |
| Address |
Bunglow number 6 , Ram Kuti , Fortune Residency , Tatibandh , Raipur
Department of Urology , AIIMS Raipur , Tatibandh , Raipur
Raipur
CHHATTISGARH
492099
India |
| Phone |
9717208737 |
| Fax |
|
| Email |
rahul.aiims13@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Amit Sharma |
| Designation |
Head of Department , Additional Professor |
| Affiliation |
AIIMS Raipur |
| Address |
Department of Urology , Ground Floor , C block , AIIMS Raipur , Tatibandh
Raipur
CHHATTISGARH
492099
India |
| Phone |
8691898668 |
| Fax |
|
| Email |
dramitsharma@aiimsraipur.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Rahul Bhatia |
| Designation |
Senior Resident Academic Urology |
| Affiliation |
AIIMS Raipur |
| Address |
Bunglow number 6 , Ram Kuti , Fortune Residency , Tatibandh ,Raipur
Department of Urology , AIIMS Raipur , Tatibandh , Raipur
Raipur
CHHATTISGARH
492099
India |
| Phone |
9717208737 |
| Fax |
|
| Email |
rahul.aiims13@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Urology , AIIMS Raipur , Tatibandh , Raipur , Chattishgarh , India
Pin code : 492099 |
|
|
Primary Sponsor
|
| Name |
Department of Urology |
| Address |
AIIMS Raipur , Tatibandh , Raipur , Chattisgarh , India
Pin Code : 492099 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Rahul Bhatia |
AIIMS Raipur |
Department of Urology , Ground Floor , Room number 4 , C block , AIIMS Raipur ( C.G.) 492099 , India
Raipur
CHHATTISGARH |
9717208737
rahul.aiims13@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee AIIMS Raipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N428||Other specified disorders of prostate, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Transperineal Prostate Biopsy |
Prostate biopsy will be taken through perineum route in one group of patients. Post transperineal biopsy results and complications will be assessed |
| Comparator Agent |
Transrectal Prostate Biopsy |
Prostate biopsy will be taken through rectal route in other group of patients. Post transrectal biopsy results and complications will be assessed |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Male |
| Details |
Adult males (40- 80 Years) who have indication of prostrate biopsy for detection of suspected prostrate CA with elevated PSA levels, abnormal DRE findings and/or abnormal TRUS/mpMRI findings
|
|
| ExclusionCriteria |
| Details |
Previous history of CA prostrate, acute prostatitis or proven urinary tract infection
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
• PRIMARY OBJECTIVE
To compare the infectious complication rate between transperineal and transrectal biopsy
|
30 DAYS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• SECONDARY OBJECTIVE
To compare the non-infectious complication rates and detection rate between transperineal and transrectal biopsy for CA prostrate.
|
30 DAYS |
|
|
Target Sample Size
|
Total Sample Size="260"
Sample Size from India="260"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/06/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Aim :Comparision of transrectal and transperineal biopsy in detection rate, infectious complication rate and non infectious complication rate for suspected carcinoma prostate. Research question : Can use of transperineal route for prostate biopsy reduce post biopsy complication rate as compared with transrectal biopsy. Hypothesis : Transrectal route of prostate biopsy has less complication rate with similar detection rate as compared with transrectal biopsy for suspected carcinoma prostate. Primary objective : To compare the infectious complication rate between transperineal and transrectal biopsy Secondary objective : To compare the non infectious complication rates and detection rate between transperineal and transrectal biopsy for ca prostate |