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CTRI Number  CTRI/2025/02/080627 [Registered on: 14/02/2025] Trial Registered Prospectively
Last Modified On: 08/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A randomized study of comparing transperineal and transrectal prostate biopsy methods using ultrasound for detecting cancer in a suspected carcinoma prostate patients to compare various complications and histopathological outcome 
Scientific Title of Study   Comparison between ultrasound guided transperineal and transrectal prostate biopsy for suspected carcinoma prostate: a randomized controlled 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  Dr Jitendra Singh Rathor 
Designation  Senior Resident  
Affiliation  All India Institute of Medical Sciences, Jodhpur 
Address  OPD Room no 550, 5 th floor C block, Department of Urology, AIIMS Jodhpur, Basni Phase II Industrial area, Jodhpur

Jodhpur
RAJASTHAN
342005
India 
Phone  8765297080  
Fax    
Email  drjitendrasingh94@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Deepak Prakash Bhirud 
Designation  Assistant Professor  
Affiliation  All India Institute of Medical Sciences, Jodhpur 
Address  OPD Room no 550, 5 th floor C block, Department of Urology, AIIMS Jodhpur, Basni Phase II Industrial area, Jodhpur

Jodhpur
RAJASTHAN
342005
India 
Phone  7835056077  
Fax    
Email  deepakprakashbhirud05@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Jitendra Singh Rathor 
Designation  Senior Resident 
Affiliation  All India Institute of Medical Sciences, Jodhpur 
Address  OPD Room no 550, 5 th floor C block, Department of Urology, AIIMS Jodhpur, Basni Phase II Industrial area, Jodhpur

Jodhpur
RAJASTHAN
342005
India 
Phone  8765297080  
Fax    
Email  drjitendrasingh94@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences (AIIMS), Jodhpur, Basni (Phase-II), Industrial Area, Rajasthan, India-342005 
 
Primary Sponsor  
Name  Dr Jitendra Singh Rathor 
Address  OPD room no.550,5th floor, C block, Department of Urology, AIIMS Jodhpur, Rajasthan, 342005  
Type of Sponsor  Other [] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Jitendra Singh Rathor  All India Institute of Medical Sciences, Jodhpur  OPD Room No. 550, 5th Floor, C Block, Department of Urology, AIIMS Jodhpur, Basni Phase II,Industrial area
Jodhpur
RAJASTHAN 
8765297080

drjitendrasingh94@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional EthicsCommittee (Clinical trail), All India Institute of Medical Sciences, Jodhpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C61||Malignant neoplasm of prostate, (2) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  TRUS(transrectal ultrasound) guided Trans-rectal biopsy  In Left Lateral position TRUS guided Trans-rectal biopsy will be taken in predetermined pattern.  
Intervention  TRUS(transrectal ultrasound) guided Transperineal Biopsy  In Lithotomy position Ultrasound probe to be placed in the rectum, samples of the prostate are taken in a pre-determined pattern with guide provided by the grid.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Male 
Details  PSA more than 4 ng/ml for two times
Abnormal DRE Findings like hard or nodular prostate
MP-MRI findings or PIRADS more than equal to 3 
 
ExclusionCriteria 
Details  Patient Does not give consent
Patients unfit for biopsy
Previous history of Prostate biopsy 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare overall complications in TRUS guided transperineal and transrectal prostate biopsy.  On the 7th and 15th day after biopsy, each patient will be scheduled for a telephone review to assess possible complications. Long-term follow-up will be performed on an “as-needed” basis
 
 
Secondary Outcome  
Outcome  TimePoints 
(1) Adequacy of sample tissue retrieval in terms of presence of prostatic tissue, length of core & cancer detection rate

(2) To compare procedure time in TRUS guided transperineal & transrectal prostate biopsy

 
On the 15th day after biopsy, each patient will be scheduled to review Histopathology report.

Procedure time will be recorded after completion of procedure for each patient. Estimated procedure time is 25 to 30 minutes in transperineal biopsy method & 20 to 25 minutes in transrectal biopsy method.

After that overall data will be assesed after enrolling of all proposed patients, at the time of theses submission in June 2026. 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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   N/A 
Date of First Enrollment (India)   27/02/2025 
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)  Open to Recruitment 
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
Modification(s)  

TRUS guided transperineal biopsy (TPBx) and TRUS guided transrectal biopsy (TRBx) are the two primary approaches to obtain prostate tissue for diagnosis of PCa. Their main differences lie in the puncture site, puncture route and the TRUS transducer. In TPBx, the needle punctures through skin at the perineum under the guidance of a bi-planar transducer; while in TRBx, the needle punctures through the anterior rectal wall under the guidance of an end-fire transducer. Potential drawback of the transrectal approach includes the increased febrile postprocedural urinary tract infections (UTIs). In contrast, transperineal ultrasound-guided prostate biopsies (TPPBx) have been linked to increased postprocedural urinary retention rates, appear to be more invasive than TRPBx and cannot easily be delivered in an outpatient setting, as they often need general anesthesia or sedation. Thus with the introduction of local anesthesia such as pudendal nerve block and the adoption of freehand techniques have contributed to the feasibility of performing TP biopsy.

 
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