| 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
|
|
|
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 |
|
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Regulatory Clearance Status from DCGI
|
|
|
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 |
|
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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. |