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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

Comparison between ultrasound guided transperineal and transrectal prostate biopsy for suspected carcinoma prostate: a randomized controlled trial - NIL

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/02/080627
Enrollment
200
Registered
2025-02-14
Start date
Unknown
Completion date
Unknown
Last updated
2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C61- Malignant neoplasm of prostate Health Condition 2: O- Medical and Surgical

Interventions

Intervention1: 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 patter

Sponsors

Dr Jitendra Singh Rathor
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: Patient Does not give consent Patients unfit for biopsy Previous history of Prostate biopsy

Design outcomes

Primary

MeasureTime frame
To compare overall complications in TRUS guided transperineal and transrectal prostate biopsy.Timepoint: 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

MeasureTime frame
(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 Timepoint: 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.

Countries

India

Contacts

Public ContactDr Jitendra Singh Rathor

All India Institute of Medical Sciences, Jodhpur

deepakprakashbhirud05@gmail.com7835056077

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026