Robotic-arm Assisted 68 Ga PSMA PET/CT Guided Prostate Biopsy Versus MR Directed TRUS Guided Prostate Biopsy

Prostate Cancer Clinical Trial

— PROBIOP  

Official title:

Comparison of Robotic-arm Assisted 68 Ga PSMA PET/CT Guided Prostate Biopsy Versus MR Directed TRUS Guided (Cognitive Fusion) Prostate Biopsy: A Pilot Study to Assess Diagnostic Performance and Patient Safety

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05137561
• Other study ID #: NK/7840/MD/624
• Status: Recruiting
• Phase: N/A
• Start date: October 25, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: November 2021
• Source: Postgraduate Institute of Medical Education and Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The present study aimed to compare the diagnostic accuracy, radiation exposure, complication rates between 68Ga-PSMA PET/CT guided robotic arm assisted prostate biopsy and MRI directed TRUS guided prostate biopsy.

Description:

To compare the diagnostic yield of Robotic-arm assisted 68Ga PSMA PET/CT guided prostate biopsy and MRI directed TRUS guided prostate biopsy in patients with PIRADS grading 4/5.

To compare the visual pain index of the patients between two arms during the procedure.

To compare the complication rates between the two arms during and after the procedure for a period of 2 weeks

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2022
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 45 Years to 90 Years

Eligibility

Inclusion Criteria:

1. PIRADS 4 and 5 prostate lesions and PIRADS </= 3 prostate lesions with high clinical suspicion.

2. Patients who are included in the study will be randomly allocated into either PSMA PET/CT guided biopsy or TRUS guided biopsy using simple randomization in RRApp

Exclusion Criteria:

1. Patients with acute prostatitis/ urine culture positive.

2. Patients with pre-existing bleeding diathesis like hemophilia, coagulopathy defined by INR = 1.2, and Platelet counts = 80,000/mm3

3. Patients who refuse to provide the written informed consent

4. Non-cooperative patients

Related Conditions & MeSH terms

• Prostate Cancer
• Prostate Neoplasm
• Prostatic Neoplasms

Intervention

Procedure:
• PSMA PET guided prostate biopsy
PSMA PET-guided prostate biopsy from PSMA avid prostatic lesion will be done.
• MRI directed TRUS guided prostate biopsy
TRUS guided MR directed Cognitive fusion prostate biopsy based on the PIRADS scoring

Locations

Country	Name	City	State
India	PGIMER	Chandigarh	Chandigarh

Sponsors (1)

Lead Sponsor	Collaborator
Postgraduate Institute of Medical Education and Research

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic yield of mpMRI directed vs PET/CT directed prostate biopsy	The number of participants (with percentages) in whom the biopsy procedure yielded a tissue specimen adequate for a definite pathological diagnosis will be tabulated.	12 months
Primary	Diagnostic performance of mpMRI directed vs PET/CT directed prostate biopsy	The sensitivity, specificity and accuracy of mpMR directed TRUS guided (cognitive fusion) and PSMA PET/CT directed biopsy will be compared.	12 months
Secondary	Incidence of procedure related complications	The procedure-related complications in the number and percentage of recruiting participants will be tabulated.	three months