Prostate Cancer, Prostate Neoplasm
Conditions
Brief 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 in PIRADS 4/5 lesions.
Detailed 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
Interventions
PROCEDUREPSMA PET guided prostate biopsy
PSMA PET-guided prostate biopsy from PSMA avid prostatic lesion will be done.
PROCEDUREMRI directed TRUS guided prostate biopsy
TRUS guided MR directed Cognitive fusion prostate biopsy based on the PIRADS scoring
Sponsors
Post Graduate Institute of Medical Education and Research, Chandigarh
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Simple randomization using RRApp
Eligibility
Sex/Gender
MALE
Age
45 Years to 90 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic yield of mpMRI directed vs PET/CT directed prostate biopsy | 12 months | The number of participants (with percentages) in whom the biopsy procedure yielded a tissue specimen adequate for a definite pathological diagnosis and detection of PCa in both arms |
| Diagnostic performance of mpMRI directed vs PET/CT directed prostate biopsy | 12 months | The sensitivity, specificity and accuracy of mpMR directed TRUS guided (cognitive fusion) and PSMA PET/CT directed biopsy will be compared. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of procedure related complications | three months | The procedure-related complications in the number and percentage of recruiting participants will be tabulated. |
Countries
India
Outcome results
None listed