| CTRI Number |
CTRI/2024/10/075192 [Registered on: 14/10/2024] Trial Registered Prospectively |
| Last Modified On: |
10/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
Type of Study
Modification(s)
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
Public Title of Study
Modification(s)
|
Comparing the performance of bp/mp-MRI of prostate, PSMA PET scan and Prostate biopsy in diagnosing Prostate Cancer |
Scientific Title of Study
Modification(s)
|
Comparative analysis of diagnostic performance of P.I.R.A.D.S of bp/mp-MRI of prostate and
Intraprostatic SUVmax of PSMA-PET, compared with ISUP Grading of Prostate Biopsy for diagnosing Prostate Cancer in a University Teaching Hospital in Karnataka.
|
| 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 Puppala Vinayaka Vishnu Vardhan |
| Designation |
Senior resident |
| Affiliation |
Department of Urology and Renal Transplant, Kasturba Medical College, Manipal |
| Address |
Department of Urology and Renal Transplant, first floor, srimathi sharada madhav pai OPD building, Kasturba Hospital Manipal, Udupi , Karnataka 576104
Udupi
KARNATAKA
576104
India |
| Phone |
8500322323 |
| Fax |
|
| Email |
drvinayakapuppala@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Padmaraj Hegde |
| Designation |
Pofessor |
| Affiliation |
Kasturba Hospital, Manipal |
| Address |
Department of Urology and Renal Transplant, first floor, srimathi sharada madhav pai OPD building, Kasturba Hospital Manipal, Udupi , Karnataka 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9900264579 |
| Fax |
|
| Email |
Padmaraj.hegde@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Puppala Vinayaka Vishnu Vardhan |
| Designation |
Senior resident |
| Affiliation |
Department of Urology and Renal Transplant, Kasturba Medical College, Manipal |
| Address |
Department of Urology and Renal Transplant, first floor, srimathi sharada madhav pai OPD building, Kasturba Hospital Manipal, Udupi , Karnataka 576104
Udupi
KARNATAKA
576104
India |
| Phone |
8500322323 |
| Fax |
|
| Email |
drvinayakapuppala@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Urology and Renal Transplant, first floor, srimathi sharada madhav pai OPD building, Kasturba Hospital Manipal, Udupi , Karnataka 576104 |
|
|
Primary Sponsor
|
| Name |
Dr Puppala Vinayaka Vishnu Vardhan |
| Address |
Department of Urology and Renal transplant, first floor, srimathi sharada madhav pai OPD building, Kasturba hospital, Manipal, Udupi, karanataka, 576104 |
| Type of Sponsor |
Other [Self] |
|
|
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 Puppala Vinayaka Vishnu Vardhan |
Kasturba Hospital |
Department of Urology and Renal Transplant, first floor, srimathi sharada madhav pai OPD building, Kasturba Hospital Manipal, Udupi , Karnataka 576104
Udupi
KARNATAKA |
8500322323
drvinayakapuppala@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N428||Other specified disorders of prostate, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
Inclusion Criteria
Modification(s)
|
| Age From |
45.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Male |
| Details |
Patients with suspicion of prostate cancer on digital rectal examination
Elevated serum PSA level > 3 ng/dl. |
|
| ExclusionCriteria |
| Details |
Patients who have undergone Prostate biopsy, bp/mp-MRI and PSMA-PET elsewhere
Coagulopathy
Painful anorectal conditions
Significant immunosuppression
Acute prostatitis
Contraindications for MRI
Contraindications for PET scan
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| The Data will be analysed to determine if bp/mp-MRI and PSMA PET can predict avoiding a biopsy in patient with clinically significant prostate cancer |
2 years |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
1)Accuracy of ISUP Grading of prostatic biopsy alone in detetcting prostate cancer
2)Accuracy of PIRADS of bp/mp-MRI alone in detecting prostate cancer
3)Accuracy of intraprostatic SUVmax value of PSMA PET alone in detecting prostate cancer
4)Accuracy of PIRADS of bp/mp-MRI of prostate with intraprostatic SUVmax of PSMA PET in detecting prostate cancer. |
2 years |
|
|
Target Sample Size
|
Total Sample Size="128"
Sample Size from India="128"
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)
|
25/10/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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)
|
The study will be conducted for a period of two years in Kasturba Hospital, Manipal by the Department of Urology and Renal Transplant, in the following manner.
1)Patients examined in urology OPD suspected of prostate cancer on Digital rectal examination and patients who have been diagnosed or suspected of prostate cancer from other departments are enrolled in study.2)An informed consent is obtained from patients who fit the inclusion criteria 3)Patients will undergo the following tests as a part of existing protocol in department - a)PSA b) PIRADS of bp/mp MRI of prostate c)PSMA PET Scan for PIRADS score >3 d)Prostate biopsy 4)Following values are obtained and analysed for consensus - a) PSA b) PIRADS c) Intraprostatic SUVmax d) ISUP grading 5)Statistical Analyses will be performed by obtaining the following values for ISUP grading PIRADS and intraprostatic SUVmax in diagnosing prostate cancer - a) sensitivity, specificity b)Negative predictive value, positive predictive vale c)Likelihood ratio d)Accuracy of test e) Area under ROC 6) The target sample is 128, however due to time restrictions, sample size achieved maybe time bound 7) In additional to the above data, retrospectively records of patients diagnosed with prostate cancer from the year 2020 will be examined. Patients who have undergone bp/mp-MRI of prostate and PSMA PET CT will be included in the study.
By comparing the diagnostic performance in detecting prostate cancer of the invasive test of prostate biopsy with the non invasive tests of bp/mp-MRI and PSMA PET scan, a more patient friendly pathway can be achieved towards diagnosing and treating prostate cancer. |