| CTRI Number |
CTRI/2024/03/064175 [Registered on: 15/03/2024] Trial Registered Prospectively |
| Last Modified On: |
14/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Diagnostic accuracy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Usefulness of combining Prostate Health Index with MRI of the prostate for the diagnosis of prostate cancer in patients with inconclusive PSA levels |
|
Scientific Title of Study
|
Clinical utility of combining Prostate Health Index with multiparametric MRI for diagnosis of prostate cancer with grey zone PSA levels |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Muhamed Tajudeen |
| Designation |
Senior Resident |
| Affiliation |
Christian Medical College |
| Address |
Department of Urology,
Christian Medical College
Vellore
TAMIL NADU
632517
India |
| Phone |
|
| Fax |
|
| Email |
tajudeen9495@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Santosh Kumar |
| Designation |
Professor |
| Affiliation |
Christian Medical College |
| Address |
Department of Urology,
Christian Medical College,
Vellore
Vellore
TAMIL NADU
632517
India |
| Phone |
8754230369 |
| Fax |
|
| Email |
ektasantosh@cmcvellore.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Santosh Kumar |
| Designation |
Professor |
| Affiliation |
Christian Medical College |
| Address |
Department of Urology,
Christian Medical College,
Vellore
TAMIL NADU
632517
India |
| Phone |
8754230369 |
| Fax |
|
| Email |
ektasantosh@cmcvellore.ac.in |
|
|
Source of Monetary or Material Support
|
| Christian Medical College |
|
|
Primary Sponsor
|
| Name |
Christian Medical College, Vellore |
| Address |
Ratnagiri,
Kilminnal,
Vellore |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Muhamed Tajudeen |
Christian Medical College, Vellore |
Department of Urology
Vellore
TAMIL NADU |
8946089690
tajudeen9495@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C61||Malignant neoplasm of prostate, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Male |
| Details |
Patients with PSA levels of 4-10 ng/ml, even those detected at surveillance |
|
| ExclusionCriteria |
| Details |
Patients who have cardiac pacemakers, Patients who have metallic implants in any part of the body, Extracapsular prostatic cancer on MpMRI Prostatitis, Prior TURP, Patients on 5α reductase inhibitors within the last three months, Patients who have coagulation disorders, Patients who had received prior hormonal therapy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To determine the performance of Prostate Health Index combined with MRI for
the diagnosis of prostate cancer and clinically significant prostate cancer in
patients with grey zone PSA levels |
At the time of diagnosis |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To determine the best threshold for PHI in Southeast Asian population in patients with PSA levels of 4-10 ng/ml
2. To determine the performance of other PSA variables like PSA density, free PSA, free/total PSA ratio, p2PSA, p2PSA/fPSA ratio, PHI density for the diagnosis of prostate cancer and clinically significant prostate cancer in
patients with PSA levels of 4-10 ng/ml
3, To assess the correlation of mpMRI in the diagnosis of prostate cancer and detection of clinically significant prostate cancer in PSA range of 4-10ng/ml. |
At diagnosis |
|
|
Target Sample Size
|
Total Sample Size="174"
Sample Size from India="174"
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)
|
23/03/2024 |
| 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="3"
Months="6"
Days="1" |
|
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
|
The study is to assess the sensitivity and specificity of combining a PSA-derived Prostate health index and multiparametric MRI of prostate inpatients whose PSA levels are inconclusive against the gold standard test of TRUS biopsy. In this way, we tend to ensure that these patients aren’t missed out. |