| CTRI Number |
CTRI/2026/01/101465 [Registered on: 19/01/2026] Trial Registered Prospectively |
| Last Modified On: |
16/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective |
| Study Design |
Other |
|
Public Title of Study
|
How blood tests (PSA), scans (MRI and PET-CT), trans rectal ultrasound-guided biopsy, and the removed prostate specimen after surgery for pathological examination, relate to each other in patients with prostate cancer. |
|
Scientific Title of Study
|
Correlation of PSA , MRI , TRUS Biopsy , PET- CT and RP Specimen findings in Carcinoma Prostate |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Version 4.0, dated 11/10/2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Patan Saif Khan |
| Designation |
DrNB Urology |
| Affiliation |
Narayana Health |
| Address |
Ground floor Dept of Urology Mazumdar Shaw Medical Centre NarayanaHealth City Bommasandra Industrial Area Hosur Road
Bangalore
KARNATAKA
560099
India |
| Phone |
9154114569 |
| Fax |
|
| Email |
pathansaifkhan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Saurabh Bhargava |
| Designation |
HOD & Senior Consultant |
| Affiliation |
Narayana Health |
| Address |
Ground floor Dept of Urology Mazumdar Shaw Medical Centre NarayanaHealth City Bommasandra Industrial Area Hosur Road
Bangalore
KARNATAKA
560099
India |
| Phone |
9154114569 |
| Fax |
|
| Email |
saurabh.bhargava.dr@narayanahealth.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Patan Saif Khan |
| Designation |
DrNB Urology |
| Affiliation |
Narayana Health |
| Address |
Ground floor Dept of Urology Mazumdar Shaw Medical Centre NarayanaHealth City Bommasandra Industrial Area Hosur Road
Bangalore
KARNATAKA
560099
India |
| Phone |
9154114569 |
| Fax |
|
| Email |
pathansaifkhan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Narayana Health, Bommasandra Industrial Area, Hosur Road, Bengaluru, Karnataka, 560099 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| 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 Patan Saif Khan |
Mazumdar Shaw Medical Centre |
Ground floor, Room no 31, Dept. of Urology, Mazumdar Shaw Medical Centre, Narayana Health City, Bommasandra Industrial Area, Hosur Road, Bengaluru
Bangalore
KARNATAKA |
9154114569
pathansaifkhan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Narayana health academic ethics committee |
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 |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients with histologically confirmed prostate adenocarcinoma.
Patients who have undergone Serum PSA testing within 1-3 months prior to imaging or biopsy, MRI with PI-RADS scoring, TRUS-guided biopsy,PET-CT and Radical Prostatectomy with histopathological examination of specimens.
Patients with localized or locally advanced disease (cT1–T3).
Patients with confirmed distant metastases (e.g., M1 stage).
Patients aged 50–80 years with ECOG Performance Status of 0–2.
Patients who have not undergone any prior treatment for prostate cancer (e.g., androgen deprivation therapy, chemotherapy, or radiation therapy).
Patients who provide written informed consent for participation and data usage in the study. |
|
| ExclusionCriteria |
| Details |
Patients who have received prior surgical, radiation, or pharmacological treatment for prostate cancer. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Is there a correlation between MRI findings / TRUS Biopsy of prostate + PSMA PET -CT findings in patient with abnormal PSA and finally co relate with Radical prostatectomy specimen? |
Until complete evaluation at baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the accuracy of each modality in predicting tumor volume, grade, & stage. |
Until complete evaluation at baseline |
| To analyze the concordance of imaging & biopsy with final RP pathology in multifocal vs. unifocal disease. |
Until complete evaluation at baseline |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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)
|
02/02/2026 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This study will include eligible patients attending the department of Urology, Narayana Health City, Bangalore for the evaluation and management of carcinoma prostate, who consent to be part of the study. Data on patient demographics, comorbidities, PSA levels, MRI PI-RADS scores, TRUS biopsy results, PET-CT findings, and radical prostatectomy (RP) specimen pathology results will be collected using a standardized proforma. The primary objective is to analyze is there a correlation between MRI Findings / TRUS Biopsy of prostate and PSMA PET -CT findings in patient with abnormal PSA and finally co relate with Radical prostatectomy specimen |