| CTRI Number |
CTRI/2020/04/024855 [Registered on: 25/04/2020] Trial Registered Retrospectively |
| Last Modified On: |
25/04/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare standard 12 core TRUS prostate biopsy and MRI Fusion biospy to detect prostate cancer |
|
Scientific Title of Study
|
COMPARISON OF STANDARD 12 CORES SYSTEMATIC TRUS GUIDED BIOPSY AND MRI-FUSION BIOPSY IN THE DETECTION OF PROSTATE CANCER ¬– A PROSPECTIVE RANDOMIZED STUDY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Amlesh Seth |
| Designation |
PROFESSOR |
| Affiliation |
AIIMS |
| Address |
Department of Urology
AIIMS
New Delhi
AIIMS NEW DELHI
South
DELHI
110029
India |
| Phone |
9868397433 |
| Fax |
|
| Email |
amlesh.seth@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amlesh Seth |
| Designation |
PROFESSOR |
| Affiliation |
AIIMS |
| Address |
Department of Urology
AIIMS
New Delhi
AIIMS NEW DELHI
South
DELHI
110029
India |
| Phone |
9868397433 |
| Fax |
|
| Email |
amlesh.seth@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SRIDHAR P |
| Designation |
SENIOR RESIDENT |
| Affiliation |
AIIMS HOSPITAL |
| Address |
Department of Urology
AIIMS
New Delhi
AIIMS NEW DELHI
South
DELHI
110029
India |
| Phone |
9540101806 |
| Fax |
|
| Email |
sridharsoul@gmail.com |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT OF HEALTH RESEARCH
|
|
|
Primary Sponsor
|
| Name |
HRD SCHEME OF DHR for Young scientist |
| Address |
Department of Health Research
2nd Floor, IRCS Building,
1, Red Cross Road, New Delhi - 110001. |
| Type of Sponsor |
Government funding agency |
|
|
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 AMLESH SETH |
AIIMS |
Room no: 5030, Deaprtment of Urology, Teaching Block, AIIMS, Ansari Nagar,110029
South
DELHI |
9868397433
amlesh.seth@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS INSTITUTE ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N429||Disorder of prostate, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
12 CORE TRUS BIOPSY |
STANDARD TECHNIQUE IN THE DETECTION OF PROSTATE BIOPSY |
| Intervention |
MRI-TRUS FUSION BIOPSY |
NEWER TECHNIQUE IN THE DETECTION OF PROSTATE CANCER |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Male |
| Details |
1.Patients with elevated S.PSA level of 4-11 ng/ml
2.Suspected stage ≤ T2 on digital rectal examination
3.Signed informed consent
|
|
| ExclusionCriteria |
| Details |
1.Patients in whom MRI is contraindicated or not feasible
2.Previous history of prostate biopsy, prostate surgery or treatment of prostate cancer
3.Patients with active urinary tract infection
4.Patients with diffuse hard nodular prostate
5.Patients refusing participation in the study
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the additional contribution by MRI-TRUS fusion targeted biopsy versus the standard 12 cores systematic TRUS guided biopsy in prostate cancer detection |
18 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Patients in whom MRI is contraindicated or not feasible
2. Previous history of prostate biopsy, prostate surgery or treatment of prostate cancer
3.Patients with active urinary tract infection
4.Patients with diffuse hard nodular prostate
5.Patients refusing participation in the study
|
18 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="180"
Sample Size from India="180"
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)
|
03/12/2018 |
| 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="10"
Days="8" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Transrectal ultrasound-guided prostate biopsy (TRUS-Bx) has been the
cornerstone of prostate cancer (PCa) diagnosis. As an extension of mpMRI, a
novel and potentially transformative technique, MRI/TRUS fusion-guided biopsy,
has recently emerged as an option for a more precise prostate biopsy. Considering the technical complexity due to
implementation of robots, complex software, specific material and the longer
intervention time as well as the expensive cost, MRI/TRUS fusion biopsy cannot
be recommended for a routine application in all biopsy-naïve men with elevated
PSA. We intend to study the
additional role of mpMRI followed by MRI/TRUS fusion biopsy for PCa detection
as compared to the systematic 12 core TRUS guided biopsy in biopsy-naïve men
with elevated PSA and/or clinical suspicion of cancer by designing a
prospective randomized study. The null hypothesize for this study is that there
is no difference in terms of PCa detection between systematic 12 core TRUS
guided biopsy and mpMRI followed by MRI-TRUS fusion in biopsy-naïve men with
elevated PSA level of 4-11 ng/ml and/or clinical suspicion of cancer. |