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CTRI Number  CTRI/2025/08/093511 [Registered on: 22/08/2025] Trial Registered Prospectively
Last Modified On: 22/08/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Knowledge And Perception about prostate cancer 
Scientific Title of Study   Knowledge And Perception regarding prostate cancer among middle aged men - A cross sectional Study 
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.Sayali Patil 
Designation  Assistant Professor 
Affiliation  KLE INSTITUTE OF PHYSIOTHERAPY 
Address  Advanced Physiotherapy Center Department of Oncology physiotherapy room no. 39, Sagar floor Belgaum KARNATAKA 590010 India
KLE INSTITUTE OF PHYSIOTHERAPY NEHRU NAGAR BELAGAVI KARNATAKA 590010 India
Belgaum
KARNATAKA
590010
India 
Phone  8793713489  
Fax    
Email  sayalipatil@klekipt.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Sayali Patil 
Designation  Assistant Professor 
Affiliation  KLE INSTITUTE OF PHYSIOTHERAPY 
Address  Advanced Physiotherapy Center, Department of Oncology physiotherapy room no. 39, Sagar floor Belgaum KARNATAKA 590010 India
KLE INSTITUTE OF PHYSIOTHERAPY NEHRU NAGAR BELAGAVI KARNATAKA 590010 India KARNATAKA 590010 India
Belgaum
KARNATAKA
590010
India 
Phone  8793713489  
Fax    
Email  sayalipatil@klekipt.edu.in  
 
Details of Contact Person
Public Query  
Name  Suyog Nerale 
Designation  intern  
Affiliation  KLE INSTITUTE OF PHYSIOTHERAPY 
Address  Advanced Physiotherapy Center Department of Oncology physiotherapy room no. 39, Sagar floor Belgaum KARNATAKA 590010 India
KLE INSTITUTE OF PHYSIOTHERAPY NEHRU NAGAR BELAGAVI KARNATAKA 590010 India Belgaum KARNATAKA 590010 India
Belgaum
KARNATAKA
590010
India 
Phone  08792046070  
Fax    
Email  suyognerale03@gmail.com  
 
Source of Monetary or Material Support  
Advanced Oncology Center, Department of pediatric physiotherapy, room no. 39, sagar floor, Belgaum KARNATAKA 590010 India 
 
Primary Sponsor  
Name  KLE INSTITUTE OF PHYSIOTHERAPY 
Address  Advanced Physiotherapy Center, Department of Oncology physiotherapy, room no. 39, sagar floor, Belgaum KARNATAKA 590010 India 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sayali Patil  KLE INSTITUTE OF PHYSIOTHERAPY  Advanced Physiotherapy Center, Department of Oncology physiotherapy, room no. 39, sagar floor, Belgaum KARNATAKA 590010 India
Belgaum
KARNATAKA 		 08793713489

sayalipatil@klekipt.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITTEE KAHER INSTITUTE OF PHYSIOTHERAPY  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  knowledge and perception regarding prostate cancer among middle aged men 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  middle aged men between 40-60 years.
participants willing to participate. 
 
ExclusionCriteria 
Details  patients already diagnosed with cancer.
participants who cannot comprehend questions. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
knowledge and perception regarding prostate cancer among middle-aged men  One time will be collected 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="218"
Sample Size from India="218" 
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)   03/09/2025 
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 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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [suyognerale03@gmail.com].

  6. For how long will this data be available start date provided 12-06-2025 and end date provided 12-08-2026?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
Compared to Western counterparts, Indian men are diagnosed with prostate cancer at a higher serum prostate-specific antigen (PSA) level and frequently exhibit more severe disease characteristics. This emphasizes how crucial early diagnosis and proactive management techniques are that are currently adapted to the Indian environment.
•Those over 39 have a higher risk of developing prostate cancer, which rises to 2.2% (1 in 45) for those between 40 and 59 and 13.7% (1 in 7) for those between 60 and 79. Prostate cancer will strike 16.7% of men in their lifetime, or 1 in 6. 
•Benign prostatic hyperplasia (BPH) is characterized by a set of symptoms that include urinary urgency, nocturia, hesitancy, intermittency, and increased frequency of urination. These symptoms are often progressive. Similar symptoms can be identified in the early stages of prostate cancer: hematuria, painful ejaculation, difficulty getting an erection, pain in the pelvis, and decreased frequency and flow of urine.
 
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