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CTRI Number  CTRI/2018/01/011570 [Registered on: 25/01/2018] Trial Registered Retrospectively
Last Modified On: 23/01/2018
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Other 
Public Title of Study   A Registry of Participants with Prostate Cancer in Asia 
Scientific Title of Study   A multicenter, prospective, longitudinal registry of patients with prostate cancer in Asia 
Trial Acronym  Not Applicable 
Secondary IDs if Any  
Secondary ID  Identifier 
NCT02546908  ClinicalTrials.gov 
NOPRODPCR4001  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name   
Designation   
Affiliation   
Address 




 
Phone    
Fax    
Email    
 
Details of Contact Person
Scientific Query
 
Name  Dr Vikram Singh MD Internal Medicine 
Designation  Vice President - Medical Affairs & Infectious Diseases 
Affiliation   
Address  Janssen (Pharmaceutical Companies of Johnson & Johnson) 501, Arena Space Behind Majas Bus Depot Off Jogeshwari Vikroli Link Road Jogeshwari East, Mumbai – 400060, India

Mumbai
MAHARASHTRA
400060
India 
Phone    
Fax    
Email  vsingh41@its.jnj.com  
 
Details of Contact Person
Public Query
 
Name  Dr Vikram Singh MD Internal Medicine 
Designation  Vice President - Medical Affairs & Infectious Diseases 
Affiliation   
Address  Janssen (Pharmaceutical Companies of Johnson & Johnson) 501, Arena Space Behind Majas Bus Depot Off Jogeshwari Vikroli Link Road Jogeshwari East, Mumbai – 400060, India

Mumbai
MAHARASHTRA
400060
India 
Phone    
Fax    
Email  vsingh41@its.jnj.com  
 
Source of Monetary or Material Support  
Janssen Asia Pacific, a division of Johnson and Johnson Pte Lmt, No 2, International Business Park, # 07-01, Tower one, Strategy, Singapore 609930  
 
Primary Sponsor  
Name  Janssen Research Development LLC 
Address  Janssen Asia Pacific, a division of Johnson and Johnson Pte Lmt No 2 International Business Park 07-01 Tower one Strategy Singapore 609930 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India
Japan
Malaysia
Republic of Korea
Singapore
Taiwan
Thailand  
Sites of Study  
No of Sites = 5  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Amlesh Seth  All India Institutes of Medical Sciences  Room # 5010B, 5th Floor, Teaching Block, Ansari Nagar , New Delhi, 110029, India
New Delhi
DELHI 
9868397433
0112658864
Amlesh.seth@gmail.com 
Dr Radheshyam Naik  Health Care Global Enterprises Ltd  Tower 1, 1st floor, Room#6, Medical Oncology Department, # 8, HCG Towers, P.Kalinga Rao Road, Sampangiram Nagar Bangalore - 560 027, Karnataka. India
Bangalore
KARNATAKA 
9731310682
08040206059
radheshyam_n@yahoo.com 
Dr Hemant Tongaonkar  P.D. Hinduja Hospital & Medical Research Centre  Department of Urological, Gynecological Surgical Oncology, Room # 1405, Veer Savarkar Marg, Mahim west Mumbai 400016, Maharashtra, India
Mumbai
MAHARASHTRA 
9820073911
02224448523
htongaonkar@gmail.com 
Dr Sudhir Rawal  Rajeev Gandhi Cancer Institute and Research Center  Department of Surgical Uro-Oncology, Sector- 5, Rohini, Delhi- 110085. India
South West
DELHI 
919810139757
01127051037
sudhirrawal85@gmail.com 
Dr Amit Joshi  Tata Memorial Hospital, Tata Memorial Centre  OPD Room # 225, Depaerment of Medical Oncology Dr. Ernest Borges Road Parel, Mumbai 400012, Maharashtra, India
Mumbai
MAHARASHTRA 
9769331525
02224146937
dramitjoshi74@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 5  
Name of Committee  Approval Status 
Clinical Research Ethics Committee-Dr. Hemant Tongaonkar  Submittted/Under Review 
Ethics Committee,-Dr. Amlesh Seth  Approved 
HCG – Central Ethics Committee-Dr. Radheshyam Naik  Approved 
IEC-Dr. Amit Joshi  Submittted/Under Review 
Institutional Review Board -Dr. Sudhir Rawal  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
No Objection Certificate 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Prostate cancer,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  99.00 Year(s)
Gender  Male 
Details  Male aged 21 years or older - Documented diagnosis of PC with either: High-risk localized PC; Nonmetastatic, biochemically recurrent PC;
Metastatic PC - Signed participation agreement/Informed Consent Form (ICF) by the patient or a legally acceptable
representative - Agree to be followed-up for PC per routine clinical care
 
 
ExclusionCriteria 
Details  No Specific Exclusion Criteria were defined  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.Overall Survival (OS)
2.Prostate Cancer (PC)-related Mortality (PM)
3.Metastasis-free survival (MFS)
4.Progression-free Survival (PFS)
5.Time to Prostate specific
Antigen (PSA) Progression (TTPP)
6.European Quality of Life-5 Dimensions,5 Levels (EQ-5D-5L) Score
7.Functional Assessment of Cancer Therapy for Prostate Cancer (FACT-P) Score
 
Up to 5 years
 
 
Secondary Outcome  
Outcome  TimePoints 
None  Not Applicable 
 
Target Sample Size   Total Sample Size="3690"
Sample Size from India="250" 
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)   06/05/2016 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  14/09/2015 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="5"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   None 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

The purpose of this study is to document prostate cancer (PC) management including diagnosis, prognosis, treatment, and care in real-world practice..


This is a multicenter (when more than one hospital or medical school team work on a medical research study), prospective (observation of a population for a sufficient number of persons over a sufficient number of years to generate incidence or mortality rates subsequent to the selection of the study group), longitudinal, observational registry (clinical study in which participants may receive diagnostic, therapeutic, or other types of interventions, but the investigator does not assign participants to specific interventions [as in an interventional study])of PC participants. The following 3 participant cohorts will be enrolled: high-risk localized PC, nonmetastatic biochemically recurrent PC, and metastatic PC. This is an observational study and treatment decisions and clinical management of participants will follow routine clinical practice. Medical care given to participants will not be influenced by participation in the study. Enrolled participants will be prospectively followed throughout their course of treatment, during which data on PC treatment, clinical progression, and outcomes (including death) will be collected. At the end of registry medical resource utilization (MRU) will also be collected. The maximum observational period will be 5 years. Safety will be monitored throughout the study for participants being treated with JNJ products

 
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