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 |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
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Name |
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Designation |
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Affiliation |
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Address |
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Phone |
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Fax |
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Email |
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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 |
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Fax |
|
Email |
vsingh41@its.jnj.com |
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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 |
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Fax |
|
Email |
vsingh41@its.jnj.com |
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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
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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 |
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Details of Secondary Sponsor
|
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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 |
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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 |
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Regulatory Clearance Status from DCGI
|
Status |
No Objection Certificate |
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Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
Prostate cancer, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
NIL |
NIL |
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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
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ExclusionCriteria |
Details |
No Specific Exclusion Criteria were defined |
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Method of Generating Random Sequence
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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
|
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Secondary Outcome
|
Outcome |
TimePoints |
None |
Not Applicable |
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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)?
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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 |