|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
CTRI |
|
Last refreshed on:
|
24 November 2021 |
|
Main ID: |
CTRI/2018/01/011570 |
|
Date of registration:
|
25-01-2018 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
A Registry of Participants with Prostate Cancer in Asia
|
|
Scientific title:
|
A multicenter, prospective, longitudinal registry of patients with prostate cancer in Asia - Not Applicable |
|
Date of first enrolment:
|
06-05-2016 |
|
Target sample size:
|
3690 |
|
Recruitment status: |
Open to Recruitment |
|
URL:
|
http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=16302 |
|
Study type:
|
Observational |
|
Study design:
|
Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
India
|
Japan
|
Malaysia
|
Republic of Korea
|
Singapore
|
Taiwan
|
Thailand
| |
|
Contacts
|
|
Name:
|
Dr Vikram Singh MD Internal Medicine
|
|
Address:
|
Janssen (Pharmaceutical Companies of Johnson & Johnson)
501, Arena Space
Behind Majas Bus Depot
Off Jogeshwari Vikroli Link Road
Jogeshwari East, Mumbai â?? 400060, India
400060
Mumbai, MAHARASHTRA
India |
|
Telephone:
|
|
|
Email:
|
vsingh41@its.jnj.com |
|
Affiliation:
|
|
|
|
Name:
|
Dr Vikram Singh MD Internal Medicine
|
|
Address:
|
Janssen (Pharmaceutical Companies of Johnson & Johnson)
501, Arena Space
Behind Majas Bus Depot
Off Jogeshwari Vikroli Link Road
Jogeshwari East, Mumbai â?? 400060, India
400060
Mumbai, MAHARASHTRA
India |
|
Telephone:
|
|
|
Email:
|
vsingh41@its.jnj.com |
|
Affiliation:
|
|
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria: 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
Exclusion criteria: No Specific Exclusion Criteria were defined
Age minimum:
Age maximum:
Gender:
|
|
Health Condition(s) or Problem(s) studied
|
|
Health Condition 1: null- Prostate cancer
|
|
Intervention(s)
|
Intervention1: NIL: NIL
|
|
Primary Outcome(s)
|
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
Timepoint: Up to 5 years
|
|
Secondary Outcome(s)
|
|
NoneTimepoint: Not Applicable
|
|
Secondary ID(s)
|
|
NOPRODPCR4001
|
|
NCT02546908
|
|
Source(s) of Monetary Support
|
|
Janssen Asia Pacific,
a division of Johnson and Johnson Pte Lmt,
No 2, International Business Park, # 07-01,
Tower one, Strategy,
Singapore 609930
|
|
Ethics review
|
Status: Approved
Approval date: 21/09/2015
Contact:
Institutional Review Board -Dr. Sudhir Rawal
|
Status: Approved
Approval date: 28/09/2015
Contact:
HCG â?? Central Ethics Committee-Dr. Radheshyam Naik
|
Status: Approved
Approval date: 01/02/2016
Contact:
Ethics Committee,-Dr. Amlesh Seth
|
Status: Not Approved
Approval date:
Contact:
Clinical Research Ethics Committee-Dr. Hemant Tongaonkar
|
Status: Not Approved
Approval date:
Contact:
IEC-Dr. Amit Joshi
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|