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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02546908 |
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Date of registration:
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09/09/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Registry of Participants With Prostate Cancer in Asia
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Scientific title:
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A Multicenter, Prospective, Longitudinal Registry of Patients With Prostate Cancer in Asia |
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Date of first enrolment:
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September 9, 2015 |
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Target sample size:
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3644 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02546908 |
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Study type:
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Observational [Patient Registry] |
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Study design:
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Phase:
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Countries of recruitment
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China
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India
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Japan
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Korea, Republic of
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Malaysia
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Singapore
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Taiwan
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Thailand
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Contacts
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Name:
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Janssen Research & Development, LLC Clinical Trial |
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Address:
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Telephone:
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Email:
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Affiliation:
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Janssen Research & Development, LLC |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Male aged 21 years or older
- Documented diagnosis of PC with either: High-risk localized PC; Non-metastatic,
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's were defined
Age minimum:
21 Years
Age maximum:
N/A
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Prostatic Neoplasms
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Intervention(s)
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Other: No Intervention
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Primary Outcome(s)
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Overall Survival (OS)
[Time Frame: up to 5 years]
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European Quality of Life-5 Dimensions, 5 Levels (EQ-5D-5L) Score
[Time Frame: up to 5 years]
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Prostate Cancer (PC)-related Mortality (PM)
[Time Frame: up to 5 years]
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Time to Prostate-specific Antigen (PSA) Progression (TTPP)
[Time Frame: up to 5 years]
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Functional Assessment of Cancer Therapy for Prostate Cancer (FACT-P) Score
[Time Frame: up to 5 years]
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Metastasis-free survival (MFS)
[Time Frame: up to 5 years]
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Progression-free Survival (PFS)
[Time Frame: up to 5 years]
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Secondary ID(s)
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NOPRODPCR4001
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CR107351
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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