A Registry of Participants with Prostate Cancer in Asia

Recruiting

Conditions: Prostate cancer

Registration Number: CTRI/2018/01/011570

Lead Sponsor: Janssen Research Development LLC

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

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Male

Target Recruitment: 3690

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.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Overall Survival (OS)	Up to 5 years
2.Prostate Cancer (PC)-related Mortality (PM)	Up to 5 years
3.Metastasis-free survival (MFS)	Up to 5 years
4.Progression-free Survival (PFS)	Up to 5 years
5.Time to Prostate specific	Up to 5 years
Antigen (PSA) Progression (TTPP)	Up to 5 years
6.European Quality of Life-5 Dimensions,5 Levels (EQ-5D-5L) Score	Up to 5 years
7.Functional Assessment of Cancer Therapy for Prostate Cancer (FACT-P) Score	Up to 5 years

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (5): All India Institutes of Medical Sciences
🇮🇳
Delhi, DELHI, India
Health Care Global Enterprises Ltd
🇮🇳
Bangalore, KARNATAKA, India
P.D. Hinduja Hospital & Medical Research Centre
🇮🇳
Mumbai, MAHARASHTRA, India
Rajeev Gandhi Cancer Institute and Research Center
🇮🇳
West, DELHI, India
Tata Memorial Hospital, Tata Memorial Centre
🇮🇳
Mumbai, MAHARASHTRA, India
All India Institutes of Medical Sciences
🇮🇳Delhi, DELHI, India
Dr Amlesh Seth
Principal investigator
9868397433
Amlesh.seth@gmail.com