A Registry of Participants With Prostate Cancer in Asia

Janssen (J&J Innovative Medicine)

Status: Completed

Conditions: Prostatic Neoplasms

Treatments: Other: No Intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT02546908

CR107351

NOPRODPCR4001 (Other Identifier)

Details and patient eligibility

About

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

Full description

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, non-metastatic 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.

Enrollment: 3,644 patients

Sex: Male

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

3,644 participants in 3 patient groups

High-risk localized Prostate Cancer (PC)

Description:

No intervention will be administered in this study. Participants with High-risk localized PC will be enrolled. High-risk localized PC involves clinical T stage greater than or equal to (\>=) cT3a and one of the following high risk features: Gleason score 8-10 or prostate specific antigen (PSA) level above 20 nanogram per milliliter (ng/mL).

Treatment:

Other: No Intervention

Non-metastatic Biochemically Recurrent PC

Description:

No intervention will be administered in this study. Participants with Non-metastatic biochemically recurrent PC will be enrolled. A non-metastatic biochemically recurrent PC involves a confirmed PSA value of \>0.2 ng/mL following prostatectomy (European Association of Urology (EAU) guidelines), a PSA value of 2 ng/mL or more above the nadir following radiation therapy (American Society for Radiation Oncology (ASTRO) guidelines).

Treatment:

Other: No Intervention

Metastatic PC

Description:

No intervention will be administered in this study. Participants with Metastatic PC will be enrolled.

Treatment:

Other: No Intervention