A Registry of Participants With Prostate Cancer in Asia

Prostatic Neoplasms Clinical Trial

Official title:

A Multicenter, Prospective, Longitudinal Registry of Patients With Prostate Cancer in Asia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02546908
• Other study ID #: CR107351
• Secondary ID: NOPRODPCR4001
• Status: Completed
• Start date: September 9, 2015
• Est. completion date: September 1, 2020

Study information

• Verified date: September 2020
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3644
• Est. completion date: September 1, 2020
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostatic Neoplasms

Intervention

Other:
• No Intervention
This is an observational study. No study medication is provided will be provided as part of participation. Participants disease status, overall survival (OS), PFS, MFS, SRE-free survival, and time to castration (TTC) will be analyzed according to treatments prescribed while enrolled in the registry. All treatment decisions will be made at the discretion of the investigator or treating physician.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Countries where clinical trial is conducted

China,  India,  Japan,  Korea, Republic of,  Malaysia,  Singapore,  Taiwan,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival (OS)	Overall survival is defined as the time from enrollment to date of death due to any cause.	up to 5 years
Primary	Prostate Cancer (PC)-related Mortality (PM)	PC-related mortality is the death due to prostate cancer.	up to 5 years
Primary	Metastasis-free survival (MFS)	MFS is defined as the time from enrollment to the date of the first occurrence of radiographic bone or soft tissue distant metastasis, incidental pathologic finding of distant metastasis, or death from any cause, whichever occurs first.	up to 5 years
Primary	Progression-free Survival (PFS)	Progression-free Survival is the time from enrollment to the occurrence of disease progression or death.	up to 5 years
Primary	Time to Prostate-specific Antigen (PSA) Progression (TTPP)	TTPP is defined as time from enrollment to the date of PSA progression. In participants who has PSA level decreased, PSA progression is defined as 25 percent (%) increase (greater than or equal to [>=] 25%) from nadir (lowest value including baseline) and an increase in the absolute value of at least 2 nanogram per milliliter (ng/mL (>=2ng/mL) and is confirmed by a subsequent measurement at least 3 weeks (>=21 days; PCWG2) after the increase. In participants in whom the PSA level had not decreased, PSA progression is defined as 25% increase (>=25%) from baseline and an increase in the absolute value of at least 2ng/mL (>=2ng/mL) after 12 weeks.	up to 5 years
Primary	European Quality of Life-5 Dimensions, 5 Levels (EQ-5D-5L) Score	The EQ-5D-5L is the new 5-level version of EQ-5D. It describes health-related quality of life (HRQoL) states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Each item of the EQ-5D within these dimensions has 5 response options (no problems, slight problems, moderate problems, severe problems, or extreme problems). Data captured by EQ-5D-5L relates to the patient's status at the time of completion, and takes approximately 5 minutes to complete.	up to 5 years
Primary	Functional Assessment of Cancer Therapy for Prostate Cancer (FACT-P) Score	The FACT-P consists of the FACT-General (FACT-G) and a PC-specific subscale. The FACT-G contains a 27-item questionnaire and is composed of 4 dimensions of HRQoL: physical well-being, social/family well-being, emotional well-being, and functional well-being. The PC-specific subscale is composed of 12 items, which span the dimensions of sexual function, bowel/bladder function, and pain. The FACT-P questionnaire has a 7 day recall, and takes approximately 15 minutes to complete.	up to 5 years