Prostatic Neoplasms
Conditions
Keywords
Prostatic Neoplasms, Non-interventional, Observational
Brief summary
The purpose of this study is to document prostate cancer (PC) management including diagnosis, prognosis, treatment, and care in real-world practice.
Detailed 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.
Interventions
OTHERNo 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.
Sponsors
Janssen Research & Development, LLC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | up to 5 years | Overall survival is defined as the time from enrollment to date of death due to any cause. |
| Prostate Cancer (PC)-related Mortality (PM) | up to 5 years | PC-related mortality is the death due to prostate cancer. |
| Metastasis-free survival (MFS) | up to 5 years | 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. |
| Progression-free Survival (PFS) | up to 5 years | Progression-free Survival is the time from enrollment to the occurrence of disease progression or death. |
| Time to Prostate-specific Antigen (PSA) Progression (TTPP) | up to 5 years | 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. |
| European Quality of Life-5 Dimensions, 5 Levels (EQ-5D-5L) Score | up to 5 years | 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. |
| Functional Assessment of Cancer Therapy for Prostate Cancer (FACT-P) Score | up to 5 years | 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. |
Countries
China, India, Japan, Malaysia, Singapore, South Korea, Taiwan, Thailand
Outcome results
None listed