A Registry of Participants With Prostate Cancer in Asia
21 de septiembre de 2020 actualizado por: Janssen Research & Development, LLC
A Multicenter, Prospective, Longitudinal Registry of Patients With Prostate Cancer in Asia
The purpose of this study is to document prostate cancer (PC) management including diagnosis, prognosis, treatment, and care in real-world practice.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
De observación
Inscripción (Actual)
3644
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Seoul, Corea, república de
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Bangalore, India
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Delhi, India
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Mumbai, India
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New Delhi, India
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Chiba, Japón
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Hirosaki, Japón
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Ikoma, Japón
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Kobe, Japón
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Koshigaya, Japón
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Matsuyama, Japón
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Osaka-Sayama, Japón
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Suita, Japón
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Kuala Lumpur, Malasia
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Kuala Lumpur N/a, Malasia
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Kuching, Malasia
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Pulau Pinang, Malasia
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Beijing, Porcelana
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Guangzhou, Porcelana
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Hangzhou, Porcelana
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Shanghai, Porcelana
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Shenyang, Porcelana
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Sichuan, Porcelana
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Su Zhou, Porcelana
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Wuhan, Porcelana
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Singapore, Singapur
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Bangkok, Tailandia
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Chiang Mai, Tailandia
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Songkla, Tailandia
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Kaohsiung, Taiwán
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Tainan, Taiwán
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Taipei, Taiwán
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
21 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Masculino
Método de muestreo
Muestra no probabilística
Población de estudio
Participants with High-risk localized prostate cancer (PC), Non-metastatic, biochemically recurrent PC and Metastatic PC will be enrolled in this study.
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Grupo
- Perspectivas temporales: Futuro
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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High-risk localized Prostate Cancer (PC)
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).
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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.
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Non-metastatic Biochemically Recurrent PC
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).
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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.
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Metastatic PC
No intervention will be administered in this study.
Participants with Metastatic PC will be enrolled.
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Overall Survival (OS)
Periodo de tiempo: up to 5 years
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Overall survival is defined as the time from enrollment to date of death due to any cause.
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up to 5 years
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Prostate Cancer (PC)-related Mortality (PM)
Periodo de tiempo: up to 5 years
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PC-related mortality is the death due to prostate cancer.
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up to 5 years
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Metastasis-free survival (MFS)
Periodo de tiempo: up to 5 years
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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.
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up to 5 years
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Progression-free Survival (PFS)
Periodo de tiempo: up to 5 years
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Progression-free Survival is the time from enrollment to the occurrence of disease progression or death.
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up to 5 years
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Time to Prostate-specific Antigen (PSA) Progression (TTPP)
Periodo de tiempo: up to 5 years
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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.
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up to 5 years
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European Quality of Life-5 Dimensions, 5 Levels (EQ-5D-5L) Score
Periodo de tiempo: up to 5 years
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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.
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up to 5 years
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Functional Assessment of Cancer Therapy for Prostate Cancer (FACT-P) Score
Periodo de tiempo: up to 5 years
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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.
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up to 5 years
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Uemura H, Ye D, Kanesvaran R, Chiong E, Lojanapiwat B, Pu YS, Rawal SK, Abdul Razack AH, Zeng H, Chung BH, Md Yusoff NA, Ohyama C, Kim CS, Leewansangtong S, Tsai YS, Liu Y, Liu W, van Kooten Losio M, Asinas-Tan M. United in Fight against prOstate cancer (UFO) registry: first results from a large, multi-centre, prospective, longitudinal cohort study of advanced prostate cancer in Asia. BJU Int. 2020 Apr;125(4):541-552. doi: 10.1111/bju.14980. Epub 2020 Jan 30.
- Liu Y, Uemura H, Ye D, Lee JY, Chiong E, Pu YS, Razack AHA, Pripatnanont C, Rawal S, Low GKM, Qiu H, Chow WH, Van Kooten Losio M. Prostate cancer in Asia: design of a patient registry to inform real-world treatments, outcomes, and quality of life. Prostate Int. 2019 Sep;7(3):108-113. doi: 10.1016/j.prnil.2018.12.001. Epub 2018 Dec 24.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
9 de septiembre de 2015
Finalización primaria (Actual)
1 de septiembre de 2020
Finalización del estudio (Actual)
1 de septiembre de 2020
Fechas de registro del estudio
Enviado por primera vez
9 de septiembre de 2015
Primero enviado que cumplió con los criterios de control de calidad
9 de septiembre de 2015
Publicado por primera vez (Estimar)
11 de septiembre de 2015
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
22 de septiembre de 2020
Última actualización enviada que cumplió con los criterios de control de calidad
21 de septiembre de 2020
Última verificación
1 de septiembre de 2020
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CR107351
- NOPRODPCR4001 (Otro identificador: Janssen Research & Development, LLC)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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