- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02546908
A Registry of Participants With Prostate Cancer in Asia
21 septembre 2020 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Observationnel
Inscription (Réel)
3644
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Beijing, Chine
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Guangzhou, Chine
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Hangzhou, Chine
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Shanghai, Chine
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Shenyang, Chine
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Sichuan, Chine
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Su Zhou, Chine
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Wuhan, Chine
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Seoul, Corée, République de
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Bangalore, Inde
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Delhi, Inde
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Mumbai, Inde
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New Delhi, Inde
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Chiba, Japon
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Hirosaki, Japon
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Ikoma, Japon
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Kobe, Japon
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Koshigaya, Japon
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Matsuyama, Japon
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Osaka-Sayama, Japon
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Suita, Japon
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Kuala Lumpur, Malaisie
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Kuala Lumpur N/a, Malaisie
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Kuching, Malaisie
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Pulau Pinang, Malaisie
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Singapore, Singapour
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Kaohsiung, Taïwan
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Tainan, Taïwan
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Taipei, Taïwan
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Bangkok, Thaïlande
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Chiang Mai, Thaïlande
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Songkla, Thaïlande
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
21 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Homme
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
Participants with High-risk localized prostate cancer (PC), Non-metastatic, biochemically recurrent PC and Metastatic PC will be enrolled in this study.
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: Cohorte
- Perspectives temporelles: Éventuel
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
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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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Overall Survival (OS)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
9 septembre 2015
Achèvement primaire (Réel)
1 septembre 2020
Achèvement de l'étude (Réel)
1 septembre 2020
Dates d'inscription aux études
Première soumission
9 septembre 2015
Première soumission répondant aux critères de contrôle qualité
9 septembre 2015
Première publication (Estimation)
11 septembre 2015
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
22 septembre 2020
Dernière mise à jour soumise répondant aux critères de contrôle qualité
21 septembre 2020
Dernière vérification
1 septembre 2020
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- CR107351
- NOPRODPCR4001 (Autre identifiant: Janssen Research & Development, LLC)
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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