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A Registry of Participants With Prostate Cancer in Asia

21 settembre 2020 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Osservativo

Iscrizione (Effettivo)

3644

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Cina
      • Beijing, Cina
      • Guangzhou, Cina
      • Hangzhou, Cina
      • Shanghai, Cina
      • Shenyang, Cina
      • Sichuan, Cina
      • Su Zhou, Cina
      • Wuhan, Cina
  • Corea, Repubblica di
      • Seoul, Corea, Repubblica di
  • Giappone
      • Chiba, Giappone
      • Hirosaki, Giappone
      • Ikoma, Giappone
      • Kobe, Giappone
      • Koshigaya, Giappone
      • Matsuyama, Giappone
      • Osaka-Sayama, Giappone
      • Suita, Giappone
  • India
      • Bangalore, India
      • Delhi, India
      • Mumbai, India
      • New Delhi, India
  • Malaysia
      • Kuala Lumpur, Malaysia
      • Kuala Lumpur N/a, Malaysia
      • Kuching, Malaysia
      • Pulau Pinang, Malaysia
  • Singapore
      • Singapore, Singapore
  • Tailandia
      • Bangkok, Tailandia
      • Chiang Mai, Tailandia
      • Songkla, Tailandia
  • Taiwan
      • Kaohsiung, Taiwan
      • Tainan, Taiwan
      • Taipei, Taiwan

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

21 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Maschio

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

Participants with High-risk localized prostate cancer (PC), Non-metastatic, biochemically recurrent PC and Metastatic PC will be enrolled in this study.

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Modelli osservazionali: Coorte
  • Prospettive temporali: Prospettiva

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
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).
Altro: 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.
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).
Altro: 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.
Metastatic PC
No intervention will be administered in this study. Participants with Metastatic PC will be enrolled.
Altro: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Overall Survival (OS)
Lasso di tempo: up to 5 years
Overall survival is defined as the time from enrollment to date of death due to any cause.
up to 5 years
Prostate Cancer (PC)-related Mortality (PM)
Lasso di tempo: up to 5 years
PC-related mortality is the death due to prostate cancer.
up to 5 years
Metastasis-free survival (MFS)
Lasso di tempo: 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.
up to 5 years
Progression-free Survival (PFS)
Lasso di tempo: up to 5 years
Progression-free Survival is the time from enrollment to the occurrence of disease progression or death.
up to 5 years
Time to Prostate-specific Antigen (PSA) Progression (TTPP)
Lasso di tempo: 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.
up to 5 years
European Quality of Life-5 Dimensions, 5 Levels (EQ-5D-5L) Score
Lasso di tempo: 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.
up to 5 years
Functional Assessment of Cancer Therapy for Prostate Cancer (FACT-P) Score
Lasso di tempo: 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.
up to 5 years

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Janssen Research & Development, LLC

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

9 settembre 2015

Completamento primario (Effettivo)

1 settembre 2020

Completamento dello studio (Effettivo)

1 settembre 2020

Date di iscrizione allo studio

Primo inviato

9 settembre 2015

Primo inviato che soddisfa i criteri di controllo qualità

9 settembre 2015

Primo Inserito (Stima)

11 settembre 2015

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

22 settembre 2020

Ultimo aggiornamento inviato che soddisfa i criteri QC

21 settembre 2020

Ultimo verificato

1 settembre 2020

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • CR107351
  • NOPRODPCR4001 (Altro identificatore: Janssen Research & Development, LLC)

Informazioni su farmaci e dispositivi, documenti di studio

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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