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A Registry of Participants With Prostate Cancer in Asia

21 september 2020 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Werkelijk)

3644

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • China
      • Beijing, China
      • Guangzhou, China
      • Hangzhou, China
      • Shanghai, China
      • Shenyang, China
      • Sichuan, China
      • Su Zhou, China
      • Wuhan, China
  • Indië
      • Bangalore, Indië
      • Delhi, Indië
      • Mumbai, Indië
      • New Delhi, Indië
  • Japan
      • Chiba, Japan
      • Hirosaki, Japan
      • Ikoma, Japan
      • Kobe, Japan
      • Koshigaya, Japan
      • Matsuyama, Japan
      • Osaka-Sayama, Japan
      • Suita, Japan
  • Korea, republiek van
      • Seoul, Korea, republiek van
  • Maleisië
      • Kuala Lumpur, Maleisië
      • Kuala Lumpur N/a, Maleisië
      • Kuching, Maleisië
      • Pulau Pinang, Maleisië
  • Singapore
      • Singapore, Singapore
  • Taiwan
      • Kaohsiung, Taiwan
      • Tainan, Taiwan
      • Taipei, Taiwan
  • Thailand
      • Bangkok, Thailand
      • Chiang Mai, Thailand
      • Songkla, Thailand

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

21 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Mannelijk

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Observatiemodellen: Cohort
  • Tijdsperspectieven: Prospectief

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
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).
Ander: 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).
Ander: 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.
Ander: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Overall Survival (OS)
Tijdsspanne: 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)
Tijdsspanne: up to 5 years
PC-related mortality is the death due to prostate cancer.
up to 5 years
Metastasis-free survival (MFS)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Janssen Research & Development, LLC

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

9 september 2015

Primaire voltooiing (Werkelijk)

1 september 2020

Studie voltooiing (Werkelijk)

1 september 2020

Studieregistratiedata

Eerst ingediend

9 september 2015

Eerst ingediend dat voldeed aan de QC-criteria

9 september 2015

Eerst geplaatst (Schatting)

11 september 2015

Updates van studierecords

Laatste update geplaatst (Werkelijk)

22 september 2020

Laatste update ingediend die voldeed aan QC-criteria

21 september 2020

Laatst geverifieerd

1 september 2020

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • CR107351
  • NOPRODPCR4001 (Andere identificatie: Janssen Research & Development, LLC)

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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