A Registry of Participants With Prostate Cancer in Asia
21. september 2020 oppdatert av: 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.
Studieoversikt
Detaljert beskrivelse
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
Observasjonsmessig
Registrering (Faktiske)
3644
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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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, Japan
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Hirosaki, Japan
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Ikoma, Japan
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Kobe, Japan
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Koshigaya, Japan
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Matsuyama, Japan
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Osaka-Sayama, Japan
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Suita, Japan
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Beijing, Kina
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Guangzhou, Kina
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Hangzhou, Kina
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Shanghai, Kina
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Shenyang, Kina
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Sichuan, Kina
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Su Zhou, Kina
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Wuhan, Kina
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Seoul, Korea, Republikken
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Kuala Lumpur, Malaysia
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Kuala Lumpur N/a, Malaysia
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Kuching, Malaysia
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Pulau Pinang, Malaysia
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Singapore, Singapore
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Kaohsiung, Taiwan
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Tainan, Taiwan
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Taipei, Taiwan
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Bangkok, Thailand
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Chiang Mai, Thailand
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Songkla, Thailand
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
21 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Mann
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
Participants with High-risk localized prostate cancer (PC), Non-metastatic, biochemically recurrent PC and Metastatic PC will be enrolled in this study.
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Kohort
- Tidsperspektiver: Potensielle
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
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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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Overall Survival (OS)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
9. september 2015
Primær fullføring (Faktiske)
1. september 2020
Studiet fullført (Faktiske)
1. september 2020
Datoer for studieregistrering
Først innsendt
9. september 2015
Først innsendt som oppfylte QC-kriteriene
9. september 2015
Først lagt ut (Anslag)
11. september 2015
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
22. september 2020
Siste oppdatering sendt inn som oppfylte QC-kriteriene
21. september 2020
Sist bekreftet
1. september 2020
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CR107351
- NOPRODPCR4001 (Annen identifikator: Janssen Research & Development, LLC)
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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