Clinical trial NCT04801186: Retrospective Study to Describe the Real-world Treatment Patterns and Associated Clinical Outcomes in Patients With Metastatic Castration-resistant Prostates Cancer
Official title: REMPRO Registry A Multi-country, Multi-centre, Non-interventional, Retrospective Study to Describe the Real-world Treatment Patterns and Associated Clinical Outcomes in Patients With Metastatic Castration-resistant Prostates Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Castration-resistant Prostates Cancer
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2021-03-16
Enrollment: 1920
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Metastatic Castration-resistant PROstate Cancer confirmed by pathology and/or imaging diagnosed

Brief summary: This is a multi-country, multi-centre, retrospective, non-interventional cohort study planned to include patients diagnosed with mCRPC between 01 January 2016 and 31 December 2018, who have received at least 1 line of treatment (LOT) in the mCRPC setting, and have 12 months of follow-up data available.

Detailed description: This is a multi-country, multi-centre, retrospective, non-interventional cohort study planned to include patients diagnosed with mCRPC between 01 January 2016 and 31 December 2018, who have received at least 1 line of treatment (LOT) in the mCRPC setting, and have 12 months of follow-up data available.To describe the real-world treatment patterns in patients with mCRPC

The data will be collected retrospectively between the date of diagnosis of mCRPC (index date) and the end of follow-up, i.e., until death, the last medical record entry, or the date of data extraction, whichever is the earliest. The data on different types of treatment received by the patients, sociodemographic and clinico-pathological characteristics, and healthcare utilization will be extracted from the medical records of patients (alive or deceased) into a centrally designed electronic data capture system. For the exploratory end point on real-world treatment patterns in patients with mCSPC, data on different types of treatment received by the patients, sociodemographic and clinico-pathological characteristics will be retrospectively extracted from the medical records of patients (alive or deceased) into a centrally designed electronic data capture system.

Eligibility criteria: Inclusion Criteria:

* Male patients ≥18 years of age OR legal age of being an adult in the country as per local regulations 2. Patient or next of kin/legal representative (for deceased patients at study entry, unless a waiver is granted) willing and able to provide written informed consent according to the local regulations 3. Patients with a diagnosis of metastatic (stage IV) mCRPC, confirmed by either biopsy of a metastatic tumour site or by history of biopsy-proven localized disease and evidence of metastatic disease on imaging studies (which is clearly noted in hospital/clinical records) and progression on ADT alone between 01 January 2016 and 31 December 2018 4. Availability of medical records at the participating site reflecting at least one LOT received in the mCRPC setting and 12 months of follow-up from the index date (unless the patient died or was lost to follow-up within the first 12 months after diagnosis)

Exclusion Criteria:

-1. Patients with a concomitant cancer at the time of diagnosis of mCRPC or those who are treated with any anti-cancer therapy indicated for other cancers within 6 months of diagnosis of mCRPC, except for non-metastatic non-melanoma skin cancers or in situ or benign neoplasms.

2. Patients unable to give an informed consent (unless a waiver is granted)

Primary outcomes:
measure: Describe the real-world treatment patterns in patients with mCRPC
timeFrame: 12 Months
measure: Describe the real-world treatment patterns in patients with mCRPC
timeFrame: 12 Months
Secondary outcomes:
measure: Demographic and clinico-pathological profile
timeFrame: 12 Months
measure: Survival outcomes associated with different treatment regimens used for mCRPC
timeFrame: 12 Months
measure: Assess the real-world effectiveness
timeFrame: 12 Months
measure: BRCA1/2 and HRRm status
timeFrame: 12 Months
Other outcomes:
measure: Assess the utilization of healthcare resources during the treatment of mCRPC;(Hospitalization)
timeFrame: 12 Months
measure: Assess the utilization of healthcare resources during the treatment of mCRPC;(Healthcare Facility)
timeFrame: 12 Months
measure: Assess the utilization of healthcare resources during the treatment of mCRPC;(Insurance)
timeFrame: 12 Months
Locations:
city: Valledupar
country: Colombia
facility: Research Site
city: Alexandria
country: Egypt
facility: Research Site
city: Cairo
country: Egypt
facility: Research Site
city: Cairo
country: Egypt
facility: Research Site
city: Cairo
country: Egypt
facility: Research Site
city: Cairo
country: Egypt
facility: Research Site
city: Luxor
country: Egypt
facility: Research Site
city: New Delhi
country: India
facility: Research Site
state: Delhi
city: New Delhi
country: India
facility: Research Site
state: Delhi
city: New Delhi
country: India
facility: Research Site
state: Delhi
city: Ahmedabad
country: India
facility: Research Site
state: Gujarat
city: Faridabad
country: India
facility: Research Site
state: Haryana
city: Srinagar
country: India
facility: Research Site
state: Jammu And Kashmir
city: Bengaluru
country: India
facility: Research Site
state: Karnataka
city: Mumbai
country: India
facility: Research Site
state: Maharashtra
city: Bhubaneshwar
country: India
facility: Research Site
state: Odisha
city: Secundrabad
country: India
facility: Research Site
state: Telangana
city: Howrah
country: India
facility: Research Site
state: West Bengal
city: Goyang-si
country: Korea, Republic of
facility: Research Site
state: Gyeonggi
city: Seongnam-si
country: Korea, Republic of
facility: Research Site
state: Gyeonggi
city: Gangnam-gu
country: Korea, Republic of
facility: Research Site
state: Seoul
city: Jongno-gu
country: Korea, Republic of
facility: Research Site
state: Seoul
city: Seocho-gu
country: Korea, Republic of
facility: Research Site
state: Seoul
city: Seodaemun-gu
country: Korea, Republic of
facility: Research Site
state: Seoul
city: Lima
country: Peru
facility: Research Site
city: Riyadh
country: Saudi Arabia
facility: Research Site
city: Riyadh
country: Saudi Arabia
facility: Research Site
city: Turkey
country: Turkey
facility: Research Site
city: Alain
country: United Arab Emirates
facility: Research Site
city: Dubai
country: United Arab Emirates
facility: Research Site
Study officials:
References: