Retrospective Study to Describe the Real-world Treatment Patterns and Associated Clinical Outcomes in Patients With Metastatic Castration-resistant Prostates Cancer (REMPRO)

September 4, 2023 updated by: AstraZeneca

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

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

1920

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Colombia
      • Valledupar, Colombia, 200005
        • Research Site
  • Egypt
      • Alexandria, Egypt, 21500
        • Research Site
      • Cairo, Egypt, 11796
        • Research Site
      • Cairo, Egypt, 11517
        • Research Site
      • Cairo, Egypt, 11522
        • Research Site
      • Cairo, Egypt, 11835
        • Research Site
      • Luxor, Egypt, 23701
        • Research Site
  • India
    • Delhi
      • New Delhi, Delhi, India, 110005
        • Research Site
      • New Delhi, Delhi, India, 110029
        • Research Site
      • New Delhi, Delhi, India, 110085
        • Research Site
    • Gujarat
      • Ahmedabad, Gujarat, India, 380015
        • Research Site
    • Haryana
      • Faridabad, Haryana, India, 121001
        • Research Site
    • Jammu And Kashmir
      • Srinagar, Jammu And Kashmir, India, 190011
        • Research Site
    • Karnataka
      • Bengaluru, Karnataka, India, 560027
        • Research Site
    • Maharashtra
      • Mumbai, Maharashtra, India, 400012
        • Research Site
    • Odisha
      • Bhubaneshwar, Odisha, India, 751007
        • Research Site
    • Telangana
      • Secundrabad, Telangana, India, 500003
        • Research Site
    • West Bengal
      • Howrah, West Bengal, India, 711103
        • Research Site
  • Korea, Republic of
    • Gyeonggi
      • Goyang-si, Gyeonggi, Korea, Republic of, 10408
        • Research Site
      • Seongnam-si, Gyeonggi, Korea, Republic of
        • Research Site
    • Seoul
      • Gangnam-gu, Seoul, Korea, Republic of
        • Research Site
      • Jongno-gu, Seoul, Korea, Republic of
        • Research Site
      • Seocho-gu, Seoul, Korea, Republic of
        • Research Site
      • Seodaemun-gu, Seoul, Korea, Republic of
        • Research Site
  • Peru
      • Lima, Peru, 15036
        • Research Site
  • Saudi Arabia
      • Riyadh, Saudi Arabia, 11525
        • Research Site
      • Riyadh, Saudi Arabia, 11564
        • Research Site
  • Turkey
      • Turkey, Turkey
        • Research Site
  • United Arab Emirates
      • Alain, United Arab Emirates
        • Research Site
      • Dubai, United Arab Emirates
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Metastatic Castration-resistant PROstate Cancer confirmed by pathology and/or imaging diagnosed

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Describe the real-world treatment patterns in patients with mCRPC
Time Frame: 12 Months
Proportion of patients receiving each treatment regimen for each LOT
12 Months
Describe the real-world treatment patterns in patients with mCRPC
Time Frame: 12 Months
Dose and DoT for each regimen for each LOT, reason(s) for stopping treatment regimen in each LOT and drug-free period D
12 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Demographic and clinico-pathological profile
Time Frame: 12 Months
Describe the demographic vs clinico-pathological characteristics of patients diagnosed with mCRPC
12 Months
Survival outcomes associated with different treatment regimens used for mCRPC
Time Frame: 12 Months
Determine overall survival from the index date of mCRPC diagnosis
12 Months
Assess the real-world effectiveness
Time Frame: 12 Months
Disease progression (abstracted from clinical notes based on radiography or PSA) (including real-world progression-free survival [rwPFS] and real-world response rate [rwRR]) of different treatment regimens used for mCRPC
12 Months
BRCA1/2 and HRRm status
Time Frame: 12 Months
To characterize RCA1/2 and HRRm status in patients with mCRPC,
12 Months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess the utilization of healthcare resources during the treatment of mCRPC;(Hospitalization)
Time Frame: 12 Months
Number of days of all hospitalizations and discharge with reasons for hospitalization.
12 Months
Assess the utilization of healthcare resources during the treatment of mCRPC;(Healthcare Facility)
Time Frame: 12 Months
Type of healthcare facility at hospitalization
12 Months
Assess the utilization of healthcare resources during the treatment of mCRPC;(Insurance)
Time Frame: 12 Months
Type of heath care insurance type
12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 28, 2021

Primary Completion (Actual)

September 30, 2022

Study Completion (Actual)

September 30, 2022

Study Registration Dates

First Submitted

March 9, 2021

First Submitted That Met QC Criteria

March 15, 2021

First Posted (Actual)

March 16, 2021

Study Record Updates

Last Update Posted (Actual)

September 7, 2023

Last Update Submitted That Met QC Criteria

September 4, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D0817R00037

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

IPD Sharing Time Frame

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing Access Criteria

When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Metastatic Castration-resistant Prostates Cancer

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Africa

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe