Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04801186




Registration number
NCT04801186
Ethics application status
Date submitted
9/03/2021
Date registered
16/03/2021
Date last updated
7/09/2023

Titles & IDs
Public title
Retrospective Study to Describe the Real-world Treatment Patterns and Associated Clinical Outcomes in Patients With Metastatic Castration-resistant Prostates Cancer
Scientific 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
Secondary ID [1] 0 0
D0817R00037
Universal Trial Number (UTN)
Trial acronym
REMPRO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic Castration-resistant Prostates Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Describe the real-world treatment patterns in patients with mCRPC
Timepoint [1] 0 0
12 Months
Primary outcome [2] 0 0
Describe the real-world treatment patterns in patients with mCRPC
Timepoint [2] 0 0
12 Months
Secondary outcome [1] 0 0
Demographic and clinico-pathological profile
Timepoint [1] 0 0
12 Months
Secondary outcome [2] 0 0
Survival outcomes associated with different treatment regimens used for mCRPC
Timepoint [2] 0 0
12 Months
Secondary outcome [3] 0 0
Assess the real-world effectiveness
Timepoint [3] 0 0
12 Months
Secondary outcome [4] 0 0
BRCA1/2 and HRRm status
Timepoint [4] 0 0
12 Months

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key 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 design
Purpose
Duration
Selection
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/09/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/09/2022
Sample size
Target
Accrual to date
Final
1920
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Colombia
State/province [1] 0 0
Valledupar
Country [2] 0 0
Egypt
State/province [2] 0 0
Alexandria
Country [3] 0 0
Egypt
State/province [3] 0 0
Cairo
Country [4] 0 0
Egypt
State/province [4] 0 0
Luxor
Country [5] 0 0
India
State/province [5] 0 0
Delhi
Country [6] 0 0
India
State/province [6] 0 0
Gujarat
Country [7] 0 0
India
State/province [7] 0 0
Haryana
Country [8] 0 0
India
State/province [8] 0 0
Jammu And Kashmir
Country [9] 0 0
India
State/province [9] 0 0
Karnataka
Country [10] 0 0
India
State/province [10] 0 0
Maharashtra
Country [11] 0 0
India
State/province [11] 0 0
Odisha
Country [12] 0 0
India
State/province [12] 0 0
Telangana
Country [13] 0 0
India
State/province [13] 0 0
West Bengal
Country [14] 0 0
Korea, Republic of
State/province [14] 0 0
Gyeonggi
Country [15] 0 0
Korea, Republic of
State/province [15] 0 0
Seoul
Country [16] 0 0
Peru
State/province [16] 0 0
Lima
Country [17] 0 0
Saudi Arabia
State/province [17] 0 0
Riyadh
Country [18] 0 0
Turkey
State/province [18] 0 0
Turkey
Country [19] 0 0
United Arab Emirates
State/province [19] 0 0
Alain
Country [20] 0 0
United Arab Emirates
State/province [20] 0 0
Dubai

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04801186
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04801186