Metastatic Castration-resistant Prostates CancerREMPRONCT04801186
Retrospective Study to Describe the Real-world Treatment Patterns and Associated Clinical Outcomes in Patients With Metastatic Castration-resistant Prostates Cancer
An observational study of Metastatic Castration-resistant Prostates Cancer, run by AstraZeneca at 30 sites in 8 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Castration-resistant Prostates Cancer
- How many people
- 1,920 participants
- Where
- 30 sitesin 8 countries
- Study dates
- 28 Sep 2021to 30 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Metastatic Castration-resistant PROstate Cancer confirmed by pathology and/or imaging diagnosed
Who may be able to join
- 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)
Who cannot join
- -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)
Trial locations and contacts
30 sites in 8 countries.
30 sites in 8 countries
India11 sites
Research Site
Ahmedabad, Gujarat, 380015
Research Site
Bengaluru, Karnataka, 560027
Research Site
Bhubaneswar, Odisha, 751007
Research Site
Faridabad, Haryana, 121001
Research Site
Howrah, West Bengal, 711103
Research Site
Mumbai, Maharashtra, 400012
Research Site
New Delhi, National Capital Territory of Delhi, 110005
Research Site
New Delhi, National Capital Territory of Delhi, 110029
Research Site
New Delhi, National Capital Territory of Delhi, 110085
Research Site
Secundrabad, Telangana, 500003
Research Site
Srinagar, Jammu and Kashmir, 190011
Egypt6 sites
Research Site
Alexandria, 21500
Research Site
Cairo, 11517
Research Site
Cairo, 11522
Research Site
Cairo, 11796
Research Site
Cairo, 11835
Research Site
Luxor, 23701
South Korea6 sites
Research Site
Gangnam-gu, Seoul, 0
Research Site
Goyang-si, Gyeonggi-do, 10408
Research Site
Jongno-gu, Seoul, 0
Research Site
Seocho-gu, Seoul, 0
Research Site
Seodaemun-gu, Seoul, 0
Research Site
Seongnam-si, Gyeonggi-do, 0
Saudi Arabia2 sites
Research Site
Riyadh, 11525
Research Site
Riyadh, 11564
United Arab Emirates2 sites
Research Site
Alain, United Arab Emirates, 0
Research Site
Dubai, 0
About this study
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
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.
Read the 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Describe the real-world treatment patterns in patients with mCRPC
Proportion of patients receiving each treatment regimen for each LOT
Measured: 12 Months
Describe the real-world treatment patterns in patients with mCRPC
Dose and DoT for each regimen for each LOT, reason(s) for stopping treatment regimen in each LOT and drug-free period D
Measured: 12 Months
Secondary outcomes (4)
Demographic and clinico-pathological profile
Describe the demographic vs clinico-pathological characteristics of patients diagnosed with mCRPC
Measured: 12 Months
Survival outcomes associated with different treatment regimens used for mCRPC
Determine overall survival from the index date of mCRPC diagnosis
Measured: 12 Months
Assess the real-world effectiveness
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
Measured: 12 Months
BRCA1/2 and HRRm status
To characterize RCA1/2 and HRRm status in patients with mCRPC,
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2021
- Study start28 Sep 2021
- Primary completion30 Sep 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic Castration-resistant Prostates CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,920 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04801186
- Sponsor's protocol ID
- D0817R00037
- Acronym
- REMPRO
- Status last verified
- Aug 2023
- First submitted
- 9 Mar 2021
- Last updated
- 7 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- Individual data sharing
- Yes: 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.
Publications
Manneh R, Hashem T, Young JJ, Joshi A, Bahadir S, Omar A, Eid S, Elsayes A, Gonzalez F, Elsayed M, Kantharaju P. A REtrospective Study to Describe the Real-World Treatment Landscape in Patients with Metastatic Castration-Resistant PROstate Cancer: REMPRO. Adv Ther. 2026 Mar;43(3):1155-1171. doi: 10.1007/s12325-025-03472-5. Epub 2026 Jan 12.
PubMed 41525044
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04801186
- Acronym / sponsor ID
- REMPRO / D0817R00037
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,920 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 28 Sep 2021 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 16 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Metastatic Castration-resistant PROstate Cancer confirmed by pathology and/or imaging diagnosed
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (2 listed)
- -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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Describe the real-world treatment patterns in patients with mCRPC
Time frame: 12 Months
Proportion of patients receiving each treatment regimen for each LOT
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
4 secondary outcomes
Demographic and clinico-pathological profile
Time frame: 12 Months
Survival outcomes associated with different treatment regimens used for mCRPC
Time frame: 12 Months
Assess the real-world effectiveness
Time frame: 12 Months
BRCA1/2 and HRRm status
Time frame: 12 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
- Derived from this study: PubMed 41525044Manneh R, Hashem T, Young JJ, Joshi A, Bahadir S, Omar A, Eid S, Elsayes A, Gonzalez F, Elsayed M, Kantharaju P. A REtrospective Study to Describe the Real-World Treatment Landscape in Patients with Metastatic Castration-Resistant PROstate Cancer: REMPRO. Adv Ther. 2026 Mar;43(3):1155-1171. doi: 10.1007/s12325-025-03472-5. Epub 2026 Jan 12.
- Redacted CSR synopsisLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
30 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Castration-resistant Prostates Cancer, run by AstraZeneca at 30 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in India, Egypt, South Korea, Saudi Arabia, United Arab Emirates and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Describe the real-world treatment patterns in patients with mCRPC (time frame: 12 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04801186, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2023; AzTrials last refreshed its copy on 6 Nov 2026.