Metastatic Castration-resistant Prostates Cancer Clinical Trial
— REMPROOfficial 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
| Verified date | August 2023 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 1920 |
| Est. completion date | September 30, 2022 |
| Est. primary completion date | September 30, 2022 |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | 18 Years and older |
| Eligibility | 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) |
| Country | Name | City | State |
|---|---|---|---|
| Colombia | Research Site | Valledupar | |
| Egypt | Research Site | Alexandria | |
| Egypt | Research Site | Cairo | |
| Egypt | Research Site | Cairo | |
| Egypt | Research Site | Cairo | |
| Egypt | Research Site | Cairo | |
| Egypt | Research Site | Luxor | |
| India | Research Site | Ahmedabad | Gujarat |
| India | Research Site | Bengaluru | Karnataka |
| India | Research Site | Bhubaneshwar | Odisha |
| India | Research Site | Faridabad | Haryana |
| India | Research Site | Howrah | West Bengal |
| India | Research Site | Mumbai | Maharashtra |
| India | Research Site | New Delhi | Delhi |
| India | Research Site | New Delhi | Delhi |
| India | Research Site | New Delhi | Delhi |
| India | Research Site | Secundrabad | Telangana |
| India | Research Site | Srinagar | Jammu And Kashmir |
| Korea, Republic of | Research Site | Gangnam-gu | Seoul |
| Korea, Republic of | Research Site | Goyang-si | Gyeonggi |
| 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 | Seongnam-si | Gyeonggi |
| Peru | Research Site | Lima | |
| Saudi Arabia | Research Site | Riyadh | |
| Saudi Arabia | Research Site | Riyadh | |
| Turkey | Research Site | Turkey | |
| United Arab Emirates | Research Site | Alain | |
| United Arab Emirates | Research Site | Dubai |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
Colombia, Egypt, India, Korea, Republic of, Peru, Saudi Arabia, Turkey, United Arab Emirates,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Assess the utilization of healthcare resources during the treatment of mCRPC;(Hospitalization) | Number of days of all hospitalizations and discharge with reasons for hospitalization. | 12 Months | |
| Other | Assess the utilization of healthcare resources during the treatment of mCRPC;(Healthcare Facility) | Type of healthcare facility at hospitalization | 12 Months | |
| Other | Assess the utilization of healthcare resources during the treatment of mCRPC;(Insurance) | Type of heath care insurance type | 12 Months | |
| Primary | Describe the real-world treatment patterns in patients with mCRPC | Proportion of patients receiving each treatment regimen for each LOT | 12 Months | |
| Primary | 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 | 12 Months | |
| Secondary | Demographic and clinico-pathological profile | Describe the demographic vs clinico-pathological characteristics of patients diagnosed with mCRPC | 12 Months | |
| Secondary | Survival outcomes associated with different treatment regimens used for mCRPC | Determine overall survival from the index date of mCRPC diagnosis | 12 Months | |
| Secondary | 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 | 12 Months | |
| Secondary | BRCA1/2 and HRRm status | To characterize RCA1/2 and HRRm status in patients with mCRPC, | 12 Months |