An observational study in Metastatic Castration-resistant Prostates Cancer, sponsored by AstraZeneca. Completed at 30 sites in 8 countries. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-07.
Sponsored by AstraZeneca · 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.
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.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 1,920 is above the median of 200 across 1,181 observational studies indexed under Prostatic Neoplasms.
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Metastatic Castration-resistant PROstate Cancer confirmed by pathology and/or imaging diagnosed
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.
Describe the real-world treatment patterns in patients with mCRPC
Proportion of patients receiving each treatment regimen for each LOT
Time frame: 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
Time frame: 12 Months
Demographic and clinico-pathological profile
Describe the demographic vs clinico-pathological characteristics of patients diagnosed with mCRPC
Time frame: 12 Months
Survival outcomes associated with different treatment regimens used for mCRPC
Determine overall survival from the index date of mCRPC diagnosis
Time frame: 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
Time frame: 12 Months
BRCA1/2 and HRRm status
To characterize RCA1/2 and HRRm status in patients with mCRPC,
Time frame: 12 Months
Assess the utilization of healthcare resources during the treatment of mCRPC;(Hospitalization)
Number of days of all hospitalizations and discharge with reasons for hospitalization.
Time frame: 12 Months
Assess the utilization of healthcare resources during the treatment of mCRPC;(Healthcare Facility)
Type of healthcare facility at hospitalization
Time frame: 12 Months
Assess the utilization of healthcare resources during the treatment of mCRPC;(Insurance)
Type of heath care insurance type
Time frame: 12 Months
Plan to share: 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.
This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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