Study to Describe the Treatment Patterns and Associated Clinical Outcomes in Patients With Metastatic Castration-resistant PROstate Cancer
- Conditions
- Health Condition 1: C61- Malignant neoplasm of prostate
- Registration Number
- CTRI/2021/11/038126
- Lead Sponsor
- AstraZeneca Pharma India Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
1. 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 and at least 12 months of follow-up from the index date (unless the patient
died/lost to follow-up within the first 12 months after diagnosis)
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
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To describe the real-world treatment patterns in patients with mCRPCTimepoint: one time
- Secondary Outcome Measures
Name Time Method To describe the demographic and clinico-pathological characteristics of patients <br/ ><br>diagnosed with mCRPC <br/ ><br>To determine the survival outcomes associated with different treatment regimens used <br/ ><br>for mCRPC <br/ ><br>To assess the real-world effectiveness (including real-world progression-free survival <br/ ><br>[rwPFS] and real-world response rate [rwRR]) of different treatment regimens used for <br/ ><br>mCRPC <br/ ><br>To characterize BRCA1/2 and HRRm status in patients with mCRPC, if availableTimepoint: one time