Scientific data review of prostate cancer patients to study treatment patterns and understand need gaps.
- Conditions
- Health Condition 1: N428- Other specified disorders of prostate
- Registration Number
- CTRI/2024/08/072504
- Lead Sponsor
- Pfizer Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. New diagnosis of mCRPC during the case selection window (between 15 April 2019 to 14 January 2022, inclusive). mCRPC is defined as the current and/or historical presence of metastases on any imaging modality with evidence of disease progression (a rising PSA or radiographic progression (as defined by the investigator) despite ongoing castration therapy [LHRH agonist / antagonist or prior surgical
orchiectomy]).
2. Aged at least 18 years upon diagnosis of mCRPC.
Of note, patients may be alive or deceased at the date of data abstraction.
Previously enrolled in an interventional trial related to CRPC (patients may have been
enrolled in trials of primary treatment and/or hormone-sensitive prostate cancer).
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Describe demographic and clinical characteristics at first diagnosis of mCRPC. <br/ ><br>Document treatment patterns from original prostate cancer diagnosis leading up to, <br/ ><br>upon and following diagnosis of mCRPC. <br/ ><br>Assess clinical outcomes among patients diagnosed with mCRPC, including <br/ ><br>prostate-specific antigen (PSA) response, real-world progression-free survival (PFS), <br/ ><br>real-world objective response rate (ORR), OS, and death by treatment lines. <br/ ><br>Report mCRPC-specific HCRU where applicable <br/ ><br>Document time on treatment for each line of treatment for mCRPC <br/ ><br>Document time to next treatment from initiation of a systemic therapy line to the <br/ ><br>commencement of the subsequent systemic therapy line for mCRPC <br/ ><br>Document time to subsequent chemotherapy from initiation of first-line systemic <br/ ><br>treatment for mCRPCTimepoint: 24 Months
- Secondary Outcome Measures
Name Time Method ATimepoint: NA