Real-World Treatment Patterns and Clinical Outcomes Among Patients with Metastatic Adenocarcinoma of the Prostate
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Pfizer Products India Private Limited
- Enrollment
- 300
- Locations
- 8
- Primary Endpoint
- Describe demographic and clinical characteristics at first diagnosis of metastatic
Overview
Brief Summary
Real-World Treatment Patterns and Clinical Outcomes Among Patients with Metastatic Adenocarcinoma of the Prostate.
This is a multicentric, non-interventional, real-world observational study involving the review of pertinent data from medical records.
The study cohort will consist of all patients who meet the eligibility criteria. The date of metastatic prostate cancer diagnosis will define the study index date (T1), which must occur during the case selection window of 01 January 2023 onwards. The selection of these study dates is based on consideration of the anticipated data collection date, the need to document current treatment patterns (from the first-line metastatic setting), and allowance of at least 18-month follow-up opportunity for the assessment of study outcomes, particularly OS.
The time of metastatic prostate cancer diagnosis (T1) will represent the baseline. The baseline characteristics and treatment history prior to T1 will be assessed. The follow-up period will begin on the index date (T1). Patients will be followed until date of death or the date of last recorded medical visit. Patients who died before 18 months of follow-up and patients who have less than 18 months of follow-up as of their last recorded medical visit will be allowed into the study. All patient medical records that occur during follow-up will be reviewed and data on treatment regimens, treatment characteristics, clinical outcomes, and
resource use will be extracted. Consistent with the routine-care of mCSPC and mCRPC patients and differences in healthcare systems across the country (India), the follow-up visits are likely to be different.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18.00 Year(s) to 99.00 Year(s) (—)
- Sex
- Male
Inclusion Criteria
- •Patients diagnosed and/or treated with mCSPC or mCRPC 01 January 2023 onwards, inclusive.
- •mCSPC is defined as the current and/or historical presence of metastases on any imaging modality sensitive to hormone therapy.
- •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 [ADT or prior surgical orchiectomy]).1,9 Aged at least 18 years upon diagnosis of mCSPC or mCRPC.
Exclusion Criteria
- •Previously enrolled in an interventional trial related to metastatic prostate cancer.
Outcomes
Primary Outcomes
Describe demographic and clinical characteristics at first diagnosis of metastatic
Time Frame: 18 months
adenocarcinoma of prostate (mCSPC and mCRPC).
Time Frame: 18 months
Document treatment patterns from original prostate cancer diagnosis in both mCSPC
Time Frame: 18 months
and mCRPC.
Time Frame: 18 months
Assess clinical outcomes among patients diagnosed with mCSPC and mCRPC,
Time Frame: 18 months
including PSA response and real-world progression-free survival (PFS) in DDR
Time Frame: 18 months
mutation/wild type, ORR, and OS.
Time Frame: 18 months
Report mCRPC-specific HCRU.
Time Frame: 18 months
Document time on treatment for each line of treatment for mCSPC and mCRPC.
Time Frame: 18 months
Document time to next treatment from initiation of a systemic therapy line to the
Time Frame: 18 months
commencement of the subsequent systemic therapy line for mCSPC and mCRPC.
Time Frame: 18 months
Document time to subsequent chemotherapy from initiation of first-line systemic
Time Frame: 18 months
treatment for mCSPC and mCSPC.
Time Frame: 18 months
Secondary Outcomes
- NA(NA)
Investigators
Dr Antara Chaudhri
Pfizer Products India Private Limited