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Real world study of Advanced Prostate Cancer patients in India

Real-World Treatment Patterns and Clinical Outcomes Among Patients with Metastatic Adenocarcinoma of the Prostate - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2024/06/068779
Enrollment
300
Registered
2024-06-12
Start date
Unknown
Completion date
Unknown
Last updated
2024-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N428- Other specified disorders of prostate

Interventions

Intervention1: NIL: NIL Control Intervention1: NIL: NIL

Sponsors

Pfizer Products India Private Limited
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria: Previously enrolled in an interventional trial related to metastatic prostate cancer.

Design outcomes

Primary

MeasureTime frame
Describe demographic and clinical characteristics at first diagnosis of metastatic adenocarcinoma of prostate (mCSPC and mCRPC). Document treatment patterns from original prostate cancer diagnosis in both mCSPC and mCRPC. Assess clinical outcomes among patients diagnosed with mCSPC and mCRPC, including PSA response and real-world progression-free survival (PFS) in DDR mutation/wild type, ORR, and OS. Report mCRPC-specific HCRU. Document time on treatment for each line of treatment for mCSPC and mCRPC. Document time to next treatment from initiation of a systemic therapy line to the commencement of the subsequent systemic therapy line for mCSPC and mCRPC. Document time to subsequent chemotherapy from initiation of first-line systemic treatment for mCSPC and mCSPC.Timepoint: 18 months

Secondary

MeasureTime frame
NATimepoint: NA

Countries

India

Contacts

Public ContactDr Antara Chaudhri

Pfizer Products India Private Limited

antara.Chaudhri@pfizer.com2266932000

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026