A Study of Real-World Characteristics, Treatment Patterns, and Clinical Outcomes in Patients With Metastatic Castration-Resistant Prostate Cancer

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18-115
SponsorNovartis Pharmaceuticals

About this trial

The aim of this study is to assess treatment patterns, clinical outcomes, and patient characteristics among adults with metastatic castration-resistant prostate cancer (mCRPC) in the United States (US) real-world clinical practice. This study will be conducted using data extracted from the PRECISION (PRostatE Cancer dISease observatION) data platform.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of mCRPC between 01 January 2021 and 31 December 2025.

Male sex at index, where index is the date of initial mCRPC diagnosis.

Age 18 years at index.

Disqualifiers

None

Trial population

Adult male patients with a confirmed mCRPC diagnosis in the US in the last 5 years who are included in the PRECISION data platform.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

17,111 Participants
are grouped into 1 trial group
Group A: mCRPC Cohort

Trial outcomes

Primary outcomes

1

Number of Patients by Prior Therapies

Time frame
Baseline
2

Number of Patients by Number of Post-index Lines of Therapy (LOTs)

Time frame
Up to approximately 5 years
3

Number of Patients by Type of Therapy at Each LOT

Time frame
Up to approximately 5 years
4

Percentage of Patients Switching From One Type of Therapy to Another at Each LOT

Time frame
Up to approximately 5 years

Secondary outcomes

1

Number of Patients by Patient Characteristics

Patient characteristics include race, geographical region, insurance status, marital status, type of treatment center, comorbidities, Gleason score, disease stage at diagnosis, and prostate-specific antigen (PSA) level.

Time frame
Baseline
2

Age

Time frame
Baseline
3

Progression-free Survival (PFS) From Index Date

PFS from index date: time from mCRPC diagnosis (index date) until progression or death from any cause.

Time frame
Up to approximately 5 years
4

PFS From Each LOT

PFS from each LOT, among those with that LOT: time from the date of initiation of the LOT until progression or death from any cause.

Time frame
Up to approximately 5 years

Other outcomes

Sponsors and contacts

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