About this trial
The aim of this study is to assess treatment patterns, characteristics, and clinical outcomes among adults with metastatic castration-resistant prostate cancer (mCRPC) who have previously received ≥1 androgen receptor pathway inhibitor (ARPI), ≥1 taxane, and 177Lu-PSMA-617 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 volunteersQualifiers
Evidence of 177Lu-PSMA-617 use on or after 01 January 2021.
Evidence of treatment with ≥1 ARPI, before 177Lu-PSMA-617.
Evidence of treatment with ≥1 taxane, before or after 177Lu-PSMA-617.
Diagnosis of mCRPC prior to or on the index date. The index date is the date of the last treatment administration of the latest of an ARPI, taxane, and 177Lu-PSMA-617.
Disqualifiers
None
Trial population
Adult male patients with a diagnosis of mCRPC and evidence of prior treatment with ≥1 ARPI, ≥1 taxane, and 177Lu-PSMA-617 in the PRECISION data platform.
Trial design
Cohort
Retrospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Number of Patients by Number of Lines of Therapy (LOTs) Between mCRPC Diagnosis and Index Date
The index date is the date of the last treatment administration of the latest of an ARPI, taxane, and 177Lu-PSMA-617.
Number of Patients by Number and Type of Prior Therapies Indicated for Advanced Prostate Cancer (PC)
Number of patients by number and type of prior ARPI, taxane, 177Lu-PSMA-617, and other therapies indicated for advanced PC.
Number of Patients by Number of Prostate-specific Membrane Antigen (PSMA) Scans
Number of Patients by Timing of PSMA Scans
Timing of scans is categorized as pre-mCRPC diagnosis, post-mCRPC diagnosis but pre-index date, and post-index date. The index date is the date of the last treatment administration of the latest of an ARPI, taxane, and 177Lu-PSMA-617.
Secondary outcomes
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.
Age
Progression-free Survival (PFS) From Index Date
Time from the applicable index date until progression or death from any cause. The index date is the date of the last treatment administration of the latest of an ARPI, taxane, and 177Lu-PSMA-617.
PFS From Initiation of First Post-index Therapy, in Patients With ≥1 Post-index Therapy
Time from the initiation of first post-index therapy until progression or death from any cause.
Sponsors and contacts
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