Prostatic Neoplasms, Castration-Resistant
Conditions
Keywords
Metastatic Castration-Resistant Prostate Cancer, Androgen Pathway Modulation-Resistant, APMR
Brief summary
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.
Interventions
None listed
Sponsors
Novartis Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to 115 Years
Healthy volunteers
No
Inclusion criteria
* 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. * Age ≥18 years at index.
Exclusion criteria
• None.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients by Number of Lines of Therapy (LOTs) Between mCRPC Diagnosis and Index Date | Baseline | 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) | Baseline | 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 | Baseline up to approximately 5 years | — |
| Number of Patients by Timing of PSMA Scans | Baseline up to approximately 5 years | 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. |
| Number of Patients by Number of Post-index LOTs | Up to approximately 5 years | — |
| Number of Patients by Type of Therapy at Each Post-index LOT | Up to approximately 5 years | — |
| Time From Index Date to Next Therapy Initiation | Up to approximately 5 years | The index date is the date of the last treatment administration of the latest of an ARPI, taxane, and 177Lu-PSMA-617. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients by Patient Characteristics | Baseline | 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 | Baseline | — |
| Progression-free Survival (PFS) From Index Date | Up to approximately 5 years | 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 | Up to approximately 5 years | Time from the initiation of first post-index therapy until progression or death from any cause. |
| Overall Survival (OS) From Index Date | Up to approximately 5 years | Time from the applicable index date until 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. |
| OS From Initiation of First Post-index Therapy, in Those With ≥1 Post-index Therapy | Up to approximately 5 years | Time from initiation of first post-index therapy until death from any cause. |
| Among Patients With ≥1 Post-index Therapy, Number of Patients With a Reduction in PSA Level | Up to approximately 5 years | Reduction in PSA level categorized as follows: * ≥50% (PSA50) reduction in PSA level * ≥80% (PSA80) reduction in PSA level * ≥90% (PSA90) reduction in PSA level |
| Among Patients With ≥1 Post-index Therapy, Number of Patients With PSA <0.2 ng/mL on First Post-index Therapy | Up to approximately 5 years | — |
Countries
United States
Contacts
CONTACTNovartis Pharmaceuticals
STUDY_DIRECTORNovartis Pharmaceuticals
Novartis Pharmaceuticals
Outcome results
None listed