A Study of Real-World Characteristics, Treatment Patterns, and Outcomes Among mCRPC Patients Previously Treated With an Androgen Receptor Pathway Inhibitor, Taxane-Based Chemotherapy, and Lutetium-177 Vipivotide Tetraxetan

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, 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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

1,067 Participants
are grouped into 3 trial groups
Group A: Overall mCRPC Cohort
Group B: mCRPC Progression Subgroup
Group C: ≥1 Subsequent Systemic Therapy Subgroup

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline
2

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.

Time frame
Baseline
3

Number of Patients by Number of Prostate-specific Membrane Antigen (PSMA) Scans

Time frame
Baseline up to approximately 5 years
4

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.

Time frame
Baseline 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

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.

Time frame
Up to approximately 5 years
4

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.

Time frame
Up to approximately 5 years

Other outcomes

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