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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

15 juli 2026 uppdaterad av: Novartis Pharmaceuticals

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

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.

Studieöversikt

Status

Rekrytering

Betingelser

Prostatiska neoplasmer, kastrationsresistenta

Studietyp

Observationell

Inskrivning (Beräknad)

1067

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Namn: Novartis Pharmaceuticals
Telefonnummer: +41613241111
E-post: novartis.email@novartis.com

Studera Kontakt Backup

Namn: Novartis Pharmaceuticals

Studieorter

Förenta staterna
- New Jersey
  - East Hanover, New Jersey, Förenta staterna, 07936
    - Rekrytering
    - Novartis

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

Vuxen
Äldre vuxen

Tar emot friska volontärer

Nej

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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.

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Antal grupper/kohorter

Kohorter och interventioner

Grupp / Kohort
Overall mCRPC Cohort Adult patients with a diagnosis of mCRPC and evidence of prior treatment with ≥1 ARPI, ≥1 taxane, and 177Lu-PSMA-617 in PRECISION.
mCRPC Progression Subgroup A subgroup of the Overall mCRPC Cohort. Patients with evidence of progression on or after 177Lu-PSMA-617 treatment.
≥1 Subsequent Systemic Therapy Subgroup A subgroup of the Overall mCRPC Cohort. Patients who initiate ≥1 post-index systemic therapy.

Vad mäter studien?

Primära resultatmått

Resultatmått	Åtgärdsbeskrivning	Tidsram
Number of Patients by Number of Lines of Therapy (LOTs) Between mCRPC Diagnosis and Index Date Tidsram: Baseline	The index date is the date of the last treatment administration of the latest of an ARPI, taxane, and 177Lu-PSMA-617.	Baseline
Number of Patients by Number and Type of Prior Therapies Indicated for Advanced Prostate Cancer (PC) Tidsram: Baseline	Number of patients by number and type of prior ARPI, taxane, 177Lu-PSMA-617, and other therapies indicated for advanced PC.	Baseline
Number of Patients by Number of Prostate-specific Membrane Antigen (PSMA) Scans Tidsram: Baseline up to approximately 5 years		Baseline up to approximately 5 years
Number of Patients by Timing of PSMA Scans Tidsram: 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.	Baseline up to approximately 5 years
Number of Patients by Number of Post-index LOTs Tidsram: Up to approximately 5 years		Up to approximately 5 years
Number of Patients by Type of Therapy at Each Post-index LOT Tidsram: Up to approximately 5 years		Up to approximately 5 years
Time From Index Date to Next Therapy Initiation Tidsram: 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.	Up to approximately 5 years

Sekundära resultatmått

Resultatmått	Åtgärdsbeskrivning	Tidsram
Ålder Tidsram: Baslinje		Baslinje
Number of Patients by Patient Characteristics Tidsram: 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.	Baseline
Progression-free Survival (PFS) From Index Date Tidsram: 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.	Up to approximately 5 years
PFS From Initiation of First Post-index Therapy, in Patients With ≥1 Post-index Therapy Tidsram: Up to approximately 5 years	Time from the initiation of first post-index therapy until progression or death from any cause.	Up to approximately 5 years
Overall Survival (OS) From Index Date Tidsram: 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.	Up to approximately 5 years
OS From Initiation of First Post-index Therapy, in Those With ≥1 Post-index Therapy Tidsram: Up to approximately 5 years	Time from initiation of first post-index therapy until death from any cause.	Up to approximately 5 years
Among Patients With ≥1 Post-index Therapy, Number of Patients With a Reduction in PSA Level Tidsram: 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	Up to approximately 5 years
Among Patients With ≥1 Post-index Therapy, Number of Patients With PSA <0.2 ng/mL on First Post-index Therapy Tidsram: Up to approximately 5 years		Up to approximately 5 years

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Novartis Pharmaceuticals

Utredare

Studierektor: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

30 juni 2026

Primärt slutförande (Beräknad)

30 november 2026

Avslutad studie (Beräknad)

30 november 2026

Studieregistreringsdatum

Först inskickad

24 juni 2026

Först inskickad som uppfyllde QC-kriterierna