Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

A Study of Real-world Effectiveness of 177Lu-PSMA-617 With and Without Concurrent Androgen Receptor Pathway Inhibitors in Metastatic Castration Resistant Prostate Cancer Patients

4. november 2026 opdateret af: Novartis Pharmaceuticals

Real-world Effectiveness of 177Lu-PSMA-617 With and Without Concurrent Androgen Receptor Pathway Inhibitors in Patients With Metastatic Castration Resistant Prostate Cancer

This study aims to assess real-world clinical outcomes among adult metastatic castration-resistant prostate cancer (mCRPC) patients previously treated with and progressed on an androgen receptor pathway inhibitor (ARPI) who received 177Lu-PSMA-617 as a monotherapy or with concurrent ARPI. The study will use secondary data taken from a United States oncology database.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Undersøgelsestype

Observationel

Tilmelding (Anslået)

2045

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

  • Navn: Novartis Pharmaceuticals

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Han

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Adult male patients with mCRPC treated with 177Lu-PSMA-617 with or without concurrent ARPI on/after March 23, 2022 who received prior and progressed on an ARPI therapy in the metastatic setting.

Beskrivelse

Inclusion criteria:

  • Has an International Classification of Diseases (ICD) diagnosis of prostate cancer (ICD-9 185x; ICD-10 C61x)

  • At least two documented clinic visits on different days in the database network occurring on or after January 1, 2011.

  • Has evidence of prostate cancer with an initial or metastatic diagnosis date, as identified by a machine learning (ML) model from unstructured documents.

  • Diagnosis of mCRPC

  • Aged ≥18 years at mCRPC diagnosis.

  • Histology of Adenocarcinoma or prostate cancer, not otherwise specified (NOS).

  • Evidence of pre-index exposure to an ARPI (abiraterone acetate, enzalutamide, darolutamide, or apalutamide) in the metastatic setting

  • Evidence of ARPI progression on the ARPI line of treatment (LOT) immediately preceding 177Lu-PSMA-617 initiation, defined as

    • evidence of a progression date (per the database's real-world progression-free survival (rwPFS) variables), during or after the preceding ARPI LOT
    • a castration-resistant prostate cancer (CRPC) date occurring during or after the preceding ARPI LOT

  • Evidence of initiating a 177Lu-PSMA-617-containing LOT with or without a second-generation ARPI (abiraterone acetate, enzalutamide, darolutamide, or apalutamide) in mCRPC setting between 23 March 2022 and 31 October 2025, with concurrent therapies limited to androgen deprivation therapy (ADT) and/or 1st-generation antiandrogens only, and no other concurrent therapies permitted.

  • At least 6 months of potential minimum follow-up from the first 177Lu-PSMA-617-containing LOT

  • Patients may not receive a clinical study drug (CSD) any time prior to 177Lu-PSMA-617-containing LOT.

Exclusion criteria:

Applied to ARPI-experienced mCRPC patient cohort:

Individuals will be excluded if they meet any of the following criteria:

  • Evidence of unknown histology.
  • Patients enrolled in clinical trials at the time of 177Lu-PSMA-617 initiation.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: COHORT
  • Tidsperspektiver: RETROSPECTIVE

Kohorter og interventioner

Gruppe / kohorte
177Lu-PSMA-617 Monotherapy

mCRPC patients receiving 177Lu-PSMA-617 without concurrent ARPI. ADT and/or 1st-generation antiandrogens are allowed in the line. No other therapies are permitted during the line.
177Lu-PSMA-617 + ARPI Combination

mCRPC patients receiving 177Lu-PSMA-617 with concurrent ARPI. ADT and/or 1st-generation antiandrogens are allowed in the line. No other therapies are permitted in the line.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Real-world Overall Survival (rwOS)
Tidsramme: Up to approximately 4 years

rwOS defined as the time from the index date (177Lu-PSMA-617 treatment initiation) to date of death.
Up to approximately 4 years

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Baseline Demografi
Tidsramme: Baseline
Baseline
Real-world Time to Treatment Discontinuation (rwTTD)
Tidsramme: Up to approximately 4 years

rwTTD defined as the time from 177Lu-PSMA-617 index therapy start to 177Lu-PSMA-617 index therapy end (discontinuation, death, or ≥120-day gap).
Up to approximately 4 years
Real-world Progression-free Survival (rwPFS)
Tidsramme: Up to approximately 4 years

rwPFS defined as the time from the start date of 177Lu-PSMA-617 to the date of first progression occurring more than 14 days after the LOT start date, or date of death if no progression event is observed.
Up to approximately 4 years
Number of Patients by Clinical Characteristics
Tidsramme: Baseline

Clinical characteristics such as Eastern Cooperative Oncology Group (ECOG) performance status category (0-1, 2+), prostate specific antigen (PSA) level, Gleason score category (<8, ≥8), laboratory values, and prior ARPI LOTs.
Baseline

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Novartis Pharmaceuticals

Efterforskere

  • Studieleder: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

5. november 2026

Primær færdiggørelse (Anslået)

25. november 2026

Studieafslutning (Anslået)

25. november 2026

Datoer for studieregistrering

Først indsendt

4. november 2026

Først indsendt, der opfyldte QC-kriterier

4. november 2026

Først opslået (Faktiske)

10. november 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. november 2026

Sidst verificeret

1. november 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CJSB462B12001

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner