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
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.
연구 개요
상태
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Novartis Pharmaceuticals
- 전화번호: +41613241111
- 이메일: novartis.email@novartis.com
연구 연락처 백업
- 이름: Novartis Pharmaceuticals
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
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.
설명
Inclusion criteria:
-
Has an International Classification of Diseases (ICD) diagnosis of prostate cancer (ICD-9 185x; ICD-10 C61x)
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At least two documented clinic visits on different days in the database network occurring on or after January 1, 2011.
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Has evidence of prostate cancer with an initial or metastatic diagnosis date, as identified by a machine learning (ML) model from unstructured documents.
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Diagnosis of mCRPC
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Aged ≥18 years at mCRPC diagnosis.
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Histology of Adenocarcinoma or prostate cancer, not otherwise specified (NOS).
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Evidence of pre-index exposure to an ARPI (abiraterone acetate, enzalutamide, darolutamide, or apalutamide) in the metastatic setting
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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
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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.
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At least 6 months of potential minimum follow-up from the first 177Lu-PSMA-617-containing LOT
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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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: COHORT
- 시간 관점: RETROSPECTIVE
코호트 및 개입
그룹/코호트 |
|---|
|
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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Real-world Overall Survival (rwOS)
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
기준 인구 통계
기간: 기준선
|
기준선
|
|
|
Real-world Time to Treatment Discontinuation (rwTTD)
기간: 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)
기간: 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
기간: 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
|
공동 작업자 및 조사자
수사관
- 연구 책임자: Novartis Pharmaceuticals, Novartis Pharmaceuticals
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- CJSB462B12001
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
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