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.
調査の概要
状態
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Novartis Pharmaceuticals
- 電話番号：+41613241111
- メール：novartis.email@novartis.com
研究連絡先のバックアップ
- 名前：Novartis Pharmaceuticals
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
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.
説明
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
-
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：COHORT
- 時間の展望：RETROSPECTIVE
コホートと介入
グループ/コホート |
|---|
|
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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Real-world Overall Survival (rwOS)
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
ベースライン人口統計
時間枠：ベースライン
|
ベースライン
|
|
|
Real-world Time to Treatment Discontinuation (rwTTD)
時間枠：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)
時間枠：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
時間枠：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
|
協力者と研究者
スポンサー
捜査官
- スタディディレクター：Novartis Pharmaceuticals、Novartis Pharmaceuticals
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- CJSB462B12001
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
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