Pluvicto Real-world Investigation in Survival in Metastatic CRPC

N/ANot Yet RecruitingNCT07697989

Novartis Pharmaceuticals1,085 enrolled

Overview

This study aims to evaluate the various aspects of treatment effectiveness of \[177Lu\]Lu-PSMA-617 (Pluvicto) in mCRPC patients in both pre- and post-taxane settings. The study will be conducted using real-world data sources from the United States (US) and Germany.

Study Type

OBSERVATIONAL

Enrollment

1,085

Conditions

Prostatic Neoplasms, Castration-Resistant Neoplasm Metastasis

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion criteria: 1. Patients with at least one inpatient OR two outpatient primary prostate cancer (PC) diagnosis (International Classification of Diseases, Tenth Revision, Clinical Modification \[ICD-10-CM\]: C61) during the identification period. For outpatient diagnoses, the second confirmatory PC diagnosis must be at least 30 to 365 days after the first primary diagnosis date. 2. Patients with a metastatic diagnosis (ICD-10-CM: C77-C79) on or after the primary PC diagnosis date. The earliest metastatic diagnosis will be the patient's metastatic diagnosis date. 3. Patients with an mCRPC diagnosis on or after the metastatic diagnosis or satisfying any of the proxy criteria. 4. Patients with evidence of treatment with \[177Lu\]Lu-PSMA-617 after the mCRPC diagnosis date. The date of \[177Lu\]Lu-PSMA-617 administration will be considered as the index date. 5. Patients ≥18 years of age on metastatic diagnosis date. 6. Patients who are male. 7. Patients with at least 12 months pre-index and at least six months post-index (unless patient died) of medical history or continuous medical and pharmacy enrollment or activity (three-month allowable gap). Exclusion criteria: 1. Patients with other non-prostate primary cancer (≥ two ICD codes for one specific type of cancer in the baseline period at least 30 days apart) within three years prior to the first PC diagnosis. 2. Patients enrolled in a current clinical trial/investigational study within the 30-day period immediately prior to and including the index date or within five half-lives of the investigational product (whichever is longer) or during post-index period (ICD-10-CM: Z00.6). 3. Patients with missing age and gender information.

Outcomes

Primary Outcomes

Real-World Overall Survival (rwOS)

rwOS, defined as the time from index date, i.e., date of \[177Lu\]Lu-PSMA-617 administration, until death due to any cause.

Time frame: Up to approximately 3 years

Median rwOS

Median rwOS, defined as the time from the index date, i.e., date of \[177Lu\]Lu-PSMA-617 administration, to when half of the patients in the cohort are still alive.

Time frame: Up to approximately 3 years

Secondary Outcomes

Baseline Demographics

Time frame: Baseline

Proportion of Patients by Clinical Characteristic

Clinical characteristics (based on data availability): * Symptoms and signs of PC * Tumor characteristics * Prostate-specific membrane antigen (PSMA) positivity (PSMA positive, PSMA negative) * Previous therapies

Time frame: Baseline

Proportion of Patients by Clinical Characteristic: Eastern Cooperative Oncology Group (ECOG) Performance Status

ECOG performance status is a scale used to measure a patient's level of functioning in terms of self-care, daily activity, and physical ability. Scores range from 0 (fully active, able to carry out all pre-disease performance without restriction) to 5 (deceased).

Time frame: Baseline

Proportion of Patients by Clinical Characteristic: Karnofsky Performance Status

The Karnofsky performance status scale is an assessment scale used to measure an individual's functional status and ability to perform daily activities. The Karnofsky performance scale uses an 11-point scale in 10-point increments ranging from 100 (normal functioning) to 0 (deceased).

Time frame: Baseline

Central Contacts

Novartis Pharmaceuticals

CONTACT

+41613241111 novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

Data from ClinicalTrials.gov

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Duration Between Metastatic PC Diagnosis and mCRPC Diagnosis

Time frame: Baseline

Prostate Specific Antigen (PSA) Level

Time frame: Baseline

Testosterone Level

Time frame: Baseline

Lactate Dehydrogenase (LDH) Level

Time frame: Baseline

Alkaline Phosphatase (ALP) Level

Time frame: Baseline

Real-World Progression Free Survival (rwPFS)

rwPFS, defined as the time from the index date to the date of first documented progression, or next treatment initiation, or death from any cause, whichever occurs first.

Time frame: Up to approximately 3 years

Median rwPFS

Median rwPFS, defined as the time from the index date to when half of the patients in the cohort have disease progression or death.

Time frame: Up to approximately 3 years

Duration Between mCRPC Diagnosis and [177Lu]Lu-PSMA-617 Treatment Initiation

Time frame: Baseline

Number of Patients by Number of [177Lu]Lu-PSMA-617 Cycles Received

Time frame: Up to approximately 3 years

Time Interval Between Two Consecutive [177Lu]Lu-PSMA-617 Cycles

Time frame: Up to approximately 3 years

Proportion of Patients With a Dose Modification

Dose modification is defined as any change (reduction/escalation) in dose or frequency relative to the recommended dose in label.

Time frame: Up to approximately 3 years

Time-to-First Dose Modification

Dose modification is defined as any change (reduction/escalation) in dose or frequency relative to the recommended dose in label.

Time frame: Up to approximately 3 years

Proportion of Patients who Discontinue Treatment

Time frame: Up to approximately 3 years

Proportion of Patients who Switch Treatment

Proportion of patients who discontinue \[177Lu\]Lu-PSMA-617 treatment and initiate new drug(s).

Time frame: Up to approximately 3 years

Time-to-Treatment Discontinuation (TTD1L)

Time frame: Up to approximately 3 years

Time-to-Next Treatment (TTNT)

Time from initiation of \[177Lu\]Lu-PSMA-617 until the start date of the next treatment or death, whichever occurs first.

Time frame: Up to approximately 3 years

Proportion of Patients With Adverse Events

Time frame: Up to 42 days after the last dose of [177Lu]Lu-PSMA-617

Proportion of Patients With Safety Topics of Interest (STIs)

STIs: renal events, myelosuppression (cytopenias, bone marrow failure), dry mouth, second primary malignancies (other malignancies than the primary prostate cancer, including hematological and solid malignancies), dry eye.

Time frame: Up to approximately 3 years

Proportion of Prescriptions by Type of Specialty

Time frame: Baseline, up to approximately 3 years

Proportion of Prescriptions by Type of Practice Setting

Time frame: Baseline, up to approximately 3 years

Proportion of Patients by Type of Other Metastatic Prostate Cancer (mPC) Treatments Prior to [177Lu]Lu-PSMA-617 Treatment

Time frame: Baseline

Proportion of Patients by Type of Other mPC Treatments After [177Lu]Lu-PSMA-617 Treatment

Time frame: Up to approximately 3 years