Pluvicto Real-world Investigation in Survival in Metastatic CRPC
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18+
SponsorNovartis Pharmaceuticals
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
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.
Patients with an mCRPC diagnosis on or after the metastatic diagnosis or satisfying any of the proxy criteria.
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.
Disqualifiers
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.
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).
Patients with missing age and gender information.
Trial population
Adult male patients with mCRPC in the US and Germany, who received \[177Lu\]Lu-PSMA-617.
Trial design
Design model
Other
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
1,085 Participants
are grouped into 3 trial groupsGroup A: Overall mCRPC Cohort
Group B: Chemo-naive mCRPC Cohort
Group C: Post-taxane mCRPC Cohort
Trial outcomes
Primary outcomes
1
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 years2
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 yearsSecondary outcomes
1
Baseline Demographics
Time frame
Baseline2
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
Baseline3
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
Baseline4
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
BaselineLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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