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Not yet recruiting NCT07697989

Pluvicto Real-world Investigation in Survival in Metastatic CRPC

— Observational Prostatic Neoplasms, Castration-Resistant Neoplasm Metastasis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Prostatic Neoplasms, Castration-Resistant, Neoplasm Metastasis. Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Real World Clinical Effectiveness of [177Lu]Lu-PSMA-617 in Metastatic Castration Resistant Prostate Cancer (mCRPC) Patients: A Non-Interventional Study

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.

Primary outcome measures

  • Real-World Overall Survival (rwOS) [Time frame: Up to approximately 3 years]
  • Median rwOS [Time frame: Up to approximately 3 years]
Secondary outcome measures (12)
  • Baseline Demographics [Time frame: Baseline]
  • Proportion of Patients by Clinical Characteristic [Time frame: Baseline]
  • Proportion of Patients by Clinical Characteristic: Eastern Cooperative Oncology Group (ECOG) Performance Status [Time frame: Baseline]
  • Proportion of Patients by Clinical Characteristic: Karnofsky Performance Status [Time frame: Baseline]
  • 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) [Time frame: Up to approximately 3 years]
  • Median rwPFS [Time frame: Up to approximately 3 years]
  • Duration Between mCRPC Diagnosis and [177Lu]Lu-PSMA-617 Treatment Initiation [Time frame: Baseline]

Eligibility criteria

Inclusion criteria

  • 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.
  • Patients ≥18 years of age on metastatic diagnosis date.
  • Patients who are male.
  • 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

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07697989 · CAAA617A12008

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗