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Real-world results of Pluvicto in prostate cancer that has spread and resists hormone therapy

Looks at how Pluvicto works in everyday care for advanced prostate cancer.

Key facts

Who runs it
Novartis Pharmaceuticals
Where
East Hanover, United StatesSee the site
Trial code
Registry title
Pluvicto Real-world Investigation in Survival in Metastatic CRPC
Status
Recruiting
People taking part
1,085 people, planned
Started
1 Oct 2026
Expected to end
31 Jan 2027
Type of study
Observational, 3 groups
Record updated
30 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The study looks at men with prostate cancer that has spread and no longer responds to hormone-lowering treatment, who have received [177Lu]Lu-PSMA-617 (Pluvicto). It uses existing health records from the US and Germany.

Age
18 years or older on the date the cancer spread was diagnosed.
Sex
Men only.
Disease stage
Metastatic castration-resistant prostate cancer (mCRPC): prostate cancer that has spread and no longer responds to hormone-lowering treatment.
Earlier treatment
Must have received [177Lu]Lu-PSMA-617 after the mCRPC diagnosis. Must have at least 12 months of medical history before this treatment and at least six months after it (unless the patient died).

Main reasons for not taking part

  • Another non-prostate cancer in the three years before the first prostate cancer diagnosis
  • Taking part in another clinical trial around the time of the first [177Lu]Lu-PSMA-617 treatment or after it
  • Missing age or gender information in the records

The registry criteria, word for word

Show all 10 criteriaShow less

Who can take part

  • 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)

Who cannot take part

  • 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

Where in United States

  • NovartisEast Hanover, United StatesContact: Novartis PharmaceuticalsTaking people

About the trial

What the trial wants to find out

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.

The 3 groups in the trial

  • Overall mCRPC Cohort

    Adult male mCRPC patients who have received at least one dose of \[177Lu\]Lu-PSMA-617.

  • Chemo-naive mCRPC Cohort

    A sub-group of the Overall mCRPC Cohort. Adult male mCRPC patients who have received at least one dose of \[177Lu\]Lu-PSMA-617 and have not received chemotherapy in the mCRPC stage.

  • Post-taxane mCRPC Cohort

    A sub-group of the Overall mCRPC Cohort. Adult male mCRPC patients who have received at least one dose of \[177Lu\]Lu-PSMA-617 after taxane-based chemotherapy in the mCRPC stage.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Real World Clinical Effectiveness of [177Lu]Lu-PSMA-617 in Metastatic Castration Resistant Prostate Cancer (mCRPC) Patients: A Non-Interventional Study
Plain-language title
Real-world results of Pluvicto in prostate cancer that has spread and resists hormone therapyGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 13 November 2026.
Record updated
30 October 2026