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NCT Number: NCT07697989

Pluvicto Real-world Investigation in Survival in Metastatic CRPC

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.

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Key information

Conditions

Prostatic Neoplasms, Castration-Resistant Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Real-World Overall Survival (rwOS)

    Time frame: Up to approximately 3 years

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

  2. Median rwOS

    Time frame: Up to approximately 3 years

    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.

Secondary outcomes

  1. Baseline Demographics

    Time frame: Baseline

  2. Proportion of Patients by Clinical Characteristic

    Time frame: Baseline

    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

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

    Time frame: Baseline

    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).

  4. Proportion of Patients by Clinical Characteristic: Karnofsky Performance Status

    Time frame: Baseline

    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).

  5. Duration Between Metastatic PC Diagnosis and mCRPC Diagnosis

    Time frame: Baseline

  6. Prostate Specific Antigen (PSA) Level

    Time frame: Baseline

  7. Testosterone Level

    Time frame: Baseline

  8. Lactate Dehydrogenase (LDH) Level

    Time frame: Baseline

  9. Alkaline Phosphatase (ALP) Level

    Time frame: Baseline

  10. Real-World Progression Free Survival (rwPFS)

    Time frame: Up to approximately 3 years

    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.

  11. Median rwPFS

    Time frame: Up to approximately 3 years

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

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

    Time frame: Baseline

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

    Time frame: Up to approximately 3 years

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

    Time frame: Up to approximately 3 years

  15. Proportion of Patients With a Dose Modification

    Time frame: Up to approximately 3 years

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

  16. Time-to-First Dose Modification

    Time frame: Up to approximately 3 years

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

  17. Proportion of Patients who Discontinue Treatment

    Time frame: Up to approximately 3 years

  18. Proportion of Patients who Switch Treatment

    Time frame: Up to approximately 3 years

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

  19. Time-to-Treatment Discontinuation (TTD1L)

    Time frame: Up to approximately 3 years

  20. Time-to-Next Treatment (TTNT)

    Time frame: Up to approximately 3 years

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

  21. Proportion of Patients With Adverse Events

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

  22. Proportion of Patients With Safety Topics of Interest (STIs)

    Time frame: Up to approximately 3 years

    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.

  23. Proportion of Prescriptions by Type of Specialty

    Time frame: Baseline, up to approximately 3 years

  24. Proportion of Prescriptions by Type of Practice Setting

    Time frame: Baseline, up to approximately 3 years

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

    Time frame: Baseline

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

    Time frame: Up to approximately 3 years

Study contacts

Contact information is provided by the study sponsor or research team.

Novartis Pharmaceuticals

CONTACT

[email protected]

+41613241111

Novartis Pharmaceuticals

CONTACT

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Acronym: PRISM

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 13, 2026
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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