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NCT Number: NCT07677267

A Study of Real-World Characteristics, Treatment Patterns, and Outcomes Among mCRPC Patients Previously Treated With an Androgen Receptor Pathway Inhibitor, Taxane-Based Chemotherapy, and Lutetium-177 Vipivotide Tetraxetan

The aim of this study is to assess treatment patterns, characteristics, and clinical outcomes among adults with metastatic castration-resistant prostate cancer (mCRPC) who have previously received ≥1 androgen receptor pathway inhibitor (ARPI), ≥1 taxane, and 177Lu-PSMA-617 in the United States (US) real-world clinical practice. This study will be conducted using data extracted from the PRECISION (PRostatE Cancer dISease observatION) data platform.

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Key information

Conditions

Prostatic Neoplasms, Castration-Resistant Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–115 year

Sex eligibility

Male

Study type

Observational

Primary location

Novartis

East Hanover, New Jersey, 07936, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Evidence of 177Lu-PSMA-617 use on or after 01 January 2021.
  • Evidence of treatment with ≥1 ARPI, before 177Lu-PSMA-617.
  • Evidence of treatment with ≥1 taxane, before or after 177Lu-PSMA-617.
  • Diagnosis of mCRPC prior to or on the index date. The index date is the date of the last treatment administration of the latest of an ARPI, taxane, and 177Lu-PSMA-617.
  • Age ≥18 years at index.

Exclusion criteria

  • None.

Treatment and study plan

Primary outcomes

  1. Number of Patients by Number of Lines of Therapy (LOTs) Between mCRPC Diagnosis and Index Date

    Time frame: Baseline

    The index date is the date of the last treatment administration of the latest of an ARPI, taxane, and 177Lu-PSMA-617.

  2. Number of Patients by Number and Type of Prior Therapies Indicated for Advanced Prostate Cancer (PC)

    Time frame: Baseline

    Number of patients by number and type of prior ARPI, taxane, 177Lu-PSMA-617, and other therapies indicated for advanced PC.

  3. Number of Patients by Number of Prostate-specific Membrane Antigen (PSMA) Scans

    Time frame: Baseline up to approximately 5 years

  4. Number of Patients by Timing of PSMA Scans

    Time frame: Baseline up to approximately 5 years

    Timing of scans is categorized as pre-mCRPC diagnosis, post-mCRPC diagnosis but pre-index date, and post-index date. The index date is the date of the last treatment administration of the latest of an ARPI, taxane, and 177Lu-PSMA-617.

  5. Number of Patients by Number of Post-index LOTs

    Time frame: Up to approximately 5 years

  6. Number of Patients by Type of Therapy at Each Post-index LOT

    Time frame: Up to approximately 5 years

  7. Time From Index Date to Next Therapy Initiation

    Time frame: Up to approximately 5 years

    The index date is the date of the last treatment administration of the latest of an ARPI, taxane, and 177Lu-PSMA-617.

Secondary outcomes

  1. Number of Patients by Patient Characteristics

    Time frame: Baseline

    Patient characteristics include race, geographical region, insurance status, marital status, type of treatment center, comorbidities, Gleason score, disease stage at diagnosis, and prostate-specific antigen (PSA) level.

  2. Age

    Time frame: Baseline

  3. Progression-free Survival (PFS) From Index Date

    Time frame: Up to approximately 5 years

    Time from the applicable index date until progression or death from any cause. The index date is the date of the last treatment administration of the latest of an ARPI, taxane, and 177Lu-PSMA-617.

  4. PFS From Initiation of First Post-index Therapy, in Patients With ≥1 Post-index Therapy

    Time frame: Up to approximately 5 years

    Time from the initiation of first post-index therapy until progression or death from any cause.

  5. Overall Survival (OS) From Index Date

    Time frame: Up to approximately 5 years

    Time from the applicable index date until death from any cause. The index date is the date of the last treatment administration of the latest of an ARPI, taxane, and 177Lu-PSMA-617.

  6. OS From Initiation of First Post-index Therapy, in Those With ≥1 Post-index Therapy

    Time frame: Up to approximately 5 years

    Time from initiation of first post-index therapy until death from any cause.

  7. Among Patients With ≥1 Post-index Therapy, Number of Patients With a Reduction in PSA Level

    Time frame: Up to approximately 5 years

    Reduction in PSA level categorized as follows:

    • ≥50% (PSA50) reduction in PSA level
    • ≥80% (PSA80) reduction in PSA level
    • ≥90% (PSA90) reduction in PSA level

  8. Among Patients With ≥1 Post-index Therapy, Number of Patients With PSA <0.2 ng/mL on First Post-index Therapy

    Time frame: Up to approximately 5 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 Characteristics, Treatment Patterns, and Outcomes Among Adults With mCRPC Previously Treated With an Androgen Receptor Pathway Inhibitor, Taxane-Based Chemotherapy, and Lutetium-177 Vipivotide Tetraxetan

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 30, 2026
Registry last updated
Jul 16, 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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