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NCT Number: NCT07677254

A Study of Real-World Characteristics, Treatment Patterns, and Clinical Outcomes in Patients With Metastatic Castration-Resistant Prostate Cancer

The aim of this study is to assess treatment patterns, clinical outcomes, and patient characteristics among adults with metastatic castration-resistant prostate cancer (mCRPC) 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

  • Diagnosis of mCRPC between 01 January 2021 and 31 December 2025.
  • Male sex at index, where index is the date of initial mCRPC diagnosis.
  • Age 18 years at index.

Exclusion criteria

  • None

Treatment and study plan

Primary outcomes

  1. Number of Patients by Prior Therapies

    Time frame: Baseline

  2. Number of Patients by Number of Post-index Lines of Therapy (LOTs)

    Time frame: Up to approximately 5 years

  3. Number of Patients by Type of Therapy at Each LOT

    Time frame: Up to approximately 5 years

  4. Percentage of Patients Switching From One Type of Therapy to Another at Each LOT

    Time frame: Up to approximately 5 years

  5. Time to First-line (1L) Treatment Initiation (TTTI)

    Time frame: Up to approximately 5 years

    Time from index date (mCRPC diagnosis) to the start of 1L treatment.

  6. Time to Next Therapy (TTNT) for Each LOT

    Time frame: Up to approximately 5 years

    Time from the end of each LOT to initiation of the next LOT.

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

    PFS from index date: time from mCRPC diagnosis (index date) until progression or death from any cause.

  4. PFS From Each LOT

    Time frame: Up to approximately 5 years

    PFS from each LOT, among those with that LOT: time from the date of initiation of the LOT until progression or death from any cause.

  5. Overall Survival (OS) From Index Date

    Time frame: Up to approximately 5 years

    OS from index date: time from mCRPC diagnosis (index date) until death from any cause.

  6. OS From Each LOT

    Time frame: Up to approximately 5 years

    OS from each LOT, among those with that LOT: time from the date of initiation of the LOT until death from any cause.

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 Clinical Outcomes in Contemporary Patients With Metastatic Castration-Resistant Prostate Cancer in the PRECISION Data Platform

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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