NCT07677254

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17,111

participants targeted

Target at P75+ for all trials

Timeline
4mo left

Started Jun 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress21%
Jun 2026Nov 2026

First Submitted

Initial submission to the registry

June 24, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 30, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

June 30, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2026

Last Updated

July 16, 2026

Status Verified

July 1, 2026

Enrollment Period

5 months

First QC Date

June 24, 2026

Last Update Submit

July 15, 2026

Conditions

Keywords

Metastatic Castration-Resistant Prostate CancerAndrogen Pathway Modulation-ResistantAPMR

Outcome Measures

Primary Outcomes (6)

  • Number of Patients by Prior Therapies

    Baseline

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

    Up to approximately 5 years

  • Number of Patients by Type of Therapy at Each LOT

    Up to approximately 5 years

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

    Up to approximately 5 years

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

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

    Up to approximately 5 years

  • Time to Next Therapy (TTNT) for Each LOT

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

    Up to approximately 5 years

Secondary Outcomes (6)

  • Number of Patients by Patient Characteristics

    Baseline

  • Age

    Baseline

  • Progression-free Survival (PFS) From Index Date

    Up to approximately 5 years

  • PFS From Each LOT

    Up to approximately 5 years

  • Overall Survival (OS) From Index Date

    Up to approximately 5 years

  • +1 more secondary outcomes

Study Arms (1)

mCRPC Cohort

Adult male patients with a recent diagnosis of mCRPC in PRECISION.

Eligibility Criteria

Age18 Years - 115 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult male patients with a confirmed mCRPC diagnosis in the US in the last 5 years who are included in the PRECISION data platform.

You may qualify if:

  • 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.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis

East Hanover, New Jersey, 07936, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms, Castration-Resistant

Condition Hierarchy (Ancestors)

Prostatic NeoplasmsGenital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

Novartis Pharmaceuticals

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2026

First Posted

June 30, 2026

Study Start

June 30, 2026

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

November 30, 2026

Last Updated

July 16, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations