NCT07677267

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
1,067

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 Progress22%
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

Prostatic Neoplasms, Castration-Resistant

Keywords

Metastatic Castration-Resistant Prostate CancerAndrogen Pathway Modulation-ResistantAPMR

Outcome Measures

Primary Outcomes (7)

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

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

    Baseline

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

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

    Baseline

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

    Baseline up to approximately 5 years

  • Number of Patients by Timing of PSMA Scans

    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.

    Baseline up to approximately 5 years

  • Number of Patients by Number of Post-index LOTs

    Up to approximately 5 years

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

    Up to approximately 5 years

  • Time From Index Date to Next Therapy Initiation

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

    Up to approximately 5 years

Secondary Outcomes (8)

  • Number of Patients by Patient Characteristics

    Baseline

  • Age

    Baseline

  • Progression-free Survival (PFS) From Index Date

    Up to approximately 5 years

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

    Up to approximately 5 years

  • Overall Survival (OS) From Index Date

    Up to approximately 5 years

  • +3 more secondary outcomes

Study Arms (3)

Overall mCRPC Cohort

Adult patients with a diagnosis of mCRPC and evidence of prior treatment with ≥1 ARPI, ≥1 taxane, and 177Lu-PSMA-617 in PRECISION.

mCRPC Progression Subgroup

A subgroup of the Overall mCRPC Cohort. Patients with evidence of progression on or after 177Lu-PSMA-617 treatment.

≥1 Subsequent Systemic Therapy Subgroup

A subgroup of the Overall mCRPC Cohort. Patients who initiate ≥1 post-index systemic therapy.

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 diagnosis of mCRPC and evidence of prior treatment with ≥1 ARPI, ≥1 taxane, and 177Lu-PSMA-617 in the PRECISION data platform.

You may qualify if:

  • 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.

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

+41613241111novartis.email@novartis.com

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

US(1)