Recruiting

mCRPC

Sponsor:

Novartis Pharmaceuticals

Code:

NCT07677267

Conditions

Prostatic Neoplasms, Castration-Resistant

Eligibility Criteria

Sex: Male

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Prostatic Neoplasms, Castration-Resistant

Study ID

NCT07677267

Start date

Jun 30, 2026

Status verified date

Jul, 2026

Completion date

Nov 30, 2026

Anticipated

Primary completion date

Nov 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

1067 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • Number of Patients by Number of Lines of Therapy (LOTs) Between mCRPC Diagnosis and Index Date [ Time Frame: Baseline ]
  • Number of Patients by Number and Type of Prior Therapies Indicated for Advanced Prostate Cancer (PC) [ Time Frame: Baseline ]
  • Number of Patients by Number of Prostate-specific Membrane Antigen (PSMA) Scans [ Time Frame: Baseline up to approximately 5 years ]
  • Number of Patients by Timing of PSMA Scans [ Time Frame: Baseline up to approximately 5 years ]
  • Number of Patients by Number of Post-index LOTs [ Time Frame: Up to approximately 5 years ]
  • Number of Patients by Type of Therapy at Each Post-index LOT [ Time Frame: Up to approximately 5 years ]
  • Time From Index Date to Next Therapy Initiation [ Time Frame: Up to approximately 5 years ]

Central Contacts and Locations

Central contacts

Novartis Pharmaceuticals

+41613241111novartis.email@novartis.com

Locations

Novartis

Recruiting

East Hanover, New Jersey, United States, 07936

More Information

Sponsor

Novartis Pharmaceuticals

Last update posted

Jul 16, 2026

Last verified

Jul, 2026

Keywords

  • Metastatic Castration-Resistant Prostate Cancer
  • Androgen Pathway Modulation-Resistant
  • APMR

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Novartis Pharmaceuticals on 2026-07-16.