NCT07677267 · Novartis Pharmaceuticals
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
What this study is about
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.
View original scientific description
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.
Primary outcome measures
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.
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.
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
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.
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
The index date is the date of the last treatment administration of the latest of an ARPI, taxane, and 177Lu-PSMA-617.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- East Hanover, New Jersey
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 16, 2026 · Source of record for eligibility and locations