A Real-world Study of Characteristics, Treatment Patterns, and Clinical Outcomes Among Lutetium-177 Vipivotide Tetraxetan Treated Patients

NCT07477756 | Completed

• 1 other identifier: CAAA617A1US13
• Study Type: observational
• Target: 1,247
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study was to assess the characteristics, treatment patterns, and clinical outcomes among metastatic castration-resistant prostate cancer (mCRPC) patients in the United States (US) who were treated with lutetium-177 vipivotide tetraxetan (177Lu-PSMA-617) in the real-world setting.

Conditions

Prostate Cancer

Keywords

Lutetium-177 (177Lu) Vipivotide Tetraxetan; 177Lu-PSMA-617; Clinical Outcomes; Prostate Cancer; Prostate-specific Antigen; Metastatic Castration-resistant Prostate Cancer

Outcome Measures

Primary Outcomes (6)

• Number of Patients by Patient Characteristic

  Patient characteristics included: * Age * Race * Marital status * Insurance status * Practice type * Physician specialty * Geographic region * Have a Gleason score ≤1 year of index * Gleason score (\<7, ≥7) * Have a prostate-specific antigen (PSA) test ≤1 year of index * PSA level (elevated, normal, unknown)

  Baseline

• Mean PSA Level

  Baseline

• Number of Patients by Number of ARPIs and Taxanes Received Before 177Lu-PSMA-617 Treatment Initiation

  Baseline

• Number of Patients by Number of Doses of 177Lu-PSMA-617 Treatment From Initiation Until Discontinuation

  Up to approximately 2 years

• Duration of 177Lu-PSMA-617 Treatment

  Up to approximately 2 years

• Number and Percentage of Patients Initiating ARPIs, Taxanes, and Other Guideline-recommended Therapies for mCRPC After 177Lu-PSMA-617 Discontinuation

  Up to approximately 2 years

Secondary Outcomes (1)

• Number and Percentage of Patients With a Reduction in PSA Level

  Baseline up to approximately 2 years

Study Arms (8)

Overall 177Lu-PSMA-617 Cohort

All patients treated with 177Lu-PSMA-617.

Prior Treatment Use Cohort: ≥1 Androgen Receptor Pathway Inhibitor (ARPI) and ≥1 Taxane

Patients treated with 177Lu-PSMA-617 after at least 1 ARPI and at least 1 taxane treatment. ARPIs include abiraterone, enzalutamide, darolutamide, and apalutamide. Taxanes include cabazitaxel and docetaxel.

Prior Treatment Use Cohort: 1 ARPI and 1 Taxane

Patients treated with 177Lu-PSMA-617 after 1 ARPI and 1 taxane treatment. ARPIs include abiraterone, enzalutamide, darolutamide, and apalutamide. Taxanes include cabazitaxel and docetaxel.

Prior Treatment Use Cohort: Delayed

Patients with evidence of 1 ARPI and 1 taxane treatment plus at least 1 additional ARPI or taxane before 177Lu-PSMA-617 initiation. ARPIs include abiraterone, enzalutamide, darolutamide, and apalutamide. Taxanes include cabazitaxel and docetaxel.

Subsequent Treatment Use Cohort: Any Guideline-Recommended Treatment

Patients treated with any guideline-recommended treatment for mCRPC after 177Lu-PSMA-617 discontinuation. Guideline-recommended treatments include abiraterone, enzalutamide, darolutamide, apalutamide, cabazitaxel, docetaxel, pembrolizumab, sipuleucel-T, niraparib, olaparib, talazoparib, rucaparib, radium-223; carboplatin, cisplatin, etoposide, and mitoxantrone.

Subsequent Treatment Use Cohort: ARPI/Taxane

Patients treated with any ARPI or taxane after 177Lu-PSMA-617 discontinuation (i.e., abiraterone, enzalutamide, darolutamide, apalutamide, cabazitaxel, docetaxel).

Subsequent Treatment Use Cohort: ARPI

Patients treated with any ARPI after 177Lu-PSMA-617 discontinuation (i.e., abiraterone, enzalutamide, darolutamide, apalutamide).

Subsequent Treatment Use Cohort: Taxane

Patients treated with any taxane after 177Lu-PSMA-617 discontinuation (i.e., cabazitaxel, docetaxel).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All adult patients with evidence of treatment with 177Lu-PSMA-617.

You may qualify if:

• Evidence of 177Lu-PSMA-617 use on or after March 23, 2022
• Date of initiation of 177Lu-PSMA-617 available in the data
• Age ≥18 years at index

You may not qualify if:

• None

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis

East Hanover, New Jersey, 07936, United States

Location

Related Links

• Link to study results

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: March 12, 2026
• First Posted: March 17, 2026
• Study Start: September 4, 2024
• Primary Completion: March 14, 2025
• Study Completion: March 14, 2025
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)