Trials Sponsors Conditions Drugs Pricing

Conditions

Prostate Cancer

Keywords

Metastatic castrate-resistant prostate cancerTreatment patternsTreatment responseOverall survival

Outcome Measures

Primary Outcomes (7)

Number of Patients by Demographic Category
Demographics included: * Age group * Geographical region * Payer type * Physician specialty * Race/ethnicity * Education level * Occupation
Baseline
Number of Patients by Clinical Characteristic Category
Clinical characteristics included: * National Cancer Institute (NCI) comorbidity index * NCI category * Comorbidities * Metastasis sites * Number of distinct metastatic sites * PSA level category (≤ 4 ng/ml, \> 4 ng/ml)
Baseline
Clinical Characteristic: Baseline PSA Level
Baseline
Overall Survival (OS)
OS was defined as the time from mCRPC diagnosis until death.
Up to approximately 10 years
Number of Patients who Died Within 6, 12, 24, and 36 Months From the mCRPC Diagnosis Date
6, 12, 24, and 36 months

Secondary Outcomes (10)

Percentage of Patients by Treatments Received From mCRPC Diagnosis to Initiation of 177Lu-PSMA-617
Up to approximately 10 years
Percentage of Patients by Line of 177Lu-PSMA-617 Initiation
Up to approximately 10 years
Percentage of Patients by Sequence of Treatments Prior to 177Lu-PSMA-617 Treatment
Baseline
Duration of Each Line of Treatment (LOT) by Treatment Received
Up to approximately 10 years
Time From mCRPC Diagnosis to Initiation of 177Lu-PSMA-617
Up to approximately 10 years
+5 more secondary outcomes

Study Arms (4)

177Lu-PSMA-617 Patients Meeting Minimum Study Criteria

Phase I analysis group. Adult patients treated with 177Lu-PSMA-617 who met the minimum study criteria.

177Lu-PSMA-617 Patients with Pre- and Post-PSA Data Available

Phase I analysis group. Adult patients who met the minimum study criteria and had at least one PSA result available 28 days or more after the index date (177Lu-PSMA-617 initiation) while still on 177Lu-PSMA-617 treatment.

Patients who Received 177Lu-PSMA-617 at Anytime During the Study Period

Phase II analysis group. Adult patients with mCRPC who initiated 177Lu-PSMA-617 between 01 July 2014 and 30 September 2024 (index period).

Post-mCRPC 177Lu-PSMA-617 (≥6 Months Continuous Enrollment)

Phase II analysis group. Adult patients with continuous enrollment (CE) between the mCRPC diagnosis date and initiating 177Lu-PSMA-617 (index date), and at least 6 months of CE prior to the index date.

Eligibility Criteria

Age18 Years+

Sexmale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Patients with electronic health care records in multiple databases who were treated with 177Lu-PSMA-617.

You may qualify if:

Patients with ≥1 claim in the open-source medical claims data with a Healthcare Common Procedure Coding System (HCPCS) code of A9607 or ≥1 claim in the open-source medical or pharmacy claims data with a National Drug Code (NDC) code for 177Lu-PSMA-617 during the patient selection window. The date of the first such claim is the index date.

Sponsors & Collaborators

Novartis Pharmaceuticals
Industrylead

Study Sites (1)

Novartis

East Hanover, New Jersey, 07936, United States

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

Novartis Pharmaceuticals
Novartis Pharmaceuticals
STUDY DIRECTOR

Enrollment

6,448 participants (actual enrollment reported by the registry).

Study Design

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

Study Record Dates

First Submitted

February 27, 2026

First Posted

March 4, 2026

Study Start

June 23, 2023

Actual (reported)

A Study of Patient Characteristics, Treatment Patterns and Outcomes Among Patients Treated With 177Lu-PSMA-617

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (7)

Secondary Outcomes (10)

Study Arms (4)

177Lu-PSMA-617 Patients Meeting Minimum Study Criteria

177Lu-PSMA-617 Patients with Pre- and Post-PSA Data Available

Patients who Received 177Lu-PSMA-617 at Anytime During the Study Period

Post-mCRPC 177Lu-PSMA-617 (≥6 Months Continuous Enrollment)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (7)

Secondary Outcomes (10)

Study Arms (4)

177Lu-PSMA-617 Patients Meeting Minimum Study Criteria

177Lu-PSMA-617 Patients with Pre- and Post-PSA Data Available

Patients who Received 177Lu-PSMA-617 at Anytime During the Study Period

Post-mCRPC 177Lu-PSMA-617 (≥6 Months Continuous Enrollment)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations