Navigant Study- Treatment Patterns in mCRPC (Metastatic Castrate Resistant Prostate Cancer ) (Navigant)

Current Management, Treatment Patterns and Outcomes of Metastatic Castrate Resistant Prostate Cancer Patients Treated With Radium-223

Categorize the clinical parameters and patient determinants that drive physician decision making for treatment selection including Radium-223 for patients with mCRPC.

Study Overview

• Status: Completed
• Conditions: Prostatic Neoplasms, Castration-Resistant
• Intervention / Treatment: Drug: Xofigo (Radium-223 dichloride, BAY88-8223)

Detailed Description

This is a chart review of 200 Xofigo patients to describe sequencing and characterize clinical parameters and patient determinants that drive physician decision making.

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Whippany, New Jersey, United States, 07981
      • Whippany

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

mCRPC patients treated with Xofigo from 10 centers in the US

Description

Inclusion Criteria:

• Patients were diagnosed with bone metastatic castration-resistant prostate cancer (mCRPC) per medical chart.
• Patients were at least 18 years of age as of the first diagnosis for mCRPC.
• Patients must have received at least one intravenous injection of Radium-223 (Xofigo).

• First injection of Radium-223 must have started between periods

  1-January-2014 to 30-June-2014 or 15-November-2014 to present.

• Patients must have a minimum of 12 months documented follow-up records following last Radium-223 treatment or death within 12 months of last dose.

Exclusion Criteria:

• Patients who received Radium-223 as part in an interventional clinical trial
• Actively treated, or expect to be treated, in 6 months before last follow-up, for any other malignancy with the exception of non-metastatic skin cancer or low-grade superficial bladder cancer.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Radium-223 dichloride; Patients were diagnosed with bone metastatic castration-resistant prostate cancer (mCRPC), at least 18 years of age, must have received at least one intravenous injection of Radium-223.	Drug: Xofigo (Radium-223 dichloride, BAY88-8223); Xofigo is indicated for the treatment of patients with castration-resistant prostate cancer (CRPC), symptomatic bone metastases and no known visceral metastatic disease.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determining factors that drive physician decision for treatment selection.	The treating physician should select out of the following options: Prostate Specific Antigen rising, Alkaline phosphatase (ALP) , Lactate dehydrogenase (LHD), testosterone, pain, symptoms, bone lesions, disease progression.	Up to 9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Most common treatment sequences	Description of what treatments are given to treat mCRPC in first, second, third, and fourth line.	Up to 9 months
Integration of Xofigo into the common treatment sequences, monotherapy or in combination.	Describe where is Xofigo given in the treatment paradigm, whether is given in combination with hormonals or chemotherapy or given as a monotherapy	Up to 9 months
Mean Xofigo dose	Mean dose of each treatment received in the respective sequence	Up to 9 months
Duration of Xofigo treatment	Mean number of treatment cycles	Up to 9 months
Overall survival (OS)	Collect outcomes for patients following treatment for mCRPC including changes in overall survival	Up to 9 months
Time to radiographic progression	Collect outcomes for patients following treatment for mCRPC including changes in time to radiographic progression	Up to 9 months
Time to PSA (Prostate specific antigen) progression	Collect outcomes for patients following treatment for mCRPC including changes in PSA progression	Up to 9 months
Most common SRE (Skeletal Related Event)	The SRE occurring in the highest number of participants will be described.	Up to 9 months
Most common clinical intervention	Most common clinical intervention to treat SRE/SSEs such as radiation or bone surgery.	Up to 9 months
Time to first SSE(Symptomatic Skeletal Events)	Time to first SSE outcome will be analysed using the Kaplan Meier method	Up to 9 months
Reasons for discontinuation	The treating physician should select out of the following options: Prostate Specific Antigen rising, Alkaline phosphatase (ALP) , Lactate dehydrogenase (LHD)), testosterone, pain, symptoms, bone lesions, disease progression.	Up to 9 months
Change in laboratory values from baseline	for hemoglobin, platelets, neutrophils	Up to 9 months
Radiological progression free survival (rPFS)	change in laboratory values from baseline for radiological progression free survival (rPFS)	Up to 9 months
Time to alkaline phosphatase (ALP) progression	change in laboratory values from baseline for ALP	Up to 9 months
Time to visceral metastasis	time from baseline to the appearance of visceral metastasis	Up to 9 months
Time to onset of first subsequent treatment	or start of any other treatment for mCRPC	Up to 9 months
Pain	Based on chart reported pain	Up to 9 months
Most common symptoms	The participant and the treating physician should select out of the following list: fatigue, hypertension, cognitive disorder, seizures, edema, hypokalemia, cardiac disorders, hepatotoxicity, anemia, neutropenia, febrile neutropenia, thrombocytopenia	Up to 9 months
Type of physician	Define type of physicians that treat of mCRPC	Up to 9 months
Change in PSA from baseline to 12 weeks, and baseline to discontinuation	Measure PSA closed to the time of Xofigo initiation, 12 weeks after initiation and after discontinuation	Baseline and 12 weeks,Baseline and through study completion, an average of 1 year
Resource utilization	Number of outpatient, inpatient and emergency room visits as well as number of hospitalizations	Up to 9 months
Change in ALP from baseline to 12 weeks, and baseline to discontinuation	Measure ALP closed to the time of Xofigo initiation, 12 weeks after initiation and after discontinuation	Baseline and 12 weeks,Baseline and through study completion, an average of 1 year
Change in LDH from baseline to 12 weeks, and baseline to discontinuation	Measure LDH values closed to the time of Xofigo initiation, 12 weeks after initiation and after discontinuation	Baseline and 12 weeks,Baseline and through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2017
• Primary Completion (Actual): March 31, 2019
• Study Completion (Actual): March 31, 2019

Study Registration Dates

• First Submitted: July 19, 2016
• First Submitted That Met QC Criteria: September 8, 2016
• First Posted (Estimate): September 14, 2016

Study Record Updates

• Last Update Posted (Actual): March 31, 2020
• Last Update Submitted That Met QC Criteria: March 30, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Prostatic Neoplasms, Castration-Resistant; Antineoplastic Agents; Radium Ra 223 dichloride
• Other Study ID Numbers: 18919

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No