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

Prostatic Neoplasms, Castration-Resistant Clinical Trial

— Navigant  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02899104
• Other study ID #: 18919
• Status: Completed
• Start date: June 15, 2017
• Est. completion date: March 31, 2019

Study information

• Verified date: March 2020
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: March 31, 2019
• Est. primary completion date: March 31, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostatic Neoplasms
• Prostatic Neoplasms, Castration-Resistant

Intervention

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.

Locations

Country	Name	City	State
United States	Whippany	Whippany	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Most common treatment sequences	Description of what treatments are given to treat mCRPC in first, second, third, and fourth line.	Up to 9 months
Secondary	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
Secondary	Mean Xofigo dose	Mean dose of each treatment received in the respective sequence	Up to 9 months
Secondary	Duration of Xofigo treatment	Mean number of treatment cycles	Up to 9 months
Secondary	Overall survival (OS)	Collect outcomes for patients following treatment for mCRPC including changes in overall survival	Up to 9 months
Secondary	Time to radiographic progression	Collect outcomes for patients following treatment for mCRPC including changes in time to radiographic progression	Up to 9 months
Secondary	Time to PSA (Prostate specific antigen) progression	Collect outcomes for patients following treatment for mCRPC including changes in PSA progression	Up to 9 months
Secondary	Most common SRE (Skeletal Related Event)	The SRE occurring in the highest number of participants will be described.	Up to 9 months
Secondary	Most common clinical intervention	Most common clinical intervention to treat SRE/SSEs such as radiation or bone surgery.	Up to 9 months
Secondary	Time to first SSE(Symptomatic Skeletal Events)	Time to first SSE outcome will be analysed using the Kaplan Meier method	Up to 9 months
Secondary	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
Secondary	Change in laboratory values from baseline	for hemoglobin, platelets, neutrophils	Up to 9 months
Secondary	Radiological progression free survival (rPFS)	change in laboratory values from baseline for radiological progression free survival (rPFS)	Up to 9 months
Secondary	Time to alkaline phosphatase (ALP) progression	change in laboratory values from baseline for ALP	Up to 9 months
Secondary	Time to visceral metastasis	time from baseline to the appearance of visceral metastasis	Up to 9 months
Secondary	Time to onset of first subsequent treatment	or start of any other treatment for mCRPC	Up to 9 months
Secondary	Pain	Based on chart reported pain	Up to 9 months
Secondary	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
Secondary	Type of physician	Define type of physicians that treat of mCRPC	Up to 9 months
Secondary	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
Secondary	Resource utilization	Number of outpatient, inpatient and emergency room visits as well as number of hospitalizations	Up to 9 months
Secondary	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
Secondary	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

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