check_circleStudy Completed
Prostatic Neoplasm
Bayer Identifier:
18695
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Treatment Patterns in Metastatic Prostate Cancer
Trial purpose
This study will evaluate treatment patterns, mortality, healthcare resource utilization, and costs in patients with prostate cancer with bone metastases (primary objectives). Additionally, this study will evaluate opioid/analgesic use among lines of therapy in this patient population (secondary objective). The study is descriptive in nature and is meant to provide a greater understanding of the patterns of therapy observed in real-world clinical practice (in the absence of clear guideline recommendations with regards to treatment sequencing), to contribute to a greater understanding of the major cost drivers (thus better-informing payers), and to examine real-world mortality in such patients.
Key Participants Requirements
Sex
MaleAge
45 - N/ATrial summary
Enrollment Goal
565Trial Dates
October 2016 - January 2017Phase
N/ACould I Receive a placebo
NoProducts
N/AAccepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Whippany, United States |
Primary Outcome
- Distribution of treatment types among lines of therapyPossible Treatment Types: Sipuleucel-T, Abiraterone, Enzalutamide, Docetaxel, Cabazitaxel, Radium-223, Anti-Androgens, All other chemotherapy(oral and injectables), Radiation therapydate_rangeTime Frame:Up to 6 monthsenhanced_encryptionNoSafety Issue:
- Time to treatment (days)date_rangeTime Frame:Up to 6 monthsenhanced_encryptionNoSafety Issue:
- Duration of treatment (days)date_rangeTime Frame:Up to 6 monthsenhanced_encryptionNoSafety Issue:
- Number of patients on each drug or drug combinationDrug: Sipuleucel-T, Abiraterone, Enzalutamide, Docetaxel, Cabazitaxel, Radium-223, Anti-Androgens, All other chemotherapy(oral and injectables), Radiation therapydate_rangeTime Frame:Up to 6 monthsenhanced_encryptionNoSafety Issue:
- Number of inpatient visits per patientdate_rangeTime Frame:Upto 6 month post index periodenhanced_encryptionNoSafety Issue:
- Length of hospital stay (days) among those with an inpatient visitdate_rangeTime Frame:Upto 6 month post index periodenhanced_encryptionNoSafety Issue:
- Number of outpatient visits per patientdate_rangeTime Frame:Upto 6 month post index periodenhanced_encryptionNoSafety Issue:
- Number of emergency room (ER) visits per patientdate_rangeTime Frame:Upto 6 month post index periodenhanced_encryptionNoSafety Issue:
- Number of physician office visits per patientdate_rangeTime Frame:Upto 6 month post index periodenhanced_encryptionNoSafety Issue:
- Number of medication prescriptions per patientdate_rangeTime Frame:Upto 6 month post index periodenhanced_encryptionNoSafety Issue:
- Number of patients by provider typedate_rangeTime Frame:Upto 6 month post index periodenhanced_encryptionNoSafety Issue:
- Number of claims per patientdate_rangeTime Frame:Upto 6 month post index periodenhanced_encryptionNoSafety Issue:
- Total costs of healthcaredate_rangeTime Frame:Upto 6 month post index periodenhanced_encryptionNoSafety Issue:
- Medical costs of healthcaredate_rangeTime Frame:Upto 6 month post index periodenhanced_encryptionNoSafety Issue:
- Pharmacy costs of healthcaredate_rangeTime Frame:Upto 6 month post index periodenhanced_encryptionNoSafety Issue:
- Per-patient-per-month (PPPM)) costs of healthcaredate_rangeTime Frame:Upto 6 month post index periodenhanced_encryptionNoSafety Issue:
- Mortality ratedate_rangeTime Frame:Up to 6 monthsenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Opioid/analgesic use among lines of therapy(Y/N)Opioid and analgesics use among lines of therapy (e.g. 1st, 2nd, 3rd)date_rangeTime Frame:Up to 6 monthsenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A