Treatment Patterns in Metastatic Prostate Cancer

• ClinicalTrials.gov Identifier: NCT02729103
• Recruitment Status: Completed
• First Posted: April 6, 2016
• Last Update Posted: January 25, 2018
• Sponsor: Bayer
• Information provided by (Responsible Party): Bayer

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment
Prostatic Neoplasm	Drug: Xofigo (Radium 223 dichloride,BAY88-8223)

Study Design

• Study Type: Observational
• Actual Enrollment: 565 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Treatment Patterns, Mortality, Healthcare Resource Utilization, and Costs in Patients With Prostate Cancer With Bone Metastases: A Retrospective Database Analysis .
• Actual Study Start Date: October 31, 2016
• Actual Primary Completion Date: January 19, 2017
• Actual Study Completion Date: January 19, 2017

Groups and Cohorts

Group/Cohort	Intervention/treatment
Treatment patterns, healthcare resource utilization and costs; Part 1 - Assessment of treatment patterns, healthcare resource utilization and costs. The study cohort will include all patients with prostate cancer with incident bone metastases during the index period (1 June 2013 to 1 July 2014) based on a large database encompassing a broad sample of the commercially insured U.S. population. The first date of bone metastases diagnosis or first date of treatment indicative of bone metastases (whichever occurs first) will be designated as the index date. All patients must have no diagnosis of other cancers, no diagnosis of bone metastases or a claim for a treatment indicative of bone metastases, and no skeletal-related events (SREs) in the 12-month pre-index period. Additionally, all subjects must be continuously enrolled for at least 12 months before and at least 6 months after the index date.	Drug: Xofigo (Radium 223 dichloride,BAY88-8223); Retrospective claims analysis. Descriptive analyses of treatment patterns.
Mortality; Part 2 - Assessment of mortality. The study cohort will include all patients with prostate cancer with incident bone metastases during the index period (1 June 2013 to 1 July 2014) based on a large database encompassing a broad sample of the commercially insured U.S. population. The first date of bone metastases diagnosis or first date of treatment indicative of bone metastases (whichever occurs first) will be designated as the index date. All patients must have no diagnosis of other cancers, no diagnosis of bone metastases or a claim for a treatment indicative of bone metastases, and no SREs in the 12-month pre-index period. Additionally, all subjects must be continuously enrolled for at least 12 months before the index date. Unlike in Part 1, there will be no required minimum follow-up time after the index date (in order to assess mortality).	Drug: Xofigo (Radium 223 dichloride,BAY88-8223); Retrospective claims analysis. Descriptive analyses of treatment patterns.

Outcome Measures

Primary Outcome Measures :

1. Distribution of treatment types among lines of therapy [ Time Frame: Up to 6 months ]
   Possible Treatment Types: Sipuleucel-T, Abiraterone, Enzalutamide, Docetaxel, Cabazitaxel, Radium-223, Anti-Androgens, All other chemotherapy(oral and injectables), Radiation therapy
2. Time to treatment (days) [ Time Frame: Up to 6 months ]
3. Duration of treatment (days) [ Time Frame: Up to 6 months ]
4. Number of patients on each drug or drug combination [ Time Frame: Up to 6 months ]
   Drug: Sipuleucel-T, Abiraterone, Enzalutamide, Docetaxel, Cabazitaxel, Radium-223, Anti-Androgens, All other chemotherapy(oral and injectables), Radiation therapy
5. Number of inpatient visits per patient [ Time Frame: Upto 6 month post index period ]
6. Length of hospital stay (days) among those with an inpatient visit [ Time Frame: Upto 6 month post index period ]
7. Number of outpatient visits per patient [ Time Frame: Upto 6 month post index period ]
8. Number of emergency room (ER) visits per patient [ Time Frame: Upto 6 month post index period ]
9. Number of physician office visits per patient [ Time Frame: Upto 6 month post index period ]
10. Number of medication prescriptions per patient [ Time Frame: Upto 6 month post index period ]
11. Number of patients by provider type [ Time Frame: Upto 6 month post index period ]
12. Number of claims per patient [ Time Frame: Upto 6 month post index period ]
13. Total costs of healthcare [ Time Frame: Upto 6 month post index period ]
14. Medical costs of healthcare [ Time Frame: Upto 6 month post index period ]
15. Pharmacy costs of healthcare [ Time Frame: Upto 6 month post index period ]
16. Per-patient-per-month (PPPM)) costs of healthcare [ Time Frame: Upto 6 month post index period ]
17. Mortality rate [ Time Frame: Up to 6 months ]

Secondary Outcome Measures :

1. Opioid/analgesic use among lines of therapy(Y/N) [ Time Frame: Up to 6 months ]
   Opioid and analgesics use among lines of therapy (e.g. 1st, 2nd, 3rd)

Eligibility Criteria

• Ages Eligible for Study: 45 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Part 1 - Assessment of treatment patterns, healthcare resource utilization, and costs The study cohort will include all patients with prostate cancer with incident bone metastases during the index period (1 June 2013 to 1 July 2014) based on a large database encompassing a broad sample of the commercially insured U.S. population. The first date of bone metastases diagnosis or first date of treatment indicative of bone metastases (whichever occurs first) will be designated as the index date.

Part 2 - Assessment of mortality The study cohort will include all patients with prostate cancer with incident bone metastases during the index period (1 June 2013 to 1 July 2014) based on a large database encompassing a broad sample of the commercially insured U.S. population. The first date of bone metastases diagnosis or first date of treatment indicative of bone metastases (whichever occurs first) will be designated as the index date.

Criteria

Inclusion Criteria:

- Subjects with at least one claim with a primary diagnosis of prostate cancer (International Classification of Diseases(ICD) Clinical Modification (CM)185.xx )and any of the below on same day or after the prostate cancer claim:

• At least one inpatient claim with a primary or secondary diagnosis indicating bone metastases (ICD 9 CM 198.5 or Healthcare Common Procedure Coding System (HCPCS) code for a treatment indicative of bone metastases OR
• At least two outpatient claims with a primary or secondary diagnosis indicating bone metastases (ICD 9 CM 198.5 or HCPCS code for a treatment indicative of bone metastases, with a minimum of 30 days between claims.

Exclusion Criteria:

• Subjects with a diagnosis of a cancer other than prostate cancer - defined as the presence of one inpatient or two outpatient claims with a primary or secondary diagnosis of malignant neoplasms (ICD-9-CM 140.xx-171.xx, 174.xx-184.xx,186.xx-195.xx,200.xx-209.3x, 230.xx-239.xx) - in the 12-month pre-index period.
• Subjects with any claim for a primary or secondary diagnosis indicating bone metastases (ICD-9-CM 198.5) or any treatment indicative of bone metastases in the 12-month pre-index period.
• Patients who had a SRE in the 12-month pre-index period.
• Subjects without continuous enrollment for at least 12 months before the index date.
• Subjects without continuous eligibility for at least 6 months after the index date.
• Subjects that are female.
• Subjects that have negative costs.
• Subjects that are less than 45 years of age on the index date.

Contacts and Locations

Locations

United States, New Jersey

Whippany, New Jersey, United States

Sponsors and Collaborators

Bayer

Investigators

• Study Director: Bayer Study Director; Bayer

More Information

Additional Information:

Click here to find results for studies related to Bayer products. 

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT02729103
• Other Study ID Numbers: 18695
• First Posted: April 6, 2016
• Last Update Posted: January 25, 2018
• Last Verified: January 2018

Additional relevant MeSH terms:

Prostatic Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Prostatic Diseases; Radium Ra 223 dichloride; Antineoplastic Agents