An observational study in Prostatic Neoplasms, sponsored by Bayer. Completed at 1 site in Sweden. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-02-12.
Sponsored by Bayer · Observational
This study is conducted to obtain information about prostate cancer patients with bone metastases before the end of 2013. The incidence of second primary malignancies and overall survival in patients with castration resistant prostate cancer are of particular interest. Information from this study will serve as a historical reference for the REASSURE study (Background incidence study)
Prostate cancer (PC) is the most common non-cutaneous malignancy in men. Once it becomes metastatic, it poses a serious threat to the patients' quality of life and survival. The most common site of metastases is the skeletal system: Among castration-resistant prostate cancer patients bone metastases are involved in over 90% of metastatic cases.
The development of new treatments has led to improved quality of life and prolonged lifetime among castration-resistant prostate cancer patients with metastases (mCRPC). A recent randomized clinical trial indicated significant improvement in survival and quality of life among patients with bone metastases treated with alpha emitter radium-223 as compared with placebo. To further evaluate the safety profile of Radium-223 in patients with castration resistant prostate cancer with bone metastases, Radium-223 alpha Emitter Agent in non-intervention Safety Study in mCRPC popUlation for long-teRm Evaluation (the REASSURE study), an international prospective observational single-arm cohort study was implemented as a post-marking requirement requested by the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA).
In the case that new treatments improve the length and quality of life substantially, it can be challenging to obtain an appropriate comparison group in the post-authorization phase. This study is conducted to obtain information about prostate cancer patients with bone metastases before the end of 2013. The incidence of second primary malignancies and overall survival are of particular interest. Information from this study will serve as a historical reference for the REASSURE study
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 15,953 is above the median of 200 across 1,181 observational studies indexed under Prostatic Neoplasms.
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Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients with PC diagnosis in 1.1.1998 - 31.12.2013 and with bone metastases diagnosis or bone-directed treatments in 1.1.1998 - 31.12.2013 will be initially included into the large study population. From this initial population, the main analyses will concentrate on the following two populations:
Inclusion Criteria:mPC population; if the following criteria are fulfilled:
A.) PC diagnosis in 1.1.1998 - 31.12.2011 B.) Bone metastases diagnosis in 1.1.1999 - 31.12.2011 mCRPC population; if the following criteria are fulfilled:
One of the following in 1.1.2006 - 31.12.2011 and before or at the same time with bone metastases diagnosis:
Exclusion Criteria:
Prostate cancer patients with bone metastases (mPC)
Castration-resistant prostate cancer patients with bone metastases (mCRPC)
Incidences of Second primary malignancies that are characterized by the following ICD-10 codes: C00-C76, C81-C96, D00-D09, D37-D48.
Time frame: Up to 15 years
Incidences of any site-specific second primary malignancies
Site-specific ICD-10 code groups from the range of all neoplasm codes C00 - D48
Time frame: Up to 15 years for mPC patients and up to 7 years for mCRPC patients
Overall survival
Time frame: Up to 15 years for mPC patients and up to 7 years for mCRPC patients
Pathologic fracture
ICD-10 codes: M49.5, M84.4, M90.7
Time frame: Up to 15 years for mPC patients and up to 7 years for mCRPC patients
Spinal cord compression
ICD-10 codes: M43.9, M48.5, G95.2, G95.8
Time frame: Up to 15 years for mPC patients and up to 7 years for mCRPC patients
Surgery to bone
Based on the Nordic Medico-Statistical Committee (NOMESCO) classification of surgical procedure codes (NCSP codes)
Time frame: Up to 15 years for mPC patients and up to 7 years for mCRPC patients
Radiation to bone
Based on NCSP codes
Time frame: Up to 15 years for mPC patients and up to 7 years for mCRPC patients
This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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