Clinical trial NCT03896984: Descriptive Analysis of Clinical Outcomes in Patients With Prostate Gland Cancer, Which Spreads to Other Parts of the Body, Who Were Treated First With Novel Anti-hormone Therapy Followed by a Second Line Treatment With Novel Anti-Hormone Therapy or RadIum-223 (Xofigo).
Official title: DescriPtive Analysis of Real-world Clinical Outcomes of Second Line (2L) Novel Anti-HormonE Therapy (NAH) or RadIum-223 (Xofigo) in Patients With Metastatic Castration Resistance Prostate Cancer (mCRPC) After First Line (1L) NAH Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Castration-resistant Prostate Cancer (mCRPC)
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2019-04-01
Enrollment: 346
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The primary study population consists of patients with documented mCRPC who either received Ra-223 or sequential NAH therapy after 1L NAH therapy respectively.

Brief summary: In this study researcher want to learn more about the overall survival in patients suffering from prostate gland cancer which spread outside the prostate to other parts of the body who received either a novel anti-hormone therapy (NAH) or Radium-223 (Xofigo) after a prior NAH therapy (first line treatment). Additionally the researchers are also interested in the occurrence of bone fractures and other skeletal events. Basis for this study will be the US based Flatiron database which provides access to clinical data for cancer patients.


Eligibility criteria: Inclusion Criteria:

* Patients with documented mCRPC receiving 1L NAHs.
* Initiation of Ra-223 after 1L NAH therapy, or
* Initiation of sequential NAH therapy after 1L NAH therapy

Exclusion criteria:

* Patients involved in clinical trials
* Patients who received combined therapies in 1L or 2L

Primary outcomes:
measure: Overall survival (OS) from initiation of 2L therapy of Radium-223 in patients with mCRPC after 1L NAH therapy
timeFrame: Retrospective analysis from 2013-01-01 to 2018-12-30
measure: Overall survival (OS) from initiation of 2L therapy of sequential NAH in patients with mCRPC after 1L NAH therapy
timeFrame: Retrospective analysis from 2013-01-01 to 2018-12-30
Secondary outcomes:
measure: Descriptive analysis of patient demography at baseline
timeFrame: Retrospective analysis from 2013-01-01 to 2018-12-30
measure: Descriptive analysis of clinical characteristics of patients at baseline
timeFrame: Retrospective analysis from 2013-01-01 to 2018-12-30
measure: Descriptive analysis of laboratory values at baseline
timeFrame: Retrospective analysis from 2013-01-01 to 2018-12-30
measure: Frequency of SSEs of Radium-223 versus Abiraterone or Enzalutamide after 2L
timeFrame: Retrospective analysis from 2013-01-01 to 2018-12-30
measure: Incidence rate of SSEs of Radium-223 versus Abiraterone or Enzalutamide after 2L
timeFrame: Retrospective analysis from 2013-01-01 to 2018-12-30
measure: Frequency of pathologic fracture of Radium-223 versus Abiraterone or Enzalutamide after 2L
timeFrame: Retrospective analysis from 2013-01-01 to 2018-12-30
measure: Incidence rate of pathologic fracture of Radium-223 versus Abiraterone or Enzalutamide after 2L
timeFrame: Retrospective analysis from 2013-01-01 to 2018-12-30
measure: Period of time from initiation of 2L to first SSE
timeFrame: Retrospective analysis from 2013-01-01 to 2018-12-30
Other outcomes:
Locations:
city: Whippany
country: United States
facility: US Flatiron prostate cancer database
state: New Jersey
Study officials:
References:
citation: Sartor O, George D, Tombal B, Agarwal N, Higano CS, Sternberg CN, Miller K, Jiao X, Guo H, Sandstrom P, Bruno A, Verholen F, Saad F, Shore N. Real-world outcomes of second novel hormonal therapy or radium-223 following first novel hormonal therapy for mCRPC. Future Oncol. 2022 Jan;18(1):35-45. doi: 10.2217/fon-2021-0886. Epub 2021 Oct 12.