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).
NCT ID: NCT03896984
Last Updated: 2021-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
346 participants
OBSERVATIONAL
2019-03-18
2020-12-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Cohort_2LX
Patients with mCRPC who received NAH monotherapy (Abiraterone or Enzalutamide) as first liine (1L) after diagnosis of mCRPC who then received Ra-223 monotherapy as second line (2L) treatment
Radium-223 (Xofigo, BAY88-8223)
Ra-223 was approved by the FDA in May 2013 for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease.
Abiraterone
Abiraterone is a CYP17 inhibitor. It was approved by the FDA for the treatment of patients with mCRPC in 2011, and for patients with metastatic high-risk castration-sensitive prostate cancer in 2018.
Enzalutamide
Enzalutamide is an androgen receptor inhibitor. It was approved by the FDA for the treatment of patients with mCRPC in 2012, with warning and precautions added in 2017 regarding the risk of seizure and encephalopathy.
Cohort_2LH
Patients with mCRPC who received NAH monotherapy (Abiraterone or Enzalutamide) as 1L after diagnosis of mCRPC who then received another NAH monotherapy (i.e., Abiraterone to Enzalutamide or Enzalutamide to Abiraterone) as 2L treatment. None of the patients had ever received Radium-223 dichloride
Abiraterone
Abiraterone is a CYP17 inhibitor. It was approved by the FDA for the treatment of patients with mCRPC in 2011, and for patients with metastatic high-risk castration-sensitive prostate cancer in 2018.
Enzalutamide
Enzalutamide is an androgen receptor inhibitor. It was approved by the FDA for the treatment of patients with mCRPC in 2012, with warning and precautions added in 2017 regarding the risk of seizure and encephalopathy.
Interventions
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Radium-223 (Xofigo, BAY88-8223)
Ra-223 was approved by the FDA in May 2013 for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease.
Abiraterone
Abiraterone is a CYP17 inhibitor. It was approved by the FDA for the treatment of patients with mCRPC in 2011, and for patients with metastatic high-risk castration-sensitive prostate cancer in 2018.
Enzalutamide
Enzalutamide is an androgen receptor inhibitor. It was approved by the FDA for the treatment of patients with mCRPC in 2012, with warning and precautions added in 2017 regarding the risk of seizure and encephalopathy.
Eligibility Criteria
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Inclusion Criteria
* Initiation of Ra-223 after 1L NAH therapy, or
* Initiation of sequential NAH therapy after 1L NAH therapy
Exclusion Criteria
* Patients who received combined therapies in 1L or 2L
MALE
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Locations
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US Flatiron prostate cancer database
Whippany, New Jersey, United States
Countries
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References
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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.
Related Links
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Click here to find results for studies related to Bayer products.
Other Identifiers
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20526
Identifier Type: -
Identifier Source: org_study_id