Trials / Completed
CompletedNCT03896984
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).
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
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 346 (actual)
- Sponsor
- Bayer · Industry
- Sex
- Male
- Age
- —
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 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. |
| DRUG | 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. |
| DRUG | 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. |
Timeline
- Start date
- 2019-03-18
- Primary completion
- 2020-06-08
- Completion
- 2020-12-14
- First posted
- 2019-04-01
- Last updated
- 2021-12-29
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT03896984. Inclusion in this directory is not an endorsement.