Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Castration-resistant Prostate Cancer (mCRPC) | Castration-Resistant Prostate Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Abiraterone | Drug | Abiraterone | ALIAS |
| Enzalutamide | Drug | Enzalutamide | ALIAS |
| Radium-223 (Xofigo, BAY88-8223) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Cohort_2LX
- description
- 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
- interventionNames
- Drug: Radium-223 (Xofigo, BAY88-8223)
- Drug: Abiraterone
- Drug: Enzalutamide
- label
- Cohort_2LH
- description
- 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
- interventionNames
- Drug: Abiraterone
- Drug: Enzalutamide
Primary outcomes (2)
- measure
- Overall survival (OS) from initiation of 2L therapy of Radium-223 in patients with mCRPC after 1L NAH therapy
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
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
References
Publications (1)
- RESULTSartor 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. PMID 34636627