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).
NCT03896984, Completed, Bayer
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. 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). Trials, record NCT03896984. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03896984
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
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 number
- NCT03896984
- Status
- Completed
- Enrollment
- 346 participants, actual
- Lead sponsor
- Bayer
- Conditions
- Metastatic Castration-resistant Prostate Cancer (mCRPC)
- Interventions
- Radium-223 (Xofigo, BAY88-8223), Abiraterone, Enzalutamide
- First posted
- 2019-04-01
- Last updated
- 2021-12-29
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall survival (OS) from initiation of 2L therapy of Radium-223 in patients with mCRPC after 1L NAH therapy | Retrospective analysis from 2013-01-01 to 2018-12-30 | |
| Primary | Overall survival (OS) from initiation of 2L therapy of sequential NAH in patients with mCRPC after 1L NAH therapy | Retrospective analysis from 2013-01-01 to 2018-12-30 | |
| Secondary | Descriptive analysis of patient demography at baseline | Retrospective analysis from 2013-01-01 to 2018-12-30 | Demographic characteristics includes: * Gender (expecting 100% male) * Age (in the year of index date) * Ethnicity |
| Secondary | Descriptive analysis of clinical characteristics of patients at baseline | Retrospective analysis from 2013-01-01 to 2018-12-30 | Clinical characteristics includes: * Histology * Gleason score * Clinical stage (at initial diagnosis) * T/N/M stage (at initial diagnosis) * ECOG performance status * Site of metastasis (visceral, lymph node, bone) |
| Secondary | Descriptive analysis of laboratory values at baseline | Retrospective analysis from 2013-01-01 to 2018-12-30 | The laboratory tests of interest includes: * Prostate Specific Antigen(PSA) * Alkaline Phosphatase(ALP) * Hemoglobin (Hgb) * Lactate dehydrogenase (LDH) |
| Secondary | Frequency of SSEs of Radium-223 versus Abiraterone or Enzalutamide after 2L | Retrospective analysis from 2013-01-01 to 2018-12-30 | SSE:Symptomatic skeletal event |
| Secondary | Incidence rate of SSEs of Radium-223 versus Abiraterone or Enzalutamide after 2L | Retrospective analysis from 2013-01-01 to 2018-12-30 | |
| Secondary | Frequency of pathologic fracture of Radium-223 versus Abiraterone or Enzalutamide after 2L | Retrospective analysis from 2013-01-01 to 2018-12-30 | |
| Secondary | Incidence rate of pathologic fracture of Radium-223 versus Abiraterone or Enzalutamide after 2L | Retrospective analysis from 2013-01-01 to 2018-12-30 | |
| Secondary | Period of time from initiation of 2L to first SSE | Retrospective analysis from 2013-01-01 to 2018-12-30 |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34636627 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03896984
GET https://conductscience.org/api/trials/v1/NCT03896984/registered