Radiation Medication (Radium-223 Dichloride) Versus Radium-223 Dichloride Plus Radiation Enhancing Medication (M3814) Versus Radium-223 Dichloride Plus M3814 Plus Avelumab (a Type of Immunotherapy) for Advanced Prostate Cancer Not Responsive to Hormonal Therapy
Public ClinicalTrials.gov record NCT04071236. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase I and Randomized Phase II Trial of Radium-223 Dichloride, M3814, &Amp; Avelumab in Advanced Metastatic Castrate-Resistant Prostate Cancer (mCRPC)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This phase I/II trial studies the best dose of M3814 when given together with radium-223 dichloride or with radium-223 dichloride and avelumab and to see how well they work in treating patients with castrate-resistant prostate cancer that had spread to other places in the body (metastatic). M3814 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radioactive drugs, such as radium-223 dichloride, may carry radiation directly to tumor cells and not harm normal cells. Immunotherapy with monoclonal antibodies, such as avelumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. This study is being done to find out the better treatment between radium-223 dichloride alone, radium-223 dichloride in combination with M3814, or radium-223 dichloride in combination with both M3814 and avelumab, to lower the chance of prostate cancer growing or spreading in the bone, and if this approach is better or worse than the usual approach for advanced prostate cancer not responsive to hormonal therapy.
Study identification
- NCT ID
- NCT04071236
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 90 participants
Conditions and interventions
Conditions
Interventions
- Avelumab Drug
- Biospecimen Collection Procedure
- Bone Scan Procedure
- Computed Tomography Procedure
- Magnetic Resonance Imaging Procedure
- Peposertib Drug
- Questionnaire Administration Other
- Radium Ra 223 Dichloride Radiation
Drug · Procedure · Other + 1 more
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Male
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 14, 2020 (Actual)
- Primary completion
- Apr 30, 2027 (Estimated)
- Completion
- Apr 30, 2027 (Estimated)
- Last update posted
- Oct 7, 2026
2020 – 2027
United States locations
- U.S. sites
- 32
- U.S. states
- 14
- U.S. cities
- 27
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| City of Hope Comprehensive Cancer Center | Duarte | California | 91010 | — |
| Los Angeles General Medical Center | Los Angeles | California | 90033 | — |
| USC / Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | — |
| UC Irvine Health/Chao Family Comprehensive Cancer Center | Orange | California | 92868 | — |
| University of California Davis Comprehensive Cancer Center | Sacramento | California | 95817 | — |
| UM Sylvester Comprehensive Cancer Center at Aventura | Aventura | Florida | 33180 | — |
| UM Sylvester Comprehensive Cancer Center at Coral Gables | Coral Gables | Florida | 33146 | — |
| UM Sylvester Comprehensive Cancer Center at Deerfield Beach | Deerfield Beach | Florida | 33442 | — |
| University of Miami Miller School of Medicine-Sylvester Cancer Center | Miami | Florida | 33136 | — |
| UM Sylvester Comprehensive Cancer Center at Kendall | Miami | Florida | 33176 | — |
| UM Sylvester Comprehensive Cancer Center at Plantation | Plantation | Florida | 33324 | — |
| Emory University Hospital Midtown | Atlanta | Georgia | 30308 | — |
| Emory University Hospital/Winship Cancer Institute | Atlanta | Georgia | 30322 | — |
| Emory Saint Joseph's Hospital | Atlanta | Georgia | 30342 | — |
| University of Kansas Clinical Research Center | Fairway | Kansas | 66205 | — |
| University of Kansas Cancer Center | Kansas City | Kansas | 66160 | — |
| University of Kansas Cancer Center-Overland Park | Overland Park | Kansas | 66210 | — |
| University of Kansas Hospital-Westwood Cancer Center | Westwood | Kansas | 66205 | — |
| University of Kentucky/Markey Cancer Center | Lexington | Kentucky | 40536 | — |
| Wayne State University/Karmanos Cancer Institute | Detroit | Michigan | 48201 | — |
| Siteman Cancer Center at Saint Peters Hospital | City of Saint Peters | Missouri | 63376 | — |
| Siteman Cancer Center at West County Hospital | Creve Coeur | Missouri | 63141 | — |
| University of Kansas Cancer Center at North Kansas City Hospital | North Kansas City | Missouri | 64116 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| Siteman Cancer Center-South County | St Louis | Missouri | 63129 | — |
| Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center | Lebanon | New Hampshire | 03756 | — |
| Laura and Isaac Perlmutter Cancer Center at NYU Langone | New York | New York | 10016 | — |
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | — |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | — |
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | — |
| UT Southwestern/Simmons Cancer Center-Dallas | Dallas | Texas | 75390 | — |
| Huntsman Cancer Institute/University of Utah | Salt Lake City | Utah | 84112 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04071236, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 7, 2026 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04071236 live on ClinicalTrials.gov.