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NCT04071236 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Stage IVB Prostate Cancer AJCC v8 and Metastatic Malignant Neoplasm in the Bone, sponsored by National Cancer Institute (NCI).

Recruiting
Registry status
Phase 1
Development phase
90
Enrollment target
20
Study locations

NCT04071236 is a Phase 1 study of Stage IVB Prostate Cancer AJCC v8 and Metastatic Malignant Neoplasm in the Bone that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 90 participants, below the 175-participant average among 45 other Stage IVB Prostate Cancer AJCC v8 trials with a reported enrollment target (49% lower). The trial reports 20 study locations across 6 states.

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The verdict

NCT04071236, a Phase 1 study of Stage IVB Prostate Cancer AJCC v8 and Metastatic Malignant Neoplasm in the Bone, is actively recruiting participants, sponsored by National Cancer Institute (NCI).

RECRUITING
Registry status
Phase 1
Development phase
90 participants
Enrollment target
20
Study locations

Study Summary

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.

Conditions Studied

Stage IVB Prostate Cancer AJCC v8 Metastatic Malignant Neoplasm in the Bone Metastatic Castration-resistant Prostate Carcinoma Metastatic Malignant Neoplasm in the Lymph Nodes

Interventions

  • PROCEDURE Biospecimen Collection
  • PROCEDURE Computed Tomography
  • PROCEDURE Magnetic Resonance Imaging
  • PROCEDURE Bone Scan
  • DRUG Avelumab

Study Locations (20)

Florida

  • UM Sylvester Comprehensive Cancer Center at Aventura - Aventura
  • UM Sylvester Comprehensive Cancer Center at Coral Gables - Coral Gables
  • UM Sylvester Comprehensive Cancer Center at Deerfield Beach - Deerfield Beach
  • University of Miami Miller School of Medicine-Sylvester Cancer Center - Miami
  • UM Sylvester Comprehensive Cancer Center at Kendall - Miami
  • UM Sylvester Comprehensive Cancer Center at Plantation - Plantation

California

  • City of Hope Comprehensive Cancer Center - Duarte
  • Los Angeles General Medical Center - Los Angeles
  • USC / Norris Comprehensive Cancer Center - Los Angeles
  • UC Irvine Health/Chao Family Comprehensive Cancer Center - Orange
  • University of California Davis Comprehensive Cancer Center - Sacramento

Kansas

  • University of Kansas Clinical Research Center - Fairway
  • University of Kansas Cancer Center - Kansas City
  • University of Kansas Cancer Center-Overland Park - Overland Park
  • University of Kansas Hospital-Westwood Cancer Center - Westwood

Georgia

  • Emory University Hospital Midtown - Atlanta
  • Emory University Hospital/Winship Cancer Institute - Atlanta
  • Emory Saint Joseph's Hospital - Atlanta

Kentucky

  • University of Kentucky/Markey Cancer Center - Lexington

Michigan

  • Wayne State University/Karmanos Cancer Institute - Detroit

Trial Details

FieldValue
Enrollment Target 90 participants
Start Date 2020-10-14
Est. Completion 2026-04-30
Phase Phase 1

Sponsor

National Cancer Institute (NCI)

3,257 total trials

Interested in This Trial?

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04071236

The ClinicalTrials.gov registry entry for NCT04071236 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 90 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 175-participant average among 45 other Stage IVB Prostate Cancer AJCC v8 trials with a reported enrollment target (49% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.

The record links to 4 conditions, with Stage IVB Prostate Cancer AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.

NCT04071236 reports 20 study locations spanning 6 distinct geographic areas - top geographies include Florida, California, Kansas.

Frequently Asked Questions

What is clinical trial NCT04071236 about?

NCT04071236 is a clinical study titled "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". 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 ma...

What is the current status of trial NCT04071236?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 90 participants. The study started on 2020-10-14. Estimated completion is 2026-04-30.

What conditions does trial NCT04071236 study?

This clinical trial studies the following conditions: Stage IVB Prostate Cancer AJCC v8, Metastatic Malignant Neoplasm in the Bone, Metastatic Castration-resistant Prostate Carcinoma, Metastatic Malignant Neoplasm in the Lymph Nodes.

What interventions are being tested in trial NCT04071236?

The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Bone Scan (PROCEDURE), Avelumab (DRUG).

Who is sponsoring clinical trial NCT04071236?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04071236 being conducted?

This trial has 20 study locations across California, Florida, Georgia, Kansas, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.