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NCT04206319 · ClinicalTrials.gov registry record · Phase 2
Radium-223 in Biochemically Recurrent Prostate Cancer
A Phase 2 study of Biochemical Recurrent Prostate Cancer, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 2
- Development phase
- 19
- Enrollment target
- 1
- Study location
NCT04206319: Active Phase 2 study of Biochemical Recurrent Prostate Cancer, sponsored by National Cancer Institute (NCI).
NCT04206319 is a Phase 2 study of Biochemical Recurrent Prostate Cancer that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 19 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04206319, a Phase 2 study of Biochemical Recurrent Prostate Cancer, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 19 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: Some men who have been treated for localized prostate cancer with surgery or radiation still show signs of the disease in their blood. This is called biochemically recurrent prostate cancer. Radium-223 is a small molecule. It uses radiation to kill cancer cells and improves survival in advanced prostate cancer. Researchers want to see if it can treat prostate cancer and induced immune changes earlier in the disease when the cancer is only detectable by prostate specific antigen (PSA) in the blood. Objective: To learn how Radium-223 affects men with rising PSA but no evidence of cancer on conventional CT or bone scan, but positive findings on PET or molecular imaging in the bones. The primary focus is impact on the immune system with secondary focus on impact on PSA and imaging. Eligibility: Men ages 18 and older with prostate cancer who have had surgery and/or radiation, but their PSA is rising even though no disease is visible on routine imaging scans (CT or bone scans). Patients are required to have PET or molecular imaging findings in bones, but not organs (lymph nodes are allowed). Design: Participants will be screened with a medical history and physical exam. Their ability to do normal tasks will be reviewed. They will give tissue samples or a report from their doctor about their cancer. They will have blood and urine tests. They will have an electrocardiogram to measure heart function. They will have a scan of their chest and abdomen using radiation or magnetic resonance imaging. They will have a bone scan with injection of Tc99. They will have a positron emission tomography scan with intravenous (IV) injection of 18F-NaF. Participants will get Radium-223 by IV. For this, a small plastic tube is put into an arm vein. Radium-223 will be given on Day 1 of each cycle (1 cycle = 4 weeks) for up to 6 cycles. Participants will repeat the screening tests during the study. They will also complete Quality of Life Surveys and give stool samples. Aft
Primary Outcome
to determine the statistically significant changes in immune cell populations compared to baseline in participants with biochemically recurrent prostate cancer
Conditions Studied
Interventions
- DRUG Radium-223
- DRUG 18F Sodium Fluoride
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2020-09-22 |
| Est. Completion | 2026-07-31 |
| Phase | Phase 2 |
What the registry record for NCT04206319 still lists
NCT04206319 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower).
The record links to 1 condition, with Biochemical Recurrent Prostate Cancer appearing as the primary indexed condition, and to 2 interventions - of which Radium-223 is the first listed.
NCT04206319 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT04206319 about?
NCT04206319 is a clinical study titled "Radium-223 in Biochemically Recurrent Prostate Cancer". Background: Some men who have been treated for localized prostate cancer with surgery or radiation still show signs of the disease in their blood. This is called biochemically recurrent prostate cancer. Radium-223 is a small molecule. It uses radiation to kill cancer cells and improves survival in ...
What is the current status of trial NCT04206319?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 19 participants. The study started on 2020-09-22. Estimated completion is 2026-07-31.
What conditions does trial NCT04206319 study?
This clinical trial studies the following conditions: Biochemical Recurrent Prostate Cancer.
What interventions are being tested in trial NCT04206319?
The interventions under investigation include: Radium-223 (DRUG), 18F Sodium Fluoride (DRUG).
Who is sponsoring clinical trial NCT04206319?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04206319 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04206319's enrollment target sits among peer trials
19 1894th of 2000 higher than 103 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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