Biochemical Recurrent Prostate CancerPhase 2NCT04206319
Radium-223 in Biochemically Recurrent Prostate Cancer
A Phase 2 study testing Radium-223 and 18F Sodium Fluoride in people with Biochemical Recurrent Prostate Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 120 years, men only
- Conditions the study is for
- Biochemical Recurrent Prostate Cancer
- What is being tested?
- Radium-223 and 18F Sodium Fluoride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Sep 2020to 31 Jul 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histopathological confirmation of prostate adenocarcinoma confirmed in either the Laboratory of Pathology at the National Institutes of Health (NIH) Clinical Center, or Walter Reed National Military Medical Center prior to enrollment. If no pathologic specimen is available, participants may enroll with a pathologist s report showing a histologic diagnosis of prostate cancer and a clinical course consistent with the disease.
- Biochemical progression after definitive surgery or radiation define as follows:
- Participants must have a detectable PSA
- Negative CT scan/MRI and Tc99 bone scan for metastatic prostate cancer. (Only Tc99 will be used to detect bone lesions, CT/MRI would be used to detect soft tissue lesions)
- Presence of findings on PET scan (i.e., NaF PET scan) suspicious for metastatic prostate cancer in bone. Note: while lymph node findings would be allowed and provide the opportunity for the assessment of any abscopal effects, PET scan findings suggesting visceral disease will be excluded.
- Testosterone >= 100 ng/dL
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- ECOG performance status of 0 1
- Recovery from acute toxicity related to prior therapy, including surgery and radiation, (defined as no toxicity >= grade 2).
- Hematological eligibility parameters (within 16 days before treatment initiation):
- Granulocyte count >= 3,000/mm^3
- Absolute neutrophil count (ANC) >= 1,500/mm^3
- Platelet count >= 100,000/mm^3
- Hgb >= 10 g/dL
- Hepatic function eligibility parameters (within 16 days before treatment initiation)
- -- Bilirubin <=1.5 mg/dL (OR in participants with Gilbert s syndrome, a total bilirubin <= 3.0), AST and ALT <= 2.5 times upper limit of normal.
- Adequate renal function defined by eGFR within normal as predicted by the CKD-EPI equation (>= 50 mL/min/1.73m^2) or by measure o f creatinine clearance from 24-hour urine collection.
- No other active malignancies within 36 months of treatment initiation (with the exception of nonmelanoma skin cancers or carcinoma in situ of the bladder)
- Participants must be >=18 years old. Currently, no dosing or adverse event data is available on the use of radium in participants < 18 years of age; therefore, only adults are included in this study.
- Ability of subject to understand and the willingness to sign a written informed consent document.
- The effects radium-223 on the developing human fetus are unknown but based on the mechanism of action, radium-223 has the potential to cause fetal harm. For this reason, men must agree to use condoms for the duration of study therapy and at least 6 months
- after the last treatment administration. Female partners of reproductive potential must use a highly effective method of birth control during treatment and for 6 months after their partner s last treatment administration. Should a woman become pregnant or suspect she
- is pregnant while her partner is participating in this study, she should inform her treating physician immediately.
Who cannot join
- Participants with immunocompromised status due to Human Immunodeficiency Virus (HIV) infection or other immunodeficiency diseases because this is a trial with a primary endpoint looking at immune response, requiring functional immune systems.
- Participants who test positive for HBV or HCV.
- Chronic administration (defined as daily or every other day for continued use > 14 days) of systemic corticosteroids within 28 days of treatment initiation. Use of corticosteroids with minimal systemic absorption (e.g., inhaled steroids, nasal sprays, intraarticular, and topical agents) is allowed.
- Receipt of any organ transplantation, including allogeneic stem-cell transplantation, but with the exception of transplants that do not require immunosuppression (e.g. corneal transplant, hair transplant).
- Serious intercurrent medical illness that, in the judgement of the investigator, would interfere with participant's ability to carry out the treatment program.
- Subjects required other medications known to alter PSA including 5-alpha reductase inhibitors (finasteride and dutasteride) and alternative therapies (e.g., phytoestrogens and saw palmetto).
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- History of prior chemotherapy.
- History of prior systemic therapy with radionuclides (e.g., strontium-89, samarium-153, rhenium-186, rhenium-188, or radium 223 dichloride).
- Receipt of an investigational agent within 28 days (or 56 days for an antibody-based therapy) of treatment initiation.
- Major surgery within 28 days prior to treatment initiation.
- PET scan findings suggesting visceral disease.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: Phase II Trial of 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 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.
Read more
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.
After treatment, participants will have long-term follow-up every 6 weeks for the rest of their lives.
Read the detailed description
Background:
Androgen deprivation therapy (ADT) and surveillance are treatment options for prostate cancer patients with biochemical progression after localized therapy with either definitive radiation or surgery (biochemically recurrent prostate cancer). A primary goal in these patients is to prevent morbidity from their cancer that results from disease progression and metastatic disease on conventional imaging.
Radium-223 has demonstrated the ability to improve survival in men with symptomatic metastatic castration resistant prostate cancer (mCRPC) with a manageable toxicity profile, particularly in patients who have not yet received docetaxel.
Radiation, even at low doses can impact immune recognition and immune cell killing of cancer cells. Recent findings by the LTIB suggest that radium-223 potentiated T-cell killing of prostate cancer cells.
Radium-223 may present an alternative option for patients with BRPC that is not associated with substantial toxicity (as seen with ADT) and may have a lasting effect due to its potential effect on the immune system and/or the bone microenvironment.
Emerging PET imaging studies will likely find evidence of micrometastatic disease, often in the bones, in biochemically recurrent prostate cancer patients, although these patients will have no standard of care that can be supported by prospective data.
Radium-223 has demonstrated the ability to improve survival in men with symptomatic prostate cancer, but it remains unknown what the impact is in patients with micrometastatic or PET positive prostate cancer in their bones
Preclinical data has suggested that radium-223 can impact the immune system.
In addition, changes in PSA kinetics, changes on PET scan findings, and safety and tolerability of radium-223 in this population will also be evaluated.
Objective:
To determine statistically significant changes in immune cell populations compared to baseline in participants with biochemically recurrent or 18F NaF PET scan positive prostate cancer treated with radium-223
Eligibility:
Histologically confirmed adenocarcinoma of the prostate
Imaging showing positive findings on NaF PET, negative CT Scan and Tc-99m Bone Scan
Detectable PSA
ECOG 0-1
Design:
Single arm study
Participants will receive 6 injections of radium-223 with monthly assessments of PSA and periodic immune response. NaF PET scans will be completed at screening then at 4 and 7 months after the start of radium-223.
After completion of treatment participant will be followed every 6 (+/- 2 weeks).
- Conditions
- Biochemical Recurrent Prostate Cancer
- Being tested
- Radium-223, 18F Sodium Fluoride
- Keywords
- Immune Response, Isotope, PSA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radium-223Drug
an alpha particle-emitting drug, dose consists of 55 kBq/kg (1.49 microcurie/kg); administered every 4 days
18F Sodium FluorideDrug
18F-NaF (Sodium Fluoride) is a radio-pharmaceutical used to image skeletal pathology with positron emission tomography (PET) imaging
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Participants will receive radium-223 treatment every 4 weeks for up to 6 cycles. 18F-NaF PET scans will be used to assess response in bone. Receives: Drug: Radium-223; Drug: 18F Sodium Fluoride |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in immune cell populations
to determine the statistically significant changes in immune cell populations compared to baseline in participants with biochemically recurrent prostate cancer
Measured: 6 months
Secondary outcomes (3)
Changes in PSA kinetics
rate of change in PSA per month
Measured: 6 months
Changes in PSA kinetics and the changes in immune cell populations relative to patients with similar disease undergoing a surveillance period on a similar protocol (NCT02649439)
rate of change in PSA per month compared against those on the surveillance arm of 16-C-0035
Measured: 6 months
Safety and tolerability of radium-223
type, number and frequency of adverse events
Measured: every 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2019
- Study start22 Sep 2020
- Primary completion10 Feb 2026
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biochemical Recurrent Prostate CancerStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Melissa L Abel, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04206319
- Sponsor's protocol ID
- 200010
- Other IDs
- 20-C-0010
- Status last verified
- 10 Mar 2026
- First submitted
- 19 Dec 2019
- Last updated
- 16 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD recorded in the medical record will be shared with intramural investigators upon request. In addition, all large scale genomic sequencing data will be shared with subscribers to dbGaP. All collected IPD will be shared with collaborators under the terms of collaborative agreements.
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Radium-223 in Biochemically Recurrent Prostate Cancer
- ClinicalTrials.gov ID
- NCT04206319
- Acronym / sponsor ID
- 200010
- Conditions
- Biochemical Recurrent Prostate Cancer
- Keywords
- Immune Response, Isotope, PSA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 19 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 22 Sep 2020 (actual)
- Primary completion
- 10 Feb 2026 (actual)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 20 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
After treatment, participants will have long-term follow-up every 6 weeks for the rest of their lives.
Detailed description
Background:
Androgen deprivation therapy (ADT) and surveillance are treatment options for prostate cancer patients with biochemical progression after localized therapy with either definitive radiation or surgery (biochemically recurrent prostate cancer). A primary goal in these patients is to prevent morbidity from their cancer that results from disease progression and metastatic disease on conventional imaging.
Radium-223 has demonstrated the ability to improve survival in men with symptomatic metastatic castration resistant prostate cancer (mCRPC) with a manageable toxicity profile, particularly in patients who have not yet received docetaxel.
Radiation, even at low doses can impact immune recognition and immune cell killing of cancer cells. Recent findings by the LTIB suggest that radium-223 potentiated T-cell killing of prostate cancer cells.
Radium-223 may present an alternative option for patients with BRPC that is not associated with substantial toxicity (as seen with ADT) and may have a lasting effect due to its potential effect on the immune system and/or the bone microenvironment.
Emerging PET imaging studies will likely find evidence of micrometastatic disease, often in the bones, in biochemically recurrent prostate cancer patients, although these patients will have no standard of care that can be supported by prospective data.
Radium-223 has demonstrated the ability to improve survival in men with symptomatic prostate cancer, but it remains unknown what the impact is in patients with micrometastatic or PET positive prostate cancer in their bones
Preclinical data has suggested that radium-223 can impact the immune system.
In addition, changes in PSA kinetics, changes on PET scan findings, and safety and tolerability of radium-223 in this population will also be evaluated.
Objective:
To determine statistically significant changes in immune cell populations compared to baseline in participants with biochemically recurrent or 18F NaF PET scan positive prostate cancer treated with radium-223
Eligibility:
Histologically confirmed adenocarcinoma of the prostate
Imaging showing positive findings on NaF PET, negative CT Scan and Tc-99m Bone Scan
Detectable PSA
ECOG 0-1
Design:
Single arm study
Participants will receive 6 injections of radium-223 with monthly assessments of PSA and periodic immune response. NaF PET scans will be completed at screening then at 4 and 7 months after the start of radium-223.
After completion of treatment participant will be followed every 6 (+/- 2 weeks).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Radium-223, Drug: 18F Sodium FluorideParticipants will receive radium-223 treatment every 4 weeks for up to 6 cycles. 18F-NaF PET scans will be used to assess response in bone. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Histopathological confirmation of prostate adenocarcinoma confirmed in either the Laboratory of Pathology at the National Institutes of Health (NIH) Clinical Center, or Walter Reed National Military Medical Center prior to enrollment. If no pathologic specimen is available, participants may enroll with a pathologist s report showing a histologic diagnosis of prostate cancer and a clinical course consistent with the disease.
- Biochemical progression after definitive surgery or radiation define as follows:
- Participants must have a detectable PSA
- Negative CT scan/MRI and Tc99 bone scan for metastatic prostate cancer. (Only Tc99 will be used to detect bone lesions, CT/MRI would be used to detect soft tissue lesions)
- Presence of findings on PET scan (i.e., NaF PET scan) suspicious for metastatic prostate cancer in bone. Note: while lymph node findings would be allowed and provide the opportunity for the assessment of any abscopal effects, PET scan findings suggesting visceral disease will be excluded.
Key exclusion criteria (11 listed)
- Participants with immunocompromised status due to Human Immunodeficiency Virus (HIV) infection or other immunodeficiency diseases because this is a trial with a primary endpoint looking at immune response, requiring functional immune systems.
- Participants who test positive for HBV or HCV.
- Chronic administration (defined as daily or every other day for continued use > 14 days) of systemic corticosteroids within 28 days of treatment initiation. Use of corticosteroids with minimal systemic absorption (e.g., inhaled steroids, nasal sprays, intraarticular, and topical agents) is allowed.
- Receipt of any organ transplantation, including allogeneic stem-cell transplantation, but with the exception of transplants that do not require immunosuppression (e.g. corneal transplant, hair transplant).
- Serious intercurrent medical illness that, in the judgement of the investigator, would interfere with participant's ability to carry out the treatment program.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radium-223an alpha particle-emitting drug, dose consists of 55 kBq/kg (1.49 microcurie/kg); administered every 4 days | Drug | 1 |
| 18F Sodium Fluoride18F-NaF (Sodium Fluoride) is a radio-pharmaceutical used to image skeletal pathology with positron emission tomography (PET) imaging | Drug | 1 |
Primary outcome
changes in immune cell populations
Time frame: 6 months
to determine the statistically significant changes in immune cell populations compared to baseline in participants with biochemically recurrent prostate cancer
3 secondary outcomes
Changes in PSA kinetics
Time frame: 6 months
Changes in PSA kinetics and the changes in immune cell populations relative to patients with similar disease undergoing a surveillance period on a similar protocol (NCT02649439)
Time frame: 6 months
Safety and tolerability of radium-223
Time frame: every 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All IPD recorded in the medical record will be shared with intramural investigators upon request. In addition, all large scale genomic sequencing data will be shared with subscribers to dbGaP. All collected IPD will be shared with collaborators under the terms of collaborative agreements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melissa L Abel, M.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Radium-223 and 18F Sodium Fluoride in people with Biochemical Recurrent Prostate Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in immune cell populations (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.