Prostate CancerNCT02135484
Radium 223 in Castrate Resistant Prostate Cancer Bone Metastases
A study testing Alpharadin in people with Prostate Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to learn more about how the study drug alpharadin (Radium-223) works in patients who have CPRC that has spread to the bone. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Alpharadin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Sep 2014to 11 Nov 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically proven adenocarcinoma of the prostate with evidence for skeletal metastases on bone scan and/or CT scan and symptoms judged to be related to bone metastases
- Eastern Cooperative Oncology Group (ECOG) performance status < 2. (Karnofsky Performance Status >/= 50%)
- Serum testosterone levels < 50ng/ml
- Ongoing gonadal androgen deprivation therapy with Luteinizing Hormone-Releasing Hormone (LHRH) analogues or orchiectomy. Patients, who have not had an orchiectomy, must be maintained on standard dosing of LHRH analogue therapy at appropriate frequency for the duration of the study
- Life expectancy of at least 12 weeks (3 months)
- Discontinue any steroids prescribed to specifically treat prostate cancer (for e.g as a secondary hormonal manipulation or for cord compression) > 4 weeks prior to study drug. Steroids chronically prescribed for a non-cancer-related illness [e.g. asthma or chronic obstructive pulmonary disease (COPD)] that is well controlled with medical management are permissible to an equivalent of <10 mg Prednisone daily. Note: Steroids may be administered during the study as supportive care
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- Laboratory Requirements: a.) white blood cell (WBC) count > 3,000/ul; b.) Absolute Neutrophil Count (ANC) > 1,500/ul; c.) Hemoglobin >/= 8.0 g/dL independent of transfusion; d.) Platelet count >/= 100,000/uL; e.) Serum albumin >/= 3.0 g/dL; f.) Calculated or measured creatinine clearance > 30 mL/min
- All acute toxic effects of any prior treatment have resolved to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v4.0 Grade 1 or less at the time of signing the Informed Consent Form (ICF)
- Patient must be willing and able to comply with protocol requirements. All patients must sign an informed consent indicating that they are aware of the investigational nature of this study
- Patients must also have signed an authorization for the release of their protected health information
Who cannot join
- Treatment with cytotoxic chemotherapy within previous 4 weeks of protocol treatment, or failure to recover from AEs due to cytotoxic chemotherapy administered more than 4 weeks prior to protocol treatment (however, ongoing neuropathy is permitted)
- Received systemic therapy with radionuclides (e.g., strontium-89, samarium-153, rhenium-186, or rhenium-188, or Ra-223 dichloride) for the treatment of bony metastases
- Other malignancy treated within the last 3 years (except non melanoma skin cancer or low-grade superficial bladder cancer)
- Visceral metastases as assessed by abdominal or pelvic computed tomography (CT) (or other imaging modality)
- Known brain metastases
- Lymphadenopathy exceeding 6 cm in short-axis diameter
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- Any size pelvic lymphadenopathy if it is thought to be a contributor to concurrent hydronephrosis
- Imminent spinal cord compression based on clinical findings and/or magnetic resonance imaging (MRI). Treatment should be completed for spinal cord compression
- Any other serious illness or medical condition, such as but not limited to: a) Any infection >/= National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0 Grade 2; b) Cardiac failure New York Heart Association (NYHA) III or IV; c) Crohn's disease or ulcerative colitis; d) Bone marrow dysplasia; e) Fecal incontinence
- Inability to comply with the protocol and/or not willing or not available for follow-up assessments
- Any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation
- Concurrent anti-cancer therapy (chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, or tumor embolization) other than Ra 223 dichloride
- Prior use of Ra-223 dichloride, Strontium or Samarium
- Concurrent use of another investigational drug or device therapy (i.e., outside of study treatment) during, or within 4 weeks of trial entry (signing of the informed consent form)
- Major surgery within 30 days prior to start of study drug
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: An Observation, Open Label Study of Alpharadin (Radium 223) in Patients With Castrate Resistant Prostate Cancer Bone Metastases
The goal of this clinical research study is to learn more about how the study drug alpharadin (Radium-223) works in patients who have CPRC that has spread to the bone.
Read the detailed description
Study Drug Administration:
If you are found to be eligible to take part in this study, you will receive radium-223 by vein over about 1 minute at the beginning of every study cycle for 6 cycles. Every 4 weeks is a study cycle.
You will need to be well hydrated before each dose by drinking at least 2-3 cups (8 ounces each) of water.
Do not take additional drugs, including over-the-counter products and herbal/alternative drugs, during the study without talking with the study doctor first.
Study Visits:
You will have a study visit before each dose of radium-223. The following tests and procedures will be performed:
- You will have a physical exam.
- Blood (about 3-4 tablespoons) will be drawn for routine and biomarker tests, as well as to check your PSA and testosterone levels.
- Urine will be collected for biomarker testing.
At Week 12, you will have bone marrow biopsy and aspiration performed to check the status of the disease and for biomarker testing.
At Week 24 the following tests and procedures will be performed:
- You will have a physical exam.
- Blood (about 3-4 tablespoons) will be drawn for routine tests, as well as to check your PSA and testosterone levels.
Length of Study:
You may receive the study drug for up to 6 doses. You will be taken off study early if the disease gets worse, if you have intolerable side effects, if your study doctor thinks it is in your best interest to stop, or if you are unable to follow study directions.
End of Treatment Visit:
After you stop receiving the study drug for any reason, the following tests and procedures will be performed:
- You will have a physical exam.
- You will have a sodium fluoride PET/CT scan to check the status of the disease.
- Blood (about 3-4 tablespoons) will be drawn for routine and biomarker tests, as well as to check your PSA and testosterone levels.
- Urine will be collected for biomarker testing.
- You will have a bone marrow aspiration and biopsy performed for biomarker testing.
Long-Term Follow-Up:
The study staff will check up on you about every 6 months after your last dose of study drug. This will consist of a phone call, an e-mail, or a review of your medical records. If you are contacted by phone, the call will last about 5 minutes.
This is an investigational study. Radium-223 is FDA approved and commercially available for the treatment of metastatic CRPC that has spread to the bones but not to other organs. It is investigational to look for biomarkers that may be related to CRPC in patients who are receiving radium-223.
The study doctor can explain how the study drug is designed to work.
Up to 25 participants will be enrolled in this study. All will take part at MD Anderson.
- Conditions
- Prostate Cancer
- Being tested
- Alpharadin
- Keywords
- Prostate Cancer, Adenocarcinoma of the prostate, Castrate resistant prostate cancer, CRPC, Skeletal metastases, Alpharadin, Xofigo, Radium-223 chloride, Radium-223 dichloride
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlpharadinDrug
Also called Xofigo, Radium-223 chloride, Radium-223 dichloride
50 kBq (0.0014 mCi)/kg body weight, administered by slow intravenous injection over 1 minute every 4 weeks for 6 cycles (6 doses total).
| Study group | Role | What they receive |
|---|---|---|
| Alpharadin | Experimental | Participants treated with standard dosing of Alpharadin 50 kBq (0.0014 mCi)/kg body weight, administered by slow intravenous injection over 1 minute every 4 weeks for 6 cycles (6 doses total). Receives: Drug: Alpharadin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (Favorable and Unfavorable )
Overall survival is measured in months from the time of enrollment until death. Participants who survived longer then the median survival rate of 24.3 months were assigned favorable survival. Participants who survived less than 24.3 months were assigned unfavorable survival.
Measured: 3.6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2014 (estimated)
- Study start19 Sep 2014
- Primary completion11 Nov 2020
- Study completion11 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer, Prostate Cancer Foundation
- Responsible party
- Sponsor
- Investigators
- John Araujo, MD,PHD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02135484
- Sponsor's protocol ID
- 2013-0933
- Other IDs
- NCI-2014-02016
- Status last verified
- Feb 2022
- First submitted
- 8 May 2014
- Last updated
- 17 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Corn PG, Yu G, Fan Y, Zhang M, Troncoso P, Surasi DS, Liu S, Ajani JA, Logothetis CJ, Wang G, Panaretakis T, Lin SH. Spatial immune profiling of bone-metastatic castration-resistant prostate cancer reveals radium-223 immunomodulates the bone-tumor microenvironment. Prostate Cancer Prostatic Dis. 2026 Sep;29(3):602-610. doi: 10.1038/s41391-025-01069-1. Epub 2025 Dec 26.
PubMed 41454189
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observation, Open Label Study of Alpharadin (Radium 223) in Patients With Castrate Resistant Prostate Cancer Bone Metastases
- ClinicalTrials.gov ID
- NCT02135484
- Acronym / sponsor ID
- 2013-0933
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, Adenocarcinoma of the prostate, Castrate resistant prostate cancer, CRPC, Skeletal metastases, Alpharadin, Xofigo, Radium-223 chloride
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Bayer, Prostate Cancer Foundation
- Study start
- 19 Sep 2014 (actual)
- Primary completion
- 11 Nov 2020 (actual)
- Study completion
- 11 Nov 2020 (actual)
- First posted
- 12 May 2014 (estimated)
- Results
- Posted 17 Feb 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical research study is to learn more about how the study drug alpharadin (Radium-223) works in patients who have CPRC that has spread to the bone.
Detailed description
Study Drug Administration:
If you are found to be eligible to take part in this study, you will receive radium-223 by vein over about 1 minute at the beginning of every study cycle for 6 cycles. Every 4 weeks is a study cycle.
You will need to be well hydrated before each dose by drinking at least 2-3 cups (8 ounces each) of water.
Do not take additional drugs, including over-the-counter products and herbal/alternative drugs, during the study without talking with the study doctor first.
Study Visits:
You will have a study visit before each dose of radium-223. The following tests and procedures will be performed:
- You will have a physical exam.
- Blood (about 3-4 tablespoons) will be drawn for routine and biomarker tests, as well as to check your PSA and testosterone levels.
- Urine will be collected for biomarker testing.
At Week 12, you will have bone marrow biopsy and aspiration performed to check the status of the disease and for biomarker testing.
At Week 24 the following tests and procedures will be performed:
- You will have a physical exam.
- Blood (about 3-4 tablespoons) will be drawn for routine tests, as well as to check your PSA and testosterone levels.
Length of Study:
You may receive the study drug for up to 6 doses. You will be taken off study early if the disease gets worse, if you have intolerable side effects, if your study doctor thinks it is in your best interest to stop, or if you are unable to follow study directions.
End of Treatment Visit:
After you stop receiving the study drug for any reason, the following tests and procedures will be performed:
- You will have a physical exam.
- You will have a sodium fluoride PET/CT scan to check the status of the disease.
- Blood (about 3-4 tablespoons) will be drawn for routine and biomarker tests, as well as to check your PSA and testosterone levels.
- Urine will be collected for biomarker testing.
- You will have a bone marrow aspiration and biopsy performed for biomarker testing.
Long-Term Follow-Up:
The study staff will check up on you about every 6 months after your last dose of study drug. This will consist of a phone call, an e-mail, or a review of your medical records. If you are contacted by phone, the call will last about 5 minutes.
This is an investigational study. Radium-223 is FDA approved and commercially available for the treatment of metastatic CRPC that has spread to the bones but not to other organs. It is investigational to look for biomarkers that may be related to CRPC in patients who are receiving radium-223.
The study doctor can explain how the study drug is designed to work.
Up to 25 participants will be enrolled in this study. All will take part at MD Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Alpharadin | Experimental | Drug: AlpharadinParticipants treated with standard dosing of Alpharadin 50 kBq (0.0014 mCi)/kg body weight, administered by slow intravenous injection over 1 minute every 4 weeks for 6 cycles (6 doses total). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histologically proven adenocarcinoma of the prostate with evidence for skeletal metastases on bone scan and/or CT scan and symptoms judged to be related to bone metastases
- Eastern Cooperative Oncology Group (ECOG) performance status < 2. (Karnofsky Performance Status >/= 50%)
- Serum testosterone levels < 50ng/ml
- Ongoing gonadal androgen deprivation therapy with Luteinizing Hormone-Releasing Hormone (LHRH) analogues or orchiectomy. Patients, who have not had an orchiectomy, must be maintained on standard dosing of LHRH analogue therapy at appropriate frequency for the duration of the study
- Life expectancy of at least 12 weeks (3 months)
Key exclusion criteria (15 listed)
- Treatment with cytotoxic chemotherapy within previous 4 weeks of protocol treatment, or failure to recover from AEs due to cytotoxic chemotherapy administered more than 4 weeks prior to protocol treatment (however, ongoing neuropathy is permitted)
- Received systemic therapy with radionuclides (e.g., strontium-89, samarium-153, rhenium-186, or rhenium-188, or Ra-223 dichloride) for the treatment of bony metastases
- Other malignancy treated within the last 3 years (except non melanoma skin cancer or low-grade superficial bladder cancer)
- Visceral metastases as assessed by abdominal or pelvic computed tomography (CT) (or other imaging modality)
- Known brain metastases
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 |
|---|---|---|
| AlpharadinAlso: Xofigo, Radium-223 chloride, Radium-223 dichloride50 kBq (0.0014 mCi)/kg body weight, administered by slow intravenous injection over 1 minute every 4 weeks for 6 cycles (6 doses total). | Drug | Alpharadin |
Primary outcome
Overall Survival (Favorable and Unfavorable )
Time frame: 3.6 years
Overall survival is measured in months from the time of enrollment until death. Participants who survived longer then the median survival rate of 24.3 months were assigned favorable survival. Participants who survived less than 24.3 months were assigned unfavorable survival.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41454189Corn PG, Yu G, Fan Y, Zhang M, Troncoso P, Surasi DS, Liu S, Ajani JA, Logothetis CJ, Wang G, Panaretakis T, Lin SH. Spatial immune profiling of bone-metastatic castration-resistant prostate cancer reveals radium-223 immunomodulates the bone-tumor microenvironment. Prostate Cancer Prostatic Dis. 2026 Sep;29(3):602-610. doi: 10.1038/s41391-025-01069-1. Epub 2025 Dec 26.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
John Araujo, MD,PHD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alpharadin in people with Prostate Cancer, run by M.D. Anderson Cancer Center 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 10 inclusion and 15 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: finished, as of the sponsor's last update on 17 Feb 2022. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Overall Survival (Favorable and Unfavorable ) (time frame: 3.6 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02135484, which also lists 1 linked publication.
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 17 Feb 2022.