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Prostate CancerPhase 2NCT02225704

Radium-223 in Combination With Enzalutamide

A Phase 2 study testing Radium-223 and enzalutamide in people with Prostate Cancer, run by Cancer Trials Ireland at 7 sites in Ireland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study aims to determine the safety and tolerability of Radium-223 when administered in combination with enzalutamide in progressive metastatic castrate-resistant prostate cancer. 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?
Radium-223 and enzalutamide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
7 sitesIreland
Study dates
3 Jun 2015to 23 Nov 2021
Phase
Phase 2
Are there results?
None posted in the registry

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

  • Written informed consent obtained prior to any study-related procedures
  • Age ≥18 years and male.
  • ECOG performance status ≤ 2.
  • Histologically/cytologically confirmed adenocarcinoma of the prostate, and without neuroendocrine differentiation or small cell histology.
  • Metastatic disease as confirmed by Computed tomography (CT)/ Magnetic resonance imaging (MRI) or bone scan.
  • 6. Patients must have documented Progressive disease (PD) either by radiographic or PSA criteria as defined in a) and b) below:
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  • For the Radiographic PD assessment, 2 sets of scans using the same imaging modality (ie CT/MRI or bone scan) and taken at separate time points are required to document radiographic disease progression during or following the patient's most recent anti-neoplastic therapy, (note: the 1st bone scan can be from before most recent therapy but the 2nd scan must show disease progression during or after the most recent therapy).
  • For patients with bone disease, progression will be assessed following recommendations by the Prostate Cancer Working Group (PCWG2, see Appendix FC): appearance of 2 or more new lesions on bone scan, confirmed, if necessary, by other imaging modalities (such as CT scan or MRI), if results of the bone scans are ambiguous).
  • For patients with soft tissue lesions progression will be assessed using RECIST 1.1 criteria, (see Appendix GD). Patients may have measurable or non-measurable disease according to RECIST criteria version 1.1 (see Appendix GD)
  • PSA progression is defined as an increase in PSA, as determined by 2 separate measurements taken at least 1 week apart and confirmed by a third. If the third measurement is not greater than the second measurement, then a fourth measurement must be taken and must be greater than the second measurement for the patient to be eligible for the study. Furthermore, the confirmatory PSA measurement (i.e. the third or, if applicable, fourth PSA measurement) must be defined. If a patient has received prior anti-androgen therapy (e.g. bicalutamide), PSA progression must be evident and documented after discontinuation of anti-androgen therapy, (note: The 1st PSA reading taken to document disease progression when the patient presents can be while the patient is on Casodex or other ADT).
  • Prior surgical castration or concurrent use of an agent for medical castration with testosterone at screening less than 50ng/dL.
  • Screening PSA ≥ 2 ng/mL.
  • Patients, even if surgically sterilized who (i.e. status post-vasectomy):
  • will abstain from intercourse
  • or must agree to use barrier contraception during and for 6 months after discontinuation of study treatment.
  • If the patient engages in sexual intercourse with a woman of childbearing potential, a condom and another form of birth control must be used during and for 6 months after treatment.
  • Stable medical condition
  • Life expectancy of 12 months or more based on general health and prostate cancer disease status as judged by the investigator.
  • Documented presence of osseous metastases with or without visceral involvement / lymph nodes.
  • Able to swallow study drug as whole tablet.
  • Adequate haematological, hepatic, and renal function.
  • Continuous daily use of oral prednisone, oral dexamethasone, or other systemic corticosteroids is allowed prior to study entry but must be discontinued a minimum of 2 weeks prior to start of study treatment.

Who cannot join

  • Patients should not be receiving any other investigational agents (within 30 days prior to registration)
  • Patients with Gastrointestinal (GI) tract disease resulting in an inability to take oral medication, malabsorption syndrome, a requirement for IV alimentation, prior surgical procedures affecting absorption, uncontrolled inflammatory GI disease (e.g. Crohn's disease, ulcerative colitis).
  • Have current active hepatic or biliary disease
  • Prior therapy with orteronel, ketoconazole, aminoglutethimide, abiraterone or enzalutamide
  • All anti-androgen therapy (including bicalutamide) is excluded within 6 weeks prior to first dose of study drug. Any other therapies for prostate cancer, other than GnRH analogue therapy, such as progesterone, medroxyprogesterone, progestins (megesterol), or 5-alpha reductase inhibitors (eg, finasteride or dutasteride), must be discontinued 2 weeks before the first dose of study drug. [Bisphosphonates and Denosumab are allowed concomitant medications].
  • Prior chemotherapy for prostate cancer with the exception of:
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  • neoadjuvant/ adjuvant therapy as part of initial primary treatment for local disease that was completed 2 or more years prior to screening.
  • Patients who received prior docetaxol for castrate sensitive metastatic prostate cancer commencing with 120 days of ADT initation where total dose received did not exceed 450mg/m2
  • Prior exposure to bone directed radioisotope therapy, eg samarium 153, strontium 90;
  • Exposure to external beam radiation within 4 weeks prior to receiving the first dose of study drug. In patients with untreated imminent or established spinal cord compression, treatment with standard of care, as clinically indicated, should be completed before starting treatment with Ra-223 dichloride (Xofigo®).
  • Diagnosis of or treatment for another systemic malignancy within 2 years before the first dose of study drug, or previously diagnosed with another malignancy and have any evidence of residual disease.
  • History of myocardial infarction, unstable symptomatic ischemic heart disease/ unstable angina, uncontrolled on-going arrhythmias of Grade >2 , pulmonary embolism, or any other cardiac condition within 6 months prior to first dose of study drug.
  • New York Heart Association Class III or IV heart failure.
  • History of seizure, underlying brain injury with loss of consciousness, stroke, transient ischaemic attack (TIA), cerebral vascular accident, primary brain tumours or brain metastases, brain arteriovenous malformation, alcoholism., or the use of concomitant medications that may lower the seizure threshold.
  • Known human immunodeficiency virus (HIV) infection, active chronic hepatitis B or C, life-threatening illness unrelated to cancer, or any ongoing serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with participation in this study. Patients will be tested for hepatitis B or C or HIV infection during screening if they are considered by the investigator to be at higher risk for these infections and have not been previously tested, or if testing is required by the independent ethics committee or institutional review board.
  • Prohibited medications, including drugs that may affect exposure to enzalutamide i.e. study drugs that induce or inhibit CYP3A4, CYP2C8, and CYP2C9

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

Ireland7 sites

  • Cork University Hospital

    Cork

  • Mater Misericordiae University Hospital

    Dublin

  • Mater Private Hospital

    Dublin

  • SLRON, St James's Hospital

    Dublin

  • St Vincents University Hospital / AMNCH

    Dublin

  • Tallaght Hospital

    Dublin

  • Galway University Hospital

    Galway

Other trials in Ireland

About this study

Official title: A Phase II Study of Radium-223 in Combination With Enzalutamide in Progressive Metastatic Castrate-Resistant Prostate Cancer

This study aims to determine the safety and tolerability of Radium-223 when administered in combination with enzalutamide in progressive metastatic castrate-resistant prostate cancer.

Conditions
Prostate Cancer
Being tested
Radium-223 and enzalutamide
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Radium-223 and enzalutamideDrug

Study groups in NCT02225704
Study groupRoleWhat they receive
Radium-223 and enzalutamideExperimentalRadium-223 50kBq/kg by intravenous injection on day 1 of every 4 week cycle for maximum of 6 cycles Enzalutamide 160mg orally daily
Receives: Drug: Radium-223 and enzalutamide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To determine safety

    To record the incidence of grade 3 or higher adverse events during the period of combination therapy; graded according to the NCI CTCAE version 4

    Measured: approximately 6 to 9 months

Secondary outcomes (5)

  1. Time to clinical and Prostate Specific Antigen (PSA) progression

    Measured: Approximately 2 years

  2. PSA response

    Measured: approximately 2 years

  3. Time to first skeletal-related event

    Time to first skeletal-related event will be analysed using the Kaplan-Meier method, presenting estimated of median PFS with 95% confidence intervals, also estimates of PFS and 95% confidence intervals at 12 months

    Measured: approximately 2 years

  4. Pain assessment

    The Brief Pain Inventory - Short Form questionnaire will be used to gather this data

    Measured: approximately 6 - 9 months

  5. Measure overall survival

    Measured: approximately 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Aug 2014 (estimated)
  2. Study start3 Jun 2015
  3. Primary completionJul 2017
  4. Study completion23 Nov 2021

Resources

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
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02225704
Sponsor's protocol ID
CTRIAL (ICORG) 13-21
Status last verified
Apr 2026
First submitted
22 Aug 2014
Last updated
13 Apr 2026
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Radium-223 and enzalutamide in people with Prostate Cancer, run by Cancer Trials Ireland at 7 sites in Ireland.

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 16 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 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Ireland. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

To determine safety (time frame: approximately 6 to 9 months). 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 NCT02225704.

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 13 Apr 2026.

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