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COMPLETEDPHASE2

Radium-223 in Combination With Enzalutamide

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

NCT02225704•Cancer Trials Ireland

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•1. Written informed consent obtained prior to any study-related procedures
•2. Age ≥18 years and male.
•3. ECOG performance status ≤ 2.
•4. Histologically/cytologically confirmed adenocarcinoma of the prostate, and without neuroendocrine differentiation or small cell histology.
•5. Metastatic disease as confirmed by Computed tomography (CT)/ Magnetic resonance imaging (MRI) or bone scan.
•6. 6\. Patients must have documented Progressive disease (PD) either by radiographic or PSA criteria as defined in a) and b) below:
•1. 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)
•2. 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).
+12 more criteria

Exclusion Criteria

•1. Patients should not be receiving any other investigational agents (within 30 days prior to registration)
•2. 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).
•3. Have current active hepatic or biliary disease
•4. Prior therapy with orteronel, ketoconazole, aminoglutethimide, abiraterone or enzalutamide
•5. 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. \[Bisphosphonates and Denosumab are allowed concomitant medications\].
•6. Prior chemotherapy for prostate cancer with the exception of:
•* 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
•7. Prior exposure to bone directed radioisotope therapy, eg samarium 153, strontium 90;
•8. 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®).
+6 more criteria

Locations (7)

Cork University Hospital

Cork, Ireland

Mater Misericordiae University Hospital

Dublin, Ireland

Mater Private Hospital

Dublin, Ireland

SLRON, St James's Hospital

Dublin, Ireland

St Vincents University Hospital / AMNCH

Dublin, Ireland

Tallaght Hospital

Dublin, Ireland

Galway University Hospital

Galway, Ireland

Key Dates

Start Date

June 3, 2015

Primary Completion Date

July 1, 2017

Completion Date

November 23, 2021

Last Updated

April 6, 2023

Enrollment

ACTUAL participants

Conditions

Prostate Cancer

Interventions

Radium-223 and enzalutamide

DRUG

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

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Metastatic Castration-Resistant Prostate Cancer

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RECRUITINGPHASE2

Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells

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Metastatic Prostate Adenocarcinoma With Neuroendocrine DifferentiationMetastatic Prostate Neuroendocrine Carcinoma+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 6, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Radium-223 in Combination With Enzalutamide

Inclusion Criteria

Exclusion Criteria

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

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