CompletedPhase 2

Radium-223 in Combination With Enzalutamide

Ireland45 participantsStarted 2015-06-03

Plain-language 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.

Who can participate

Age range18 Years

SexMALE

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Inclusion criteria

✓. 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:
✓. 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).
✓. 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).

Exclusion criteria

✕. 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:
✕. 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®).

What they're measuring

To determine safety

Timeframe: approximately 6 to 9 months

Trial details

NCT IDNCT02225704

SponsorCancer Trials Ireland

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2017-07

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