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Open Label Phase Two Trial of Radium Ra 223 Dichloride With Concurrent Administration of Abiraterone Acetate Plus Prednisone in Symptomatic Castration-Resistant (Hormone-Refractory) Prostate Cancer Subjects With Bone Metastasis | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Open Label Phase Two Trial of Radium Ra 223 Dichloride With Concurrent Administration of Abiraterone Acetate Plus Prednisone in Symptomatic Castration-Resistant (Hormone-Refractory) Prostate Cancer Subjects With Bone Metastasis

NCT02097303•Carolina Research Professionals, LLC

View on ClinicalTrials.gov

Summary

This is an open label study designed to examine the effects on concurrent administration of Radium Ra 223 dichloride and Abiraterone Acetate plus Prednisone in subjects with symptomatic castrate resistant prostate cancer and with bone metastases, in both the pre- and post- chemotherapy setting. Both medications are approved by the US Food and Drug Administration for this indication.

Detailed Description

Approximately 40 subjects will be enrolled to obtain 30 evaluable subjects. All subjects will receive Radium Ra 223 dichloride every 4 weeks for a total of 6 doses over 24 weeks and concurrent Abiraterone Acetate plus Prednisone for a minimum duration of 26 weeks. Subjects will be evaluated 30 days after the last dose of Radium Ra 223 dichloride. All adverse events deemed to be study related will be followed until resolution. Including screening, the total duration of the study is 32 weeks.

Eligibility

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•1. Subject must be able to understand and be willing to sign the written informed consent form. A signed informed consent form must be appropriately obtained prior to the conduct of any trial-specific procedure.
•2. Subject is willing and able to comply with the protocol, including all study visits and procedures.
•3. Subject is a male, greater than 18 years at time of enrollment.
•4. Life expectancy of at least 9 months.
•5. Subject has histologically documented prostate cancer confirmed by a pathology report from a prostate biopsy or radical prostatectomy specimen.
•6. Subject must:
•• have initiated a stable dose of daily Abiraterone Acetate plus Prednisone within 90 days of enrollment, or
•• plans to initiate a stable daily dose of Abiraterone plus Prednisone within 30 days of the first Radium Ra 223 dichloride treatment.
•7. Subject must plan to receive all 6 Radium Ra 223 dichloride injections and daily oral doses of Abiraterone plus Prednisone during the trial, per protocol.
•8. Subject has a history of bone metastasis from prostate cancer as evidenced by imaging performed within 90 days of enrollment from one of the following:
+19 more criteria

Exclusion Criteria

•1. Subject has known malignant pleural effusion, or known lung, liver or brain metastasis (lymph node only metastasis \< 6 cm in short-axis diameter is allowed).
•2. Subject has a history of visceral metastatic disease as assessed by abdominal/pelvic CT or chest x-ray within the previous 8 weeks.
•3. Subject has received previous treatment with Abiraterone Acetate for longer than 90 days prior to enrollment, or any prior treatment with Radium Ra 223 dichloride.
•4. Subject has a known medical contraindication to Prednisone, Abiraterone Acetate or Radium Ra 223 dichloride.
•5. Subject is not willing to initiate a stable dose of daily Abiraterone Acetate plus Prednisone within 90 days of enrollment, or does not plan to initiate a stable daily dose of Abiraterone Acetate plus Prednisone within 30 days of the first Radium Ra 223 dichloride treatment.
•6. Subject does not plan to receive all 6 infusions of Radium Ra 223 Dichloride and daily Abiraterone Acetate plus Prednisone during the trial, per protocol.
•7. Subject has received previous strontium-89, samarium-153, rhenium-186, or rhenium-188 for the treatment of bone metastasis within 24 weeks prior to enrollment.
•8. Subject has received denosumab or Zolendronic Acid for less than 90 days prior to enrollment, or if the subject plans to discontinue an anti-resorptive medication prior to the EOT visit.
•9. Subject has received an investigational product or experimental therapy within 4 weeks of enrollment, or if initiation of either is planned prior to the EOT visit.
•10. Subject has had treatment with cytotoxic chemotherapy within the previous 4 weeks, or planned prior to the End of Treatment visit, or failure to recover from adverse events due to cytotoxic chemotherapy administered more than 4 weeks prior to enrollment (persistent myelosuppression, GI toxicity, or severe fatigue (ongoing neuropathy is not exclusionary).
+13 more criteria

Locations (5)

Chesapeake urology Research Associates

Towson, Maryland, United States

Urology Cancer Center and GU Research Network

Omaha, Nebraska, United States

Associated Medical Professionals

Syracuse, New York, United States

Oregon Urology Institute

Springfield, Oregon, United States

Carolina Urologic Research Center

Myrtle Beach, South Carolina, United States

Key Dates

Start Date

March 1, 2014

Primary Completion Date

December 1, 2015

Completion Date

December 1, 2015

Last Updated

February 1, 2018

Enrollment

ACTUAL participants

Conditions

Prostate Cancer

Interventions

Concurrent use of Radium Ra 223 dichloride and Abiraterone Acetate plus Prednisone

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RECRUITINGPHASE2

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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: February 1, 2018Data 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.

View ClinicalTrials.gov Terms and Conditions

Open Label Phase Two Trial of Radium Ra 223 Dichloride With Concurrent Administration of Abiraterone Acetate Plus Prednisone in Symptomatic Castration-Resistant (Hormone-Refractory) Prostate Cancer Subjects With Bone Metastasis

Inclusion Criteria

Exclusion Criteria

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

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

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