Clinical Trial · NCT02097303

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

Overview

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.

Sponsor

Unknown Organization

Phase

Phase 2

Contacts

Neal D Shore, MD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT02097303

Drug / Compound

Radium-223 dichloride

Isotope(s):

Target(s):

No Explicit Target

Ligand Class: Small Molecules

Eligibility

Inclusion

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.
Eligible subjects will conform to all of the inclusion criteria listed below:
Subject is willing and able to comply with the protocol, including all study visits and procedures.
Life expectancy of at least 9 months.
Subject is a male, greater than 18 years at time of enrollment.

Exclusion

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.
Eligible subjects must not meet any of the exclusion criteria listed below:
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).
Subject has a known medical contraindication to Prednisone, Abiraterone Acetate or Radium Ra 223 dichloride.
Subject has a history of visceral metastatic disease as assessed by abdominal/pelvic CT or chest x-ray within the previous 8 weeks.