A Randomized Phase IIa Efficacy and Safety Study of Radium-223 Dichloride With Abiraterone Acetate or Enzalutamide in Metastatic Castration-resistant Prostate Cancer (CRPC)

PHASE2CompletedINTERVENTIONAL
Enrollment

68

Participants

Timeline

Start Date

March 7, 2014

Primary Completion Date

July 15, 2016

Study Completion Date

June 26, 2018

Conditions
Prostatic Neoplasms
Interventions
DRUG

Radium-223 dichloride (Xofigo, BAY88-8223)

Radium-223 dichloride (Xofigo, BAY88-8223) 50 kBq/kg (55 kBq/kg after implementation of NIST \[National Institute of Standards and Technology\] update) every 4 weeks x 6 doses intravenous slow bolus

DRUG

Abiraterone acetate

Abiraterone acetate 1000 mg (4 x 250 mg tablets) taken orally once daily for up to two years following last dose of radium-223 dichloride

DRUG

Prednisone

Prednisone 5 mg capsule taken orally twice daily for up to two years following last dose of radium-223 dichloride

DRUG

Enzalutamide

Enzalutamide 160 mg (four 40 mg capsules) taken orally once daily for up to two years following last dose of radium-223 dichloride

Trial Locations (19)

13210

Syracuse

19713

Newark

20007

Washington D.C.

20850

Rockville

33324

Plantation

46202

Indianapolis

48201

Detroit

63110

St Louis

68130

Omaha

70112

New Orleans

71103

Shreveport

77027

Houston

85251

Scottsdale

85704

Tucson

90033

Los Angeles

97477

Springfield

98109

Seattle

06520

New Haven

10467-2490

The Bronx

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY

NCT02034552 - A Randomized Phase IIa Efficacy and Safety Study of Radium-223 Dichloride With Abiraterone Acetate or Enzalutamide in Metastatic Castration-resistant Prostate Cancer (CRPC) | Biotech Hunter | Biotech Hunter