I-131-1095 Radioligand Plus Enzalutamide vs Enzalutamide for mCRPC That Progressed During Abiraterone (ARROW).

PHASE2CompletedINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

May 30, 2019

Primary Completion Date

September 21, 2023

Study Completion Date

September 24, 2024

Conditions
Metastatic Prostate CancerCastration-resistant Prostate CancerProstatic NeoplasmCancer of the ProstateProgressive mCRPC
Interventions
DRUG

I-131-1095

Participants received up to 4 (8-week) cycles of I-131-1095: 100 mCi for the first dose. Subsequent dose(s) were reduced to 75 mCi for participants experiencing any dose-limiting toxicities. The third and fourth therapeutic doses could be reduced to 75 mCi on the basis of dosimetry assessment after administration of 10 mCi of I-131-1095 prior to the third dosing cycle. Participants also received the label dosage of enzalutamide once daily for up to 53 weeks.

DRUG

Enzalutamide

Participants received the label dosage of enzalutamide once daily for up to 53 weeks.

Trial Locations (27)

13210

SUNY Upstate Medical University, Syracuse

19104

University of Pennsylvania, Philadelphia

20007

Medstar Georgetown University Hospital, Washington D.C.

21201

University of Maryland, Baltimore

22908

University of Virginia Cancer Center, Charlottesville

29425

Medical University of South Carolina, Charleston

48109

University of Michigan Comprehensive Cancer Center, Ann Arbor

52242

University of Iowa, Iowa City

60637

The University of Chicago, Chicago

63110

Washington University School of Medicine, St Louis

70112

Tulane Medical School, New Orleans

77030

University of Texas MD Anderson Cancer Center, Houston

90073

VA Greater Los Angeles Healthcare System, Los Angeles

91010

City of Hope, Duarte

92663

Hoag Family Cancer Institute, Newport Beach

94303

VA Palo Alto Healthcare System, Palo Alto

98101

Virginia Mason Medical Center, Seattle

98109

University of Washington - Seattle Cancer Care Alliance, Seattle

90095-7370

UCLA, Los Angeles

09206

LifeSpan Cancer Institute, Providence

K1H 8L6

The Ottawa Hospital, Ottawa

Unknown

London Health Sciences Centre, Toronto

University Health Network - Princess Margaret Cancer Centre, Toronto

Centre Hospitalier Del' Universite de Montreal, Montreal

Jewish General Hospital, Montreal

Centre Hospitalier Universitaire de Quebec, Québec

Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke

All Listed Sponsors
lead

Progenics Pharmaceuticals, Inc.

INDUSTRY

NCT03939689 - I-131-1095 Radioligand Plus Enzalutamide vs Enzalutamide for mCRPC That Progressed During Abiraterone (ARROW). | Biotech Hunter | Biotech Hunter