Docetaxel, Androgen Ablation, and External-Beam Radiation Therapy in Patients With High-Risk Localized Prostate Cancer

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

23

Participants

Timeline

Start Date

August 31, 2005

Primary Completion Date

June 30, 2010

Study Completion Date

August 31, 2012

Conditions
Prostate Cancer
Interventions
DRUG

docetaxel

Docetaxel will be administered per the designated cohort starting at 10 mg/m2 intravenously over 1 hour weekly for eight weeks, for a total of eight treatments.

DRUG

leuprolide acetate

Leuprolide acetate will be administered at 22.5 mg IM and will be initiated 2 to 3 months prior to radiotherapy and chemotherapy with docetaxel.

RADIATION

radiation therapy

The total dose will be 7800 cGy in 200 centigray (cGy) per fraction for a total of 39 treatments.

Trial Locations (2)

27607

Rex Cancer Center at Rex Hospital, Raleigh

27599-7295

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Sanofi

INDUSTRY

lead

UNC Lineberger Comprehensive Cancer Center

OTHER