Docetaxel, Radiation Therapy, and Hormone Therapy in Treating Patients With Locally Advanced Prostate Cancer

PHASE1CompletedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

January 16, 2007

Primary Completion Date

January 20, 2011

Study Completion Date

December 13, 2023

Conditions
Prostate Cancer
Interventions
DRUG

Bicalutamide

Bicalutamide will be administered for approximately 28 months: prior to radiotherapy (2 months), during radiotherapy (2 months), and after radiotherapy (24 months)

DRUG

docetaxel

Docetaxel will be administered weekly during radiotherapy. The docetaxel dose will be escalated as part of the study. Dose levels are: 10mg/m2; 15 mg/m2; 20 mg/m2 and 25 mg/m2

DRUG

GnRh analog

"A GnRH analog (goserelin acetate, leuprolide acetate) will be administered for approximately 28 months: prior to radiotherapy (2 months), during radiotherapy (2 months), and after radiotherapy (24 months)~Bicalutamide will be administered for approximately 28 months: prior to radiotherapy (2 months), during radiotherapy (2 months), and after radiotherapy (24 months)"

RADIATION

radiotherapy

External beam photon radiotherapy utilizing 3-D-conformal or intensity modulated radiotherapy (IMRT) shall be used to deliver 77.4 4 Gy in 43 fractions of 1.8 Gy fractions.

All Listed Sponsors
lead

Medical University of South Carolina

OTHER

NCT00099086 - Docetaxel, Radiation Therapy, and Hormone Therapy in Treating Patients With Locally Advanced Prostate Cancer | Biotech Hunter | Biotech Hunter