NCT00328614 - Samarium-153 With Neoadjuvant Hormonal and Radiation Therapy for Locally Advanced Prostate Cancer | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

March 31, 2003

Primary Completion Date

February 28, 2009

Study Completion Date

June 30, 2011

Conditions

Prostate Cancer

Interventions

DRUG

Samarium-153

Samarium-153 will be administered as a single dose after one month of hormonal therapy. The dose level of Samarium-153 may change to determine maximum tolerated dose (MTD).

DRUG

Total Androgen Suppression (TAS) with Bicalutamide

Patients will receive 5 months of total androgen suppression (TAS) consisting of Zoladex and Casodex. Total androgen suppression will begin 3 months prior to initiation of irradiation.

DRUG

Total androgen suppression (TAS) with Goserelin Acetate

Patients will receive 5 months of total androgen suppression (TAS) consisting of Zoladex and Casodex. Total androgen suppression will begin 3 months prior to initiation of irradiation.

DEVICE

Radiation Therapy

Radiation therapy will begin 3 months following the initiation of hormone administration. Daily tumor doses will be given 5 days per week for 7-8 weeks.

Trial Locations (1)

19107

Thomas Jefferson University, Philadelphia