CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 32 enrolled
Drug / intervention
Samarium-153 +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00328614
NCT00328614Phase 1Completed
CompareCT.gov

A Phase I Pilot Study of Samarium-153 Combined With Neoadjuvant Hormonal Therapy and Radiation Therapy in Men With Locally Advanced Prostate Cancer

Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University·interventional·Posted May 22, 2006·Updated May 16, 2025

In Brief

A Phase 1 clinical trial evaluating Samarium-153, Total Androgen Suppression (TAS) with Bicalutamide, and 2 other interventions for Prostate Cancer. Completed, enrolled 32 participants across 1 site.

Detailed Summary

The purpose of this study is to determine the safety and effectiveness of Samarium-153 when given in combination with hormonal and external beam radiation therapy in men with high risk prostate cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesUnited States
CollaboratorsCytogen Corporation

Timeline

Phase 1CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 22, 2006
Enrollment StartMar 1, 2003
Primary CompletionFeb 1, 2009
Study CompletionJun 1, 2011
TodayJul 2, 2026
Enrollment to primary: 5.9 yearsPosted 20.1 years ago

Interventions

Samarium-153drug

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).

Total Androgen Suppression (TAS) with Bicalutamidedrug

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.

Total androgen suppression (TAS) with Goserelin Acetatedrug

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.

Radiation Therapydevice

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.