A Phase I Pilot Study of Samarium-153 Combined With Neoadjuvant Hormonal Therapy and Radiation Therapy in Men With Locally Advanced Prostate Cancer
Sponsor study identifier
Secondary identifiers
OTHER · CCRRC
OTHER · JeffTrial Number
interventional
32
1 country
1
Study Start
March 2003
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2009
Actual (reported)Study Completion
June 2011
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2011
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2003
Date type not reportedThis date has not been verified as actual or estimated.
May 19, 2006
Actual (reported)May 22, 2006
Actual (reported)February 2009
Actual (reported)June 2011
Actual (reported)November 8, 2013
Actual (reported)Maximum Tolerated Dose of Samarium-153
To determine the maximum tolerated dose (MTD) of Samarium as adjuvant to combined hormonal therapy (HT) and external beam radiation therapy (RT). Dose levels: Dose I: 0.25 mCi/kg IV Dose II: 0.5 mCi/kg IV Dose III: 0.75 mCi/kg IV Dose IV: 1.0 mCi/kg IV Dose V: 1.5 mCi/kg IV Dose VI: 2.0 mCi/kg IV Dose-limiting toxicity will be defined as Grade 3 hematologic toxicity per NCI Common Toxicity Criteria. The maximally tolerated dose (MTD) will then be the last dose studied or the previous dose, based on clinical judgment of the degree of toxicity seen at the last dose.
5 months (1 month HT, administration of drug, 4 months HT and RT)
Cohort 1: Patients receive 0.25 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
Cohort 2: Patients receive 0.5 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
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).
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Edouard Trabulsi, MD
Thomas Jefferson University
Richard Valicenti, MD, MA
UC Davis School of Medicine
32 participants (actual enrollment reported by the registry).
First Submitted
May 19, 2006
First Posted
May 22, 2006
Study Start
March 2003
Date type not reportedThis date has not been verified as actual or estimated.
Cohort 3: Patients receive 0.75 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
Cohort 4: Patients receive 1.0 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
Cohort 5: Patients receive 1.5 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
Cohort 6: Patients receive 2.0 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
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.
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 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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
February 2009
Actual (reported)Study Completion
June 2011
Actual (reported)Last Updated
May 16, 2025
Results First Posted
November 8, 2013
Record last verified: 2025-05
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Source: ClinicalTrials.gov.
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