A Phase I Pilot Study of Samarium-153 Combined With Neoadjuvant Hormonal Therapy and Radiation Therapy in Men With Locally Advanced Prostate Cancer
The likelihood of prostate cancer cells metastasizing to bone has an early and important
influence on the natural history of prostate cancer. Bone-targeted therapy, when given
sequentially with hormonal therapy (androgen suppression) and radiation therapy, prolongs
the progression of the disease in clinically non-metastatic prostate cancer patients.
The use of Samarium-153 EDTMP in conjunction with hormonal therapy and external beam
radiation therapy has never been previously evaluated in high risk clinically localized
prostate cancer. Many patients with high-risk prostate cancer develop progressive disease
within 2 years of therapy indicating that subclinical metastatic disease may be present at
the time of initial diagnosis. In these high-risk patients, there may be a therapeutic
benefit of combining hormonal therapy with external beam radiation therapy and Samarium-153
EDTMP to treat localized and subclinical bony disease, respectively.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety of Samarium-153 EDTMP
To assess the safety of Samarium-153 EDTMP administered intravenously in a single dose after one month of TAS and two months prior to starting external beam radiation therapy in patients with high-risk clinically localized prostate cancer.
30 days post-treatment
Edouard Trabulsi, MD
Thomas Jefferson University
United States: Institutional Review Board
|Thomas Jefferson University||Philadelphia, Pennsylvania 19107-6541|