A Phase II Trial of Samarium 153 Followed by Salvage Prostatic Fossa 3D-CRT or IMRT Irradiation in High-Risk, Clinically Non-Metastatic Prostate Cancer After Radical Prostatectomy
- To assess the effectiveness of samarium Sm 153 lexidronam pentasodium (as determined by
a 30% decline in the PSA level within 12 weeks) followed by either three-dimensional
conformal radiation therapy or intensity-modulated radiation therapy in patients with
rising prostate-specific antigen levels (PSA) after radical prostatectomy prostate
- To assess the proportion of patients completing protocol treatment.
- To evaluate hematological toxicity at 12 weeks.
- To evaluate samarium Sm 153 lexidronam pentasodium-related adverse events at 12 weeks.
- To evaluate the "acute" and "late" radiation therapy-related events having occurred up
to 24 weeks from the end of radiation therapy.
- To compare the freedom from progression rate at 2 years to that predicted by the Kattan
OUTLINE: Patients receive samarium Sm 153 lexidronam pentasodium (SM) IV on day 1. Patients
are closely monitored for prostate-specific antigen (PSA) level and SM-associated toxicity
for 12 weeks. After the 12 weeks, patients undergo either intensity-modulated radiation
therapy or 3-dimensional conformal radiation therapy 5 days a week for 7-8 weeks. Patients
may receive hormonal therapy (after radiation therapy) at the discretion of their physician.
Treatment continues in the absence of disease progression (defined as a PSA doubling time
less than 3 months), severe thrombocytopenia (defined as a platelet count of 25,000
cells/mm³ or less), or unacceptable toxicity.
After completion of study treatment, patients are followed up at 3 months, 6 months, and 12
months, every 6 months for 2 years, and then annually thereafter.
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The effectiveness of Samarium 153
Twelve weeks fro the date of Samarium 153 infusion.
Richard K. Valicenti, MD
Kimmel Cancer Center (KCC)
United States: Federal Government
|CCOP - Christiana Care Health Services||Wilmington, Delaware 19899|
|West Michigan Cancer Center||Kalamazoo, Michigan 49007-3731|
|Kaiser Permanente Medical Center - Los Angeles||Los Angeles, California 90027|
|Kimmel Cancer Center at Thomas Jefferson University - Philadelphia||Philadelphia, Pennsylvania 19107|
|University of California Davis Cancer Center||Sacramento, California 95817|
|McDowell Cancer Center at Akron General Medical Center||Akron, Ohio 44307|
|University of Florida Shands Cancer Center||Gainesville, Florida 32610-0232|
|Stony Brook University Cancer Center||Stony Brook, New York 11794-8174|
|David C. Pratt Cancer Center at St. John's Mercy||St. Louis, Missouri 63141|
|Tulane Cancer Center Office of Clinical Research||Alexandria, Louisiana 71315-3198|
|Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis||St. Louis, Missouri 63110|
|Oklahoma University Cancer Institute||Oklahoma City, Oklahoma 73104|
|Regional Cancer Center at Singing River Hospital||Pascagoula, Mississippi 39581|
|John B. Amos Cancer Center||Columbus, Georgia 31904|
|Billings Clinic - Downtown||Billings, Montana 59107-7000|
|Summa Center for Cancer Care at Akron City Hospital||Akron, Ohio 44309-2090|
|Barberton Citizens Hospital||Barberton, Ohio 44203|
|Arizona Oncology Services Foundation||Phoenix, Arizona 85013|
|Radiological Associates of Sacramento Medical Group, Incorporated||Sacramento, California 95815|
|Sentara Cancer Institute at Sentara Norfolk General Hospital||Norfolk, Virginia 23507|
|Solano Radiation Oncology Center||Vacaville, California 95687|
|Mercy General Hospital||Sacramento, California 95819|
|Hudner Oncology Center at Saint Anne's Hospital - Fall River||Fall River, Massachusetts 02721|
|Auburn Radiation Oncology||Auburn, California 95603|
|Radiation Oncology Centers - Cameron Park||Cameron Park, California 95682|
|Radiation Oncology Center - Roseville||Roseville, California 95661|
|Mercy Cancer Center at Mercy San Juan Medical Center||Carmichael, California 95608|
|Robinson Radiation Oncology||Ravenna, Ohio 44266|
|Coastal Cancer Center at Sentara Virginia Beach General Hospital||Virginia Beach, Virginia 23454|