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
OBJECTIVES:
Primary
- 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
cancer.
Secondary
- 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
Nomograms.
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.
Interventional
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.
No
Richard K. Valicenti, MD
Principal Investigator
Kimmel Cancer Center (KCC)
United States: Federal Government
RTOG-0622
NCT00551525
April 2008
Name | Location |
---|---|
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 |