Spots Global Cancer Trial Database for Samarium Sm 153 Lexidronam Pentasodium and 3-Dimensional Conformal Radiation Therapy or Intensity-Modulated Radiation Therapy in Treating Patients With Rising Prostate-Specific Antigen Levels After Radical Prostatectomy for Prostate Cancer
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Trial Identification
Brief Title: Samarium Sm 153 Lexidronam Pentasodium and 3-Dimensional Conformal Radiation Therapy or Intensity-Modulated Radiation Therapy in Treating Patients With Rising Prostate-Specific Antigen Levels After Radical Prostatectomy for Prostate Cancer
Official Title: 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
Study ID: NCT00551525
Conditions
Study Description
Brief Summary: RATIONALE: Giving samarium Sm 153 lexidronam pentasodium and 3-dimensional (3-D) conformal radiation therapy or intensity-modulated radiation therapy may keep prostate cancer from growing in patients with rising prostate-specific antigen (PSA) levels after radical prostatectomy for prostate cancer. PURPOSE: This phase II trial is studying how well samarium Sm 153 lexidronam pentasodium and 3-D conformal radiation therapy or intensity-modulated radiation therapy work in treating patients with rising PSA levels after radical prostatectomy for prostate cancer.
Detailed Description: 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
Arizona Oncology Services Foundation, Phoenix, Arizona, United States
Auburn Radiation Oncology, Auburn, California, United States
Radiation Oncology Centers - Cameron Park, Cameron Park, California, United States
Mercy Cancer Center at Mercy San Juan Medical Center, Carmichael, California, United States
Kaiser Permanente Medical Center - Los Angeles, Los Angeles, California, United States
Radiation Oncology Center - Roseville, Roseville, California, United States
Radiological Associates of Sacramento Medical Group, Incorporated, Sacramento, California, United States
University of California Davis Cancer Center, Sacramento, California, United States
Mercy General Hospital, Sacramento, California, United States
Solano Radiation Oncology Center, Vacaville, California, United States
CCOP - Christiana Care Health Services, Newark, Delaware, United States
University of Florida Shands Cancer Center, Gainesville, Florida, United States
John B. Amos Cancer Center, Columbus, Georgia, United States
Tulane Cancer Center Office of Clinical Research, Alexandria, Louisiana, United States
Hudner Oncology Center at Saint Anne's Hospital - Fall River, Fall River, Massachusetts, United States
West Michigan Cancer Center, Kalamazoo, Michigan, United States
Regional Cancer Center at Singing River Hospital, Pascagoula, Mississippi, United States
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis, Saint Louis, Missouri, United States
David C. Pratt Cancer Center at St. John's Mercy, Saint Louis, Missouri, United States
Billings Clinic - Downtown, Billings, Montana, United States
Stony Brook University Cancer Center, Stony Brook, New York, United States
McDowell Cancer Center at Akron General Medical Center, Akron, Ohio, United States
Summa Center for Cancer Care at Akron City Hospital, Akron, Ohio, United States
Barberton Citizens Hospital, Barberton, Ohio, United States
Robinson Radiation Oncology, Ravenna, Ohio, United States
Oklahoma University Cancer Institute, Oklahoma City, Oklahoma, United States
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia, Philadelphia, Pennsylvania, United States
Sentara Cancer Institute at Sentara Norfolk General Hospital, Norfolk, Virginia, United States
Coastal Cancer Center at Sentara Virginia Beach General Hospital, Virginia Beach, Virginia, United States
Contact Details
Name: Richard K. Valicenti, MD
Affiliation: Sidney Kimmel Cancer Center at Thomas Jefferson University
Role: PRINCIPAL_INVESTIGATOR
Name: Oliver Sartor, MD
Affiliation: Dana-Farber Cancer Institute
Role: STUDY_CHAIR
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