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

Completed · Phase 2

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT00551525

Run by

Radiation Therapy Oncology Group

People needed

67

Starts

2008-04-01

Expected to finish

2016-12-01

Last updated by the study team

2017-07-25

Who can join

Age: 18 and older, up to 120. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Histologically proven diagnosis of prostate cancer progressing after prior radical prostatectomy as indicated by one of the following:
• Postoperative prostate-specific antigen (PSA) rising above 1.0 ng/mL
• Postoperative PSA rising above 0.2 ng/mL with a surgical tumor Gleason score of 9 or 10
• Postoperative PSA rising above 0.2 ng/ml with nodal disease
• Stage II-IV disease (T2 -T4, N0-N1)
• No distant metastases based on the following minimum diagnostic work up:
• History or physical examination within the past 8 weeks
• Bone scan negative for bone metastases within the past 4 months
• Abdominal imaging negative for metastases within the past 6 months

You may not qualify if…

• Biopsy evidence of M1 disease
• Presence of neuroendocrine features in any prostate cancer specimen
• PATIENT CHARACTERISTICS:
• Inclusion criteria:
• Zubrod Performance Status 0-1
• Absolute neutrophil count (ANC) ≥ 1,800 cells/mm³
• Platelet count ≥ 100,000 cells/mm³
• Hemoglobin ≥ 8.0 g/dL (transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is permitted)
• Exclusion criteria:
• Prior invasive malignancy (except nonmelanoma skin cancer) unless disease free for a minimum of 3 years
• Severe, active comorbidity, defined as follows:
• Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
• Transmural myocardial infarction within the last 6 months
• Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
• Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects (laboratory tests for liver function and coagulation parameters, however, are not required for entry into this protocol)
• Renal failure (laboratory tests for renal function, however, are not required for entry into this protocol)
• AIDS based upon current Centers for Disease Control (CDC) definition (HIV testing is not required)
• PRIOR CONCURRENT THERAPY:
• No prior systemic chemotherapy for the study cancer
• Prior chemotherapy for a different cancer is permitted
• No hormonal therapy initiated within the last 3 months
• No prior radiotherapy to the pelvic region that would result in overlap of radiotherapy fields

Where it is running

• 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 — St Louis, Missouri, United States
• David C. Pratt Cancer Center at St. John's Mercy — St 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

Full record on ClinicalTrials.gov

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