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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.
Active, not recruiting
Ages:18 and older
DISEASE CHARACTERISTICS: Inclusion criteria: - 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 Exclusion criteria: - 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
Sponsor: Radiation Therapy Oncology Group
Phase: Phase 2
Trial ID: NCT00551525
Not Accepting Healthy Volunteers