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

Conditions: Prostate Cancer

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.

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 criteria:
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

Keywords: stage iib prostate cancer stage iia prostate cancer stage iii prostate cancer stage iv prostate cancer