Prostate Cancer Clinical Trial
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
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.
Full 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 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
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There are 29 Locations for this study
Phoenix Arizona, 85013, United States
Auburn California, 95603, United States
Cameron Park California, 95682, United States
Carmichael California, 95608, United States
Los Angeles California, 90027, United States
Roseville California, 95661, United States
Sacramento California, 95815, United States
Sacramento California, 95817, United States
Sacramento California, 95819, United States
Vacaville California, 95687, United States
Newark Delaware, 19713, United States
Gainesville Florida, 32610, United States
Columbus Georgia, 31904, United States
Alexandria Louisiana, 71315, United States
Fall River Massachusetts, 02721, United States
Kalamazoo Michigan, 49007, United States
Pascagoula Mississippi, 39581, United States
Saint Louis Missouri, 63110, United States
Saint Louis Missouri, 63141, United States
Billings Montana, 59107, United States
Stony Brook New York, 11794, United States
Akron Ohio, 44307, United States
Akron Ohio, 44309, United States
Barberton Ohio, 44203, United States
Ravenna Ohio, 44266, United States
Oklahoma City Oklahoma, 73104, United States
Philadelphia Pennsylvania, 19107, United States
Norfolk Virginia, 23507, United States
Virginia Beach Virginia, 23454, United States
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