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
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Radiotherapy; Samarium 153
Intervention description: 3D-CRT or IMRT 64.8-70.2 Gy to the prostatic fossa begins 12 weeks (+/- 1 week) after Samarium 153 administration. Daily tumor doses of 1.8 - 2.0 Gy per day, 5 days per week x 7-8 weeks.; Samarium 153 lexidronam dose 2.0 mCi/kg by IV injection one time within 2 weeks (+/- 3days) after registration.
Intervention MeSH terms: Samarium Sm-153 lexidronam
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 67.0
Sex: Male
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: stage IIB prostate cancer; stage IIA prostate cancer; stage III prostate cancer; stage IV 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.
    

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