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
Study type: Interventional
Phase: Phase 2

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.
    

Detailed 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.
    

Intervention name(s): Radiotherapy; Samarium 153
Intervention type(s): Radiation; Drug
Intervention description(s): 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.
Other intervention name(s): 3D-CRT; IMRT; Intensity-modulated radiation therapy; Samarium sm 153 lexidronam pentasodium; Quadramet
Intervention MeSH terms: Samarium Sm-153 lexidronam
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage IIB prostate cancer; stage IIA prostate cancer; stage III prostate cancer; stage IV prostate cancer