Prostate Cancer
Conditions
Keywords
stage I prostate cancer, stage II prostate cancer, stage III prostate cancer, stage IV prostate cancer
Brief summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Using scintigraphy to plan specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. PURPOSE: This phase I/II trial is studying the side effects and best way to give intensity-modulated radiation therapy and to see how well it works in treating patients with stage I, stage II, stage III, or stage IV prostate cancer.
Detailed description
OBJECTIVES: * To assess the feasibility of radioimmunoguided intensity-modulated radiotherapy (IMRT) for stage I-IV prostate cancer. * To determine the toxicity and tolerance of this regimen in these patients. * To determine the tumor response based on physical examination and serial measurements of the serum prostate-specific antigen (PSA) levels in these patients. * To determine the outcome of patients treated on this study with radioimmunoguided IMRT compared to 2 control groups of patients treated at Mayo Scottsdale Clinic (MSC). OUTLINE: Patients undergo radioimmunoguided intensity-modulated radiotherapy once daily, 5 days a week for 8½ weeks. Beginning the last week of radiotherapy, some patients receive leuprolide acetate intramuscularly every 3-4 months or goserelin subcutaneously every 3 months for 6 months, 12 months, or until disease progression. After completion of study treatment, patients are followed every 3-4 months for 1 year, every 6 months for 4 years and annually thereafter
Interventions
DRUGgoserelin acetate
DRUGleuprolide acetate
RADIATIONimage-guided radiation therapy
RADIATIONintensity-modulated radiation therapy
Sponsors
National Cancer Institute (NCI)
Mayo Clinic
Study design
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Pathologically confirmed prostate cancer * Stage I-IV disease (T1-4, N0-1, M0) * No evidence of distant metastases (M0) on physical examination or bone scan PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Hemoglobin ≥ 10.0 g/dL * WBC ≥ 3,000/mcL * Platelet count ≥ 90,000/mm * AST \< 2 times the upper limit of normal * No allergy to leuprolide acetate or goserelin PRIOR CONCURRENT THERAPY: * Not specified
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of outcomes to patients treated with conventional radiotherapy and intensity-modulated radiotherapy without radioimmunoguidance | — |
| Distant failure rates | — |
| Biochemical freedom from failure rates | — |
| Toxicity | — |
| Survival rates | — |
| Freedom from biochemical relapse rates | — |
| Local control rates | — |
Secondary
| Measure | Time frame |
|---|---|
| Sexual health as assessed by inventory questionnaire | — |
| Obstructive urinary symptoms | — |
Countries
United States
Outcome results
None listed