Intensity-Modulated Radiation Therapy in Treating Patients With Stage I, Stage II, Stage III, or Stage IV Prostate Cancer
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.
Drug: goserelin acetate
Drug: leuprolide acetate
Radiation: image-guided radiation therapy
Radiation: intensity-modulated radiation therapy
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I/II Study of Radioimmunoguided Intensity Modulated Radiotherapy (IMRT) for Prostate Cancer|
- Toxicity [ Designated as safety issue: Yes ]
- Survival rates [ Designated as safety issue: Yes ]
- Freedom from biochemical relapse rates [ Designated as safety issue: No ]
- Local control rates [ Designated as safety issue: No ]
- Distant failure rates [ Designated as safety issue: No ]
- Biochemical freedom from failure rates [ Designated as safety issue: No ]
- Comparison of outcomes to patients treated with conventional radiotherapy and intensity-modulated radiotherapy without radioimmunoguidance [ Designated as safety issue: No ]
- Obstructive urinary symptoms [ Designated as safety issue: No ]
- Sexual health as assessed by inventory questionnaire [ Designated as safety issue: No ]
|Study Start Date:||March 2002|
|Study Completion Date:||December 2007|
|Primary Completion Date:||December 2006 (Final data collection date for primary outcome measure)|
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00653757
|United States, Arizona|
|Mayo Clinic in Arizona|
|Scottsdale, Arizona, United States|
|Study Chair:||Steven E. Schild, M.D.||Mayo Clinic|