Intensity-Modulated Radiation Therapy in Treating Patients With Stage I, Stage II, Stage III, or Stage IV Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT00653757|
Recruitment Status : Completed
First Posted : April 7, 2008
Last Update Posted : March 19, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: goserelin acetate Drug: leuprolide acetate Radiation: image-guided radiation therapy Radiation: intensity-modulated radiation therapy||Phase 1 Phase 2|
- 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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Masking:||None (Open Label)|
|Official Title:||Phase I/II Study of Radioimmunoguided Intensity Modulated Radiotherapy (IMRT) for Prostate Cancer|
|Study Start Date :||March 2002|
|Actual Primary Completion Date :||December 2006|
|Actual Study Completion Date :||December 2007|
- Survival rates
- Freedom from biochemical relapse rates
- Local control rates
- Distant failure rates
- Biochemical freedom from failure rates
- Comparison of outcomes to patients treated with conventional radiotherapy and intensity-modulated radiotherapy without radioimmunoguidance
- Obstructive urinary symptoms
- Sexual health as assessed by inventory questionnaire
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00653757
|United States, Arizona|
|Mayo Clinic in Arizona|
|Scottsdale, Arizona, United States|
|Study Chair:||Steven E. Schild, M.D.||Mayo Clinic|