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Phase I/II Study of Radioimmunoguided Intensity Modulated Radiotherapy (IMRT) for 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.
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
Age
19 - No limit years
Sex
MALE
Healthy Volunteers
No
Mayo Clinic in Arizona
Scottsdale, Arizona, United States
Start Date
March 1, 2002
Primary Completion Date
December 1, 2006
Completion Date
December 1, 2007
Last Updated
March 19, 2012
100
ESTIMATED participants
goserelin acetate
DRUG
leuprolide acetate
DRUG
image-guided radiation therapy
RADIATION
intensity-modulated radiation therapy
RADIATION
Lead Sponsor
Mayo Clinic
Collaborators
NCT06842498
NCT04550494
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05691465