- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00653757
Intensity-Modulated Radiation Therapy in Treating Patients With Stage I, Stage II, Stage III, or Stage IV Prostate Cancer
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.
Study Overview
Status
Conditions
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
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
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Arizona
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Scottsdale, Arizona, United States
- Mayo Clinic in Arizona
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Toxicity
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Local control rates
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Survival rates
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Freedom from biochemical relapse rates
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Distant failure rates
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Biochemical freedom from failure rates
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Comparison of outcomes to patients treated with conventional radiotherapy and intensity-modulated radiotherapy without radioimmunoguidance
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Secondary Outcome Measures
Outcome Measure |
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Obstructive urinary symptoms
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Sexual health as assessed by inventory questionnaire
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Steven E. Schild, M.D., Mayo Clinic
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDR0000588847
- P30CA015083 (U.S. NIH Grant/Contract)
- 390-02 (Mayo Clinic IRB)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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