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Intensity-Modulated Radiation Therapy in Treating Patients With Stage I, Stage II, Stage III, or Stage IV Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00653757
Recruitment Status : Completed
First Posted : April 7, 2008
Last Update Posted : March 19, 2012
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Mayo Clinic

Study Description
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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.


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

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Toxicity
  2. Survival rates
  3. Freedom from biochemical relapse rates
  4. Local control rates
  5. Distant failure rates
  6. Biochemical freedom from failure rates
  7. Comparison of outcomes to patients treated with conventional radiotherapy and intensity-modulated radiotherapy without radioimmunoguidance

Secondary Outcome Measures :
  1. Obstructive urinary symptoms
  2. Sexual health as assessed by inventory questionnaire

Eligibility Criteria
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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, Arizona
Mayo Clinic in Arizona
Scottsdale, Arizona, United States
Sponsors and Collaborators
Mayo Clinic
National Cancer Institute (NCI)
Investigators
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Study Chair: Steven E. Schild, M.D. Mayo Clinic
More Information
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Responsible Party: Steven E Schild, M.D., Mayo Clinic Cancer Center
ClinicalTrials.gov Identifier: NCT00653757    
Other Study ID Numbers: CDR0000588847
P30CA015083 ( U.S. NIH Grant/Contract )
390-02 ( Other Identifier: Mayo Clinic Cancer Center )
390-02 ( Other Identifier: Mayo Clinic IRB )
First Posted: April 7, 2008    Key Record Dates
Last Update Posted: March 19, 2012
Last Verified: March 2012
Keywords provided by Mayo Clinic:
stage I prostate cancer
stage II prostate cancer
stage III prostate cancer
stage IV prostate cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Leuprolide
 Goserelin
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents