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

This study has been completed.
National Cancer Institute (NCI)
Information provided by:
Mayo Clinic Identifier:
First received: April 4, 2008
Last updated: March 15, 2012
Last verified: March 2012

April 4, 2008
March 15, 2012
March 2002
December 2006   (Final data collection date for primary outcome measure)
  • Toxicity
  • 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
Same as current
Complete list of historical versions of study NCT00653757 on Archive Site
  • Obstructive urinary symptoms
  • Sexual health as assessed by inventory questionnaire
Same as current
Not Provided
Not Provided
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.


  • 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

Phase 1
Phase 2
Masking: Open Label
Primary Purpose: Treatment
Prostate Cancer
  • Drug: goserelin acetate
  • Drug: leuprolide acetate
  • Radiation: image-guided radiation therapy
  • Radiation: intensity-modulated radiation therapy
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
December 2007
December 2006   (Final data collection date for primary outcome measure)


  • 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


  • 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


  • Not specified
Sexes Eligible for Study: Male
19 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
P30CA015083 ( US NIH Grant/Contract Award Number )
390-02 ( Other Identifier: Mayo Clinic Cancer Center )
390-02 ( Other Identifier: Mayo Clinic IRB )
Not Provided
Not Provided
Not Provided
Steven E Schild, M.D., Mayo Clinic Cancer Center
Mayo Clinic
National Cancer Institute (NCI)
Study Chair: Steven E. Schild, M.D. Mayo Clinic
Mayo Clinic
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP