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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

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 Intervention Phase
Prostate Cancer Drug: goserelin acetate Drug: leuprolide acetate Radiation: image-guided radiation therapy Radiation: intensity-modulated radiation therapy Phase 1 Phase 2

Study Type: Interventional
Study Design: Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/II Study of Radioimmunoguided Intensity Modulated Radiotherapy (IMRT) for Prostate Cancer

Resource links provided by NLM:

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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

Secondary Outcome Measures:
  • Obstructive urinary symptoms
  • Sexual health as assessed by inventory questionnaire

Estimated Enrollment: 100
Study Start Date: March 2002
Study Completion Date: December 2007
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Detailed Description:


  • 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


Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No


  • 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00653757

United States, Arizona
Mayo Clinic in Arizona
Scottsdale, Arizona, United States
Sponsors and Collaborators
Mayo Clinic
National Cancer Institute (NCI)
Study Chair: Steven E. Schild, M.D. Mayo Clinic
  More Information

Responsible Party: Steven E Schild, M.D., Mayo Clinic Cancer Center Identifier: NCT00653757     History of Changes
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 )
Study First Received: April 4, 2008
Last Updated: March 15, 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:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents processed this record on September 21, 2017