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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.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00653757
First received: April 4, 2008
Last updated: March 15, 2012
Last verified: March 2012
History of Changes
  Purpose

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: 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:

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Toxicity [ Designated as safety issue: Yes ]
  • Survival rates [ Designated as safety issue: Yes ]
  • Freedom from biochemical relapse rates [ Designated as safety issue: No ]
  • Local control rates [ Designated as safety issue: No ]
  • Distant failure rates [ Designated as safety issue: No ]
  • Biochemical freedom from failure rates [ Designated as safety issue: No ]
  • Comparison of outcomes to patients treated with conventional radiotherapy and intensity-modulated radiotherapy without radioimmunoguidance [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Obstructive urinary symptoms [ Designated as safety issue: No ]
  • Sexual health as assessed by inventory questionnaire [ Designated as safety issue: No ]

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:

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

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00653757

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

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Steven E Schild, M.D., Mayo Clinic Cancer Center
ClinicalTrials.gov Identifier: NCT00653757     History of Changes
Other Study ID Numbers: CDR0000588847, P30CA015083, 390-02, 390-02
Study First Received: April 4, 2008
Last Updated: March 15, 2012
Health Authority: United States: Federal Government

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
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Leuprolide
Goserelin
 Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 22, 2013