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:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00653757
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 [ 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 ]
Same as current
Complete list of historical versions of study NCT00653757 on ClinicalTrials.gov Archive Site
  • Obstructive urinary symptoms [ Designated as safety issue: No ]
  • Sexual health as assessed by inventory questionnaire [ Designated as safety issue: No ]
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.

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

Interventional
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
December 2007
December 2006   (final data collection date for primary outcome measure)

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
Male
19 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00653757
CDR0000588847, P30CA015083, 390-02, 390-02
Yes
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