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Phase I/II Study of Radioimmunoguided Intensity Modulated Radiotherapy (IMRT) for Prostate Cancer


Phase 1/Phase 2
19 Years
N/A
Not Enrolling
Male
Prostate Cancer

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Trial Information

Phase I/II Study of Radioimmunoguided Intensity Modulated Radiotherapy (IMRT) for 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

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Toxicity

Safety Issue:

Yes

Principal Investigator

Steven E. Schild, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000588847

NCT ID:

NCT00653757

Start Date:

March 2002

Completion Date:

December 2007

Related Keywords:

  • Prostate Cancer
  • stage I prostate cancer
  • stage II prostate cancer
  • stage III prostate cancer
  • stage IV prostate cancer
  • Prostatic Neoplasms

Name

Location

Mayo Clinic in ArizonaScottsdale, Arizona  85259-5404