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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00653757
• Other study ID #: CDR0000588847
• Secondary ID: P30CA015083390-0
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: April 4, 2008
• Last updated: March 15, 2012
• Start date: March 2002
• Est. completion date: December 2007

Study information

• Verified date: March 2012
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2007
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 19 Years and older

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• goserelin acetate

• leuprolide acetate

Radiation:
• image-guided radiation therapy

• intensity-modulated radiation therapy

Locations

Country	Name	City	State
United States	Mayo Clinic in Arizona	Scottsdale	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Toxicity			Yes
Primary	Survival rates			Yes
Primary	Freedom from biochemical relapse rates			No
Primary	Local control rates			No
Primary	Distant failure rates			No
Primary	Biochemical freedom from failure rates			No
Primary	Comparison of outcomes to patients treated with conventional radiotherapy and intensity-modulated radiotherapy without radioimmunoguidance			No
Secondary	Obstructive urinary symptoms			No
Secondary	Sexual health as assessed by inventory questionnaire			No