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

Mayo Clinic

Status and phase: Completed; Phase 2; Phase 1

Conditions: Prostate Cancer

Treatments: Radiation: intensity-modulated radiation therapy; Drug: goserelin acetate; Drug: leuprolide acetate; Radiation: image-guided radiation therapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00653757

P30CA015083 (U.S. NIH Grant/Contract)

390-02 (Other Identifier)

CDR0000588847

Details and patient eligibility

About

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.

Full 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

Enrollment: 100 estimated patients

Sex: Male

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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