Skip to main content
OpenTrials
Completed

NCT Number: NCT00653757

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

19 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Mayo Clinic in Arizona

Scottsdale, Arizona, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Goserelin acetate

Drug

Leuprolide Acetate

Drug

image-guided radiation therapy

Radiation

Intensity-Modulated Radiation Therapy

Radiation

Primary outcomes

  1. Toxicity

  2. Survival rates

  3. Freedom from biochemical relapse rates

  4. Local control rates

  5. Distant failure rates

  6. Biochemical freedom from failure rates

  7. Comparison of outcomes to patients treated with conventional radiotherapy and intensity-modulated radiotherapy without radioimmunoguidance

Secondary outcomes

  1. Obstructive urinary symptoms

  2. Sexual health as assessed by inventory questionnaire

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2002
Primary completion
2006
Study completion
2007
First posted
Apr 7, 2008
Registry last updated
Mar 19, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.