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

Sponsors and Collaborators:	Mayo Clinic Scottsdale National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00653757

Purpose

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.

Condition	Intervention	Phase
Prostate Cancer	Drug: goserelin Drug: leuprolide acetate Radiation: image-guided radiation therapy Radiation: intensity-modulated radiation therapy	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	Phase I/II Study of Radioimmunoguided Intensity Modulated Radiotherapy (IMRT) for Prostate Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer Radiation Therapy

Drug Information available for: Leuprolide Goserelin Leuprolide acetate

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

Obstructive urinary symptoms [ Designated as safety issue: No ]
Sexual health as assessed by inventory questionnaire [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	March 2002
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Detailed 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

Eligibility

Ages Eligible for Study:	19 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00653757

Sponsors and Collaborators

Mayo Clinic Scottsdale

National Cancer Institute (NCI)

Investigators

Study Chair:	Steven E. Schild, MD	Mayo Clinic Scottsdale
Investigator:	William W. Wong, MD	Mayo Clinic Scottsdale
Investigator:	Sujay Vora, MD	Mayo Clinic Scottsdale
Investigator:	Michael Roarke, MD	Mayo Clinic Scottsdale
Investigator:	Gary Ezzell, PhD	Mayo Clinic Scottsdale

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000588847, MAYO-39002
Study First Received:	April 4, 2008
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00653757 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage I prostate cancer
stage II prostate cancer
stage III prostate cancer
stage IV prostate cancer

Study placed in the following topic categories:

Antineoplastic Agents, Hormonal
Prostatic Diseases
Genital Neoplasms, Male
Leuprolide

Goserelin
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:

Genital Neoplasms, Male
Prostatic Diseases
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Physiological Effects of Drugs
Urogenital Neoplasms
Reproductive Control Agents
Genital Diseases, Male

Pharmacologic Actions
Neoplasms
Neoplasms by Site
Leuprolide
Therapeutic Uses
Fertility Agents, Female
Fertility Agents
Prostatic Neoplasms

ClinicalTrials.gov processed this record on September 10, 2009