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Stereotactic Radiation Therapy in Treating Patients With Prostate Cancer

This study is currently recruiting participants.
Information provided by National Cancer Institute (NCI)

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Descriptive Information Fields
Brief Title  Stereotactic Radiation Therapy in Treating Patients With Prostate Cancer
Official Title  Prospective Evaluation of Cyberknife Stereotactic Radiosurgery for Low and Low/Intermediate Risk Prostate Cancer
Brief Summary

RATIONALE: Stereotactic radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue.

PURPOSE: This trial is studying the side effects of stereotactic radiation therapy and to see how well it works in treating patients with prostate cancer.

Detailed Description

OBJECTIVES:

Primary

  • To estimate in both low- and low-to-intermediate-risk groups of patients with prostate cancer, the rate of acute toxicities observed during the 5 years following CyberKnife® stereotactic radiosurgery (SRS).

Secondary

  • To estimate the rate of late grade 3-5 toxicities after SRS in these patients.
  • To measure biochemical disease-free survival of patients treated with this therapy.
  • To measure rates of local failure, distant failure, disease-free survival, disease-specific survival, and overall survival of patients treated with this therapy.
  • To measure quality of life in generic and organ-specific domains in patients treated with this therapy.
  • To evaluate imaging modalities and their potential role in the detection of prostate cancer persistence, recurrence, and/or progression in patients treated with this therapy.

OUTLINE: Patients are stratified according to risk group (low risk vs low/intermediate risk).

Patients undergo fiducial placement using ultrasound. At least 5-10 days later, patients undergo CyberKnife® stereotactic radiosurgery once daily for 5 days.

Patients complete 4 questionnaires at baseline and periodically during study to assess acute and late toxicities and quality of life (e.g., overall health status, patient function, sexual function, and urinary symptoms).

After completion of study therapy, patients are followed for up to 5 years.

Study Phase
Study Type  Interventional
Study Design  Treatment
Primary Outcome Measure  Rate of acute toxicities as assessed by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]
Secondary Outcome Measure  Rate of late grade 3-5 toxicities as assessed by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]
Biochemical disease-free survival [ Designated as safety issue: No ]
Disease-free survival (Phoenix and ASTRO definitions) [ Designated as safety issue: No ]
Disease-specific survival [ Designated as safety issue: No ]
Overall survival [ Designated as safety issue: No ]
Rate of local failure [ Designated as safety issue: No ]
Rate of distant failure [ Designated as safety issue: No ]
Quality of life as measured by the Short Form-12 Health Survey, Expanded Prostate Cancer Index Composite, and the American Urological Association Symptom Index, and the Utilization of Sexual Medications/Devices [ Designated as safety issue: No ]
Condition  Prostate Cancer
Intervention  Procedure: quality-of-life assessment
Procedure: questionnaire administration
Procedure: stereotactic radiosurgery
MEDLINE PMIDs
Links Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  102
Start Date  December 2007
Completion Date
Eligibility Criteria 

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the prostate

    • Disease confirmed by biopsy within 1 year of study entry
    • Gleason score 2-7(3+4)
    • Clinical stage T1a or T2b, N0 or NX, M0 or MX

      • T- stage and N-stage determined by physical exam and available imaging studies (i.e., ultrasound, CT scan, and/or MRI)
      • M-stage determined by physical exam, CT scan, and/or MRI

        • Bone scan is not required unless clinical findings suggest possible osseous metastases
  • PSA ≤ 10 ng/mL within the past 60 days
  • At risk for recurrence, as defined by 1 of the following risk groups:

    • Low-risk, defined by the following combination:

      • Stage T1a-T2a, Gleason 2-6, and PSA ≤ 10 ng/mL
    • Low- to-Intermediate-risk, defined by either of the following combinations:

      • Stage T2b, Gleason 2-6, and PSA ≤ 10 ng/mL
      • Stage T2b, Gleason 3+4=7, and PSA ≤ 10 ng/mL
  • Prostate volume must be ≤ 100 cc

    • Determined by measurement from CT scan or ultrasound within the past 90 days or within the past 14 days if hormone therapy is given

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-1
  • No implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery, in the investigator's opinion

PRIOR CONCURRENT THERAPY:

  • No prior definitive therapy for prostate cancer, including prostatectomy, cryotherapy, or radiotherapy to the prostate or lower pelvis
  • No more than 6 months of hormone ablation for gland downsizing
Gender Male
Ages
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00619515
Organization ID CDR0000583273
Secondary IDs †† CASE-13807
Study Sponsor  Case Comprehensive Cancer Center
Collaborators †† National Cancer Institute (NCI)
Investigators 
Study Chair:     Lee E. Ponsky, MD     Case Comprehensive Cancer Center    
Investigator:     Douglas Einstein, MD, PhD     Case Comprehensive Cancer Center    
Information Provided By National Cancer Institute (NCI)
Verification Date May 2008
First Received Date  February 20, 2008
Last Updated Date July 23, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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