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Stereotactic Radiation Therapy in Treating Patients With Prostate Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00619515
First received: February 20, 2008
Last updated: February 27, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention
Prostate Cancer
Other: questionnaire administration
Procedure: implanted fiducial-based imaging
Radiation: stereotactic radiosurgery

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Evaluation of Cyberknife Stereotactic Radiosurgery for Low and Low/Intermediate Risk Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Case Comprehensive Cancer Center:

Primary Outcome Measures:
  • Rate of acute toxicities as assessed by NCI CTCAE v3.0 [ Time Frame: Within 90 days of completing treatment ] [ Designated as safety issue: Yes ]
    This study's primary goal is to determine the rate of acute grade 3-5 toxicities following CyberKnife treatment. Per RTOG/ECOG, acute toxicity will be defined as occurring within 90 days of completing treatment.


Secondary Outcome Measures:
  • Rate of late grade 3-5 toxicities as assessed by NCI CTCAE v3.0 [ Time Frame: Within 5 years of completing treatment ] [ Designated as safety issue: Yes ]
    Late toxicity will be defined as toxicity occurring more than 90 days after treatment. It is graded based on Common Terminology Criteria for Adverse Events (CTCAE) v3.0, and RTOG/ECOG definitions.

  • Biochemical disease-free survival [ Time Frame: Assessed at months 3,6,12,18,24 and every 6 months through 5 years ] [ Designated as safety issue: No ]
  • Disease-free survival (Phoenix and ASTRO definitions) [ Time Frame: Assessed yearly for 5 years ] [ Designated as safety issue: No ]
  • Disease-specific survival [ Time Frame: Assessed yearly for 5 years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Assessed yearly for 5 years ] [ Designated as safety issue: No ]
  • Rate of local failure [ Time Frame: Assessed at months 3,6,12,18,24 and every 12 months through 5 years ] [ Designated as safety issue: No ]
  • Rate of distant failure [ Time Frame: Assessed at months 3,6,12,18,24 and every 12 months through 5 years ] [ 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 [ Time Frame: Survery at 1,6,12 months and yearly up to 5 years ] [ Designated as safety issue: No ]

Enrollment: 73
Study Start Date: December 2007
Study Completion Date: February 2013
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CyberKnife® stereotactic radiosurgery Other: questionnaire administration
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).
Procedure: implanted fiducial-based imaging
Undergo fiducial placement imaging
Radiation: stereotactic radiosurgery
Patients undergo fiducial placement using ultrasound. At least 5-10 days later, patients undergo CyberKnife® stereotactic radiosurgery once daily for 5 days.

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.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00619515

Locations
United States, Ohio
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065
UHHS Chagrin Highlands Medical Center
Cleveland, Ohio, United States, 44122
University Suburban Health Center
Cleveland, Ohio, United States, 44121
UH-Westlake
Westlake, Ohio, United States, 44145
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
Study Chair: Lee E. Ponsky, MD Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00619515     History of Changes
Other Study ID Numbers: CASE13807, P30CA043703, CASE13807
Study First Received: February 20, 2008
Last Updated: February 27, 2013
Health Authority: United States: Federal Government

Keywords provided by Case Comprehensive Cancer Center:
adenocarcinoma of the prostate
stage I prostate cancer
stage II prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on November 20, 2014