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Hypofractionated SBRT For Prostate Cancer

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ClinicalTrials.gov Identifier: NCT00977860
Recruitment Status : Recruiting
First Posted : September 16, 2009
Last Update Posted : December 5, 2018
Sponsor:
Information provided by (Responsible Party):
Dwight Heron, University of Pittsburgh

Tracking Information
First Submitted Date  ICMJE September 15, 2009
First Posted Date  ICMJE September 16, 2009
Last Update Posted Date December 5, 2018
Study Start Date  ICMJE October 2010
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 15, 2009)
  • To determine, in both low-risk and intermediate-risk cohorts, the rates of acute and late grade 3 or higher GI and GU toxicity observed during a 24 month follow up [ Time Frame: 24 months ]
  • To estimate the rate of biochemical Disease-Free Survival [ Time Frame: 24 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00977860 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 15, 2009)
To determine the rate of local failure, the rate of distant failure, the overall survival, the quality of life in generic and organ-specific domains [ Time Frame: 24 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 15, 2009)
  • To determine the rate of local failure [ Time Frame: 24 months ]
  • To determine the rate of distant failure [ Time Frame: 24 months ]
  • To determine the rate of disease-free survival [ Time Frame: 24 months ]
  • To determine the rate of disease-specific survival [ Time Frame: 24 months ]
  • To determine the overall survival [ Time Frame: 24 months ]
  • To determine the quality of life (QOL) in generic and organ-specific domains [ Time Frame: 24 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hypofractionated SBRT For Prostate Cancer
Official Title  ICMJE Prospective Evaluation Of Hypofractionated Stereotactic Body Radiotherapy For Low And Intermediate Risk Prostate Cancer
Brief Summary The purpose of this study is to determine, in both low-risk and intermediate-risk cohorts, the rates of acute and late grade 3 or higher gastrointestinal and genitourinary toxicity observed during a 24 month follow up and to estimate the rate of biochemical Disease-Free Survival, Phoenix and American Society for Therapeutic Radiology and Oncology definitions, at 2 years following hypofractionated stereotactic body radiation therapy for low and intermediate risk prostate cancer.
Detailed Description

Radiosurgery should be ideal for treating prostate cancer because:

  • targeting accuracy for static targets is excellent, with an error of about 1mm,
  • it can adjust for intra-fractional organ motion, reducing the volume of the target PTV and therefore the dose to surrounding organs,
  • by using over one-hundred non-conplanar beams, the dose gradient between the prostate and surrounding tissues may be superior to that achieved with conventional linear accelerators,
  • the radiobiology of prostate cancer may favor large dose per fractions.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE Radiation: Stereotactic Body Radiation Therapy
36.25 Gy in 5 fractions (7.25 Gy/fx) delivered over a 2-week period
Other Names:
  • CyberKnife
  • Trilogy
  • True Beam
  • Radiosurgery
Study Arms  ICMJE SBRT
Intervention: Radiation: Stereotactic Body Radiation Therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 15, 2009)
111
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2023
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically proven prostate adenocarcinoma
  • Gleason score 2-7
  • Biopsy within one year of date of registration
  • Clinical stage T1b-T2b, N0-Nx, M0-Mx (AJCC 6th Edition)
  • T-stage and N-stage determined by physical exam and available imaging studies (ultrasound, CT, and/or MRI)
  • M-stage determined by physical exam, CT or MRI. Bone scan not required unless clinical findings suggest possible osseous metastases.
  • PSA ≤ 20 ng/dL
  • Patients belonging in one of the following risk groups:
  • Low: CS T1b-T2a and Gleason 2-6 and PSA ≤ 10, or
  • Intermediate: CS T2b and Gleason 2-6 and PSA ≤ 10, or CS T1b-T2b, and Gleason 2-6 and PSA ≤ 20 ng/dL, or Gleason 7 and PSA ≤ 10 ng/dL
  • Prostate volume: ≤ 100 cc
  • Determined using: volume = π/6 x length x height x width
  • Measurement from CT or ultrasound ≤90 days prior to registration.
  • ECOG performance status 0-1
  • Completion of patient questionnaires:FACT-G questionnaire, AUA questionnaire, EPIC-26 questionnaire, SHIM questionnaire, Utilization of Sexual Medications/Devices questionnaire
  • Consent signed.

Exclusion Criteria:

  • Prior prostatectomy or cryotherapy of the prostate
  • Prior radiotherapy to the prostate or lower pelvis
  • Implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery, in the investigator's opinion.
  • Chemotherapy for a malignancy in the last 5 years.
  • History of an invasive malignancy (other than this prostate cancer, or basal or squamous skin cancers) in the last 5 years.
  • Hormone ablation for two months prior to enrollment, or during treat
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Dwight E Heron, MD 412-623-6720 herond2@upmc.edu
Contact: Karen D Holeva 412-623-1275 holevakd@upmc.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00977860
Other Study ID Numbers  ICMJE 09-031
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dwight Heron, University of Pittsburgh
Study Sponsor  ICMJE University of Pittsburgh
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dwight E Heron, MD University of Pittsburgh
Principal Investigator: Rodney E Wegner, MD University of Pittsburgh
PRS Account University of Pittsburgh
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP