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Stereotactic Body Radiotherapy (SBRT) for Prostate Cancer (SMART)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00941915
Recruitment Status : Completed
First Posted : July 20, 2009
Results First Posted : January 24, 2022
Last Update Posted : January 24, 2022
Sponsor:
Information provided by (Responsible Party):
Duke University

Tracking Information
First Submitted Date  ICMJE July 17, 2009
First Posted Date  ICMJE July 20, 2009
Results First Submitted Date  ICMJE June 22, 2021
Results First Posted Date  ICMJE January 24, 2022
Last Update Posted Date January 24, 2022
Actual Study Start Date  ICMJE November 9, 2009
Actual Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 17, 2021)
  • Number of Participants With Genitourinary Acute Toxicity [ Time Frame: </= 90 days post radiation treatment, a total of 90 days ]
    Genitourinary Acute Toxicity is defined as Grade 3 or higher occurring within 90 days from the end of radiation treatment
  • Number of Participants With Genitourinary Late Toxicity [ Time Frame: >90 days from the end of treatment, up to 3 years ]
    Genitourinary Late Toxicity is defined as Grade 3 or higher occurring >90 days from the end of radiation treatment
  • Number of Participants With Gastrointestinal Acute Toxicity [ Time Frame: </= 90 days post radiation treatment, a total of 90 days ]
    Gastrointestinal Acute Toxicity is defined as Grade 3 or higher occurring within 90 days of the end of radiation treatment
  • Number of Participants With Gastrointestinal Late Toxicity [ Time Frame: >90 days from the end of treatment, up to 3 years ]
    Gastrointestinal Late Toxicity is defined as Grade 3 or higher occurring > 90 days from the end of radiation treatment
Original Primary Outcome Measures  ICMJE
 (submitted: July 17, 2009)
Toxicity [ Time Frame: 3 years ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 17, 2021)
  • Disease Free Survival [ Time Frame: 5 yrs ]
  • Quality of Life, as Measured by the Expanded Prostate Cancer Index Composite (EPIC-26) Short Form [ Time Frame: 3 years post-treatment ]
    The EPIC-26 Short Form is a 13-item questionnaire. Scores range from 0-100, with higher scores representing better quality of life.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 17, 2009)
  • Disease free survival [ Time Frame: 5 yrs ]
  • Quality of Life [ Time Frame: 3 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Stereotactic Body Radiotherapy (SBRT) for Prostate Cancer
Official Title  ICMJE A Phase II Study of Stereotactic Body Radiotherapy (SBRT) for Prostate Cancer Using Continuous Real-time Evaluation of Prostate Motion and IMRT Plan Reoptimization Based on the Anatomy of the Day
Brief Summary The purpose of this study is to evaluate the incidence of urinary and gastrointestinal acute and late side effects in patients treated with stereotactic body radiotherapy (SBRT) to the prostate. Stereotactic radiation therapy is given as five treatments over a 2-3 week period. The prostate is localized and the plan is reoptimized as needed prior to each treatment.
Detailed Description This protocol requires radiation treatments to be performed with a stereotactic technique with the use of a 3-D coordinate system defined by implanted transponders (i.e. Calypso) or use of the ExacTrac system and/or use cone-beam CT (CBCT) with fiducial markers.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE Radiation: SBRT Prostate
Five fractions of 7.4 Gy. The total dose will be 37 Gy. A minimum of 36 hours and a maximum of 96 hours should separate each treatment. No more than 3 fractions will be delivered per week. The total duration of treatment will be no shorter than 10 days and no longer than 18 days.
Other Names:
  • Stereotactic body radiation therapy
  • External beam radiation therapy
Study Arms  ICMJE Experimental: Stereotactic Radiotherapy
Five fractions of 7.4 Gy each
Intervention: Radiation: SBRT Prostate
Publications *

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: July 17, 2009)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 17, 2020
Actual Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically confirmed diagnosis of adenocarcinoma of the prostate within 365 days of study enrollment
  • History/physical examination with digital rectal examination of the prostate within 8 weeks prior to study enrollment
  • Gleason score less than or equal to 7
  • Clinical Stage T1-T2c
  • PSA
  • less than or = 15 ng/ml prior to start of therapy if Gleason < or = 6 or
  • less than or = 10 ng/ml prior to start of therapy if Gleason = 7
  • Zubrod Performance Status 0-1
  • Age > 40

Exclusion Criteria:

  • Prior or concurrent invasive malignancy (except non-melanomatous skin cancer) or lymphomatous/hematogenous malignancy unless continually disease free for a minimum of 5 years. (Carcinoma in situ of the bladder or oral cavity is permissible)
  • Evidence of distant metastases
  • Regional lymph node involvement
  • Significant urinary obstruction
  • Estimated prostate gland > 100 grams
  • Previous radical surgery (prostatectomy) or cryosurgery for prostate cancer
  • Previous pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy
  • Previous hormonal therapy, such as LHRH agonists (e.g. goserelin, leuprolide), anti-androgens (e.g., flutamide, bicalutamide), estrogens (e.g., DES), or surgical castration (bilateral orchiectomy) or planned concurrent androgen deprivation therapy
  • Previous or concurrent cytotoxic chemotherapy for prostate cancer
  • Prosthetic implants in the pelvic region that contain metal or conductive materials (e.g., an artificial hip).
  • Severe, active comorbidity
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 40 Years to 82 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00941915
Other Study ID Numbers  ICMJE Pro00018266
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Duke University
Original Responsible Party Willliam Robert Lee, MD, Duke University Medical Center, Dept of Radiation Oncology
Current Study Sponsor  ICMJE Duke University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: William R Lee, MD Duke University
PRS Account Duke University
Verification Date November 2021

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