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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Duke University Identifier:
First received: July 17, 2009
Last updated: February 28, 2017
Last verified: January 2017
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.

Condition Intervention
Prostate Cancer
Radiation: SBRT Prostate

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Duke University:

Primary Outcome Measures:
  • Toxicity [ Time Frame: 3 years ]

Secondary Outcome Measures:
  • Disease free survival [ Time Frame: 5 yrs ]
  • Quality of Life [ Time Frame: 3 years ]

Estimated Enrollment: 60
Study Start Date: November 2009
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stereotactic Radiotherapy
Five fractions of 7.4 Gy each
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

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.

Ages Eligible for Study:   40 Years to 82 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00941915

United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Principal Investigator: William R Lee, MD Duke University
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Duke University Identifier: NCT00941915     History of Changes
Other Study ID Numbers: Pro00018266
Study First Received: July 17, 2009
Last Updated: February 28, 2017

Keywords provided by Duke University:
Cancer of Prostate
Prostatic Neoplasms

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases processed this record on April 28, 2017