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

This study is currently recruiting participants.
Verified April 2013 by Duke University
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00941915
First received: July 17, 2009
Last updated: April 15, 2013
Last verified: April 2013
History of Changes
  Purpose

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 Phase
Prostate Cancer
 Radiation: SBRT Prostate
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
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:

U.S. FDA Resources

Further study details as provided by Duke University:

Primary Outcome Measures:
  • Toxicity [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Disease free survival [ Time Frame: 5 yrs ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: November 2009
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (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.

  Eligibility

Ages Eligible for Study:   40 Years to 82 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00941915

Contacts
Contact: William R Lee, MD, MPH 919 668-5640 w.robert.lee@duke.edu
Contact: Joan Cahill, MSA 919 668-3726 joan.cahill@duke.edu

Locations
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: William R Lee, MD     919-668-5640     w.robert.lee@duke.edu    
Contact: Paula Kennedy-Newton, BScN     919 668-3726     paula.kennedy@duke.edu    
Principal Investigator: W. Robert Lee, MD, MPH            
Sub-Investigator: Jackie Wu, PhD            
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: William R Lee, MD Duke University
  More Information

Publications:

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00941915     History of Changes
Other Study ID Numbers: Pro00018266
Study First Received: July 17, 2009
Last Updated: April 15, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
CaP
SBRT
Prostate
ExacTrac
Calypso
 IMRT
Radiation
Cancer of Prostate
Prostatic Neoplasms

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

ClinicalTrials.gov processed this record on May 22, 2013