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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

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Prostate Cancer
Intervention Radiation: SBRT Prostate
Enrollment 60
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Stereotactic Radiotherapy
Hide Arm/Group Description

Five fractions of 7.4 Gy each

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.

Period Title: Overall Study
Started 60
Completed 60
Not Completed 0
Arm/Group Title Stereotactic Radiotherapy
Hide Arm/Group Description

Five fractions of 7.4 Gy each

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.

Overall Number of Baseline Participants 60
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 60 participants
66
(49 to 82)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants
Female
0
   0.0%
Male
60
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
60
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants
American Indian or Alaska Native
1
   1.7%
Asian
1
   1.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
17
  28.3%
White
41
  68.3%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 60 participants
60
1.Primary Outcome
Title Number of Participants With Genitourinary Acute Toxicity
Hide Description Genitourinary Acute Toxicity is defined as Grade 3 or higher occurring within 90 days from the end of radiation treatment
Time Frame </= 90 days post radiation treatment, a total of 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Stereotactic Radiotherapy
Hide Arm/Group Description:

Five fractions of 7.4 Gy each

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.

Overall Number of Participants Analyzed 60
Measure Type: Count of Participants
Unit of Measure: Participants
Grade 1
44
  73.3%
Grade 2
15
  25.0%
Grade 3
0
   0.0%
Grade 4
0
   0.0%
Grade 5
0
   0.0%
2.Primary Outcome
Title Number of Participants With Genitourinary Late Toxicity
Hide Description Genitourinary Late Toxicity is defined as Grade 3 or higher occurring >90 days from the end of radiation treatment
Time Frame >90 days from the end of treatment, up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Stereotactic Radiotherapy
Hide Arm/Group Description:

Five fractions of 7.4 Gy each

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.

Overall Number of Participants Analyzed 60
Measure Type: Count of Participants
Unit of Measure: Participants
Grade 1
22
  36.7%
Grade 2
4
   6.7%
Grade 3
0
   0.0%
Grade 4
0
   0.0%
Grade 5
0
   0.0%
3.Primary Outcome
Title Number of Participants With Gastrointestinal Acute Toxicity
Hide Description Gastrointestinal Acute Toxicity is defined as Grade 3 or higher occurring within 90 days of the end of radiation treatment
Time Frame </= 90 days post radiation treatment, a total of 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Stereotactic Radiotherapy
Hide Arm/Group Description:

Five fractions of 7.4 Gy each

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.

Overall Number of Participants Analyzed 60
Measure Type: Count of Participants
Unit of Measure: Participants
Grade 1
19
  31.7%
Grade 2
3
   5.0%
Grade 3
0
   0.0%
Grade 4
0
   0.0%
Grade 5
0
   0.0%
4.Primary Outcome
Title Number of Participants With Gastrointestinal Late Toxicity
Hide Description Gastrointestinal Late Toxicity is defined as Grade 3 or higher occurring > 90 days from the end of radiation treatment
Time Frame >90 days from the end of treatment, up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Stereotactic Radiotherapy
Hide Arm/Group Description:

Five fractions of 7.4 Gy each

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.

Overall Number of Participants Analyzed 60
Measure Type: Count of Participants
Unit of Measure: Participants
Grade 1
15
  25.0%
Grade 2
5
   8.3%
Grade 3
1
   1.7%
Grade 4
0
   0.0%
Grade 5
0
   0.0%
5.Secondary Outcome
Title Disease Free Survival
Hide Description [Not Specified]
Time Frame 5 yrs
Hide Outcome Measure Data
Hide Analysis Population Description
Data not collected.
Arm/Group Title Stereotactic Radiotherapy
Hide Arm/Group Description:

Five fractions of 7.4 Gy each

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.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Quality of Life, as Measured by the Expanded Prostate Cancer Index Composite (EPIC-26) Short Form
Hide Description The EPIC-26 Short Form is a 13-item questionnaire. Scores range from 0-100, with higher scores representing better quality of life.
Time Frame 3 years post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Only participants who provided responses for each domain were analyzed.
Arm/Group Title Stereotactic Radiotherapy
Hide Arm/Group Description:

Five fractions of 7.4 Gy each

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.

Overall Number of Participants Analyzed 19
Mean (Standard Deviation)
Unit of Measure: score on a scale
Urinary Domain Number Analyzed 19 participants
94.1  (14.7)
Sexual Domain Number Analyzed 16 participants
77.7  (27.6)
Bowel Domain Number Analyzed 17 participants
90.2  (24.0)
Hormonal Domain Number Analyzed 17 participants
94.4  (8.6)
Time Frame 3 years
Adverse Event Reporting Description Only Genitourinary and Gastrointestinal adverse events were reported.
 
Arm/Group Title Stereotactic Radiotherapy
Hide Arm/Group Description

Five fractions of 7.4 Gy each

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.

All-Cause Mortality
Stereotactic Radiotherapy
Affected / at Risk (%)
Total   4/60 (6.67%)    
Hide Serious Adverse Events
Stereotactic Radiotherapy
Affected / at Risk (%) # Events
Total   1/60 (1.67%)    
Gastrointestinal disorders   
Proctitis  1 [1]  1/60 (1.67%)  1
1
Term from vocabulary, CTCAE v4.0
Indicates events were collected by systematic assessment
[1]
defined as Grade 3 or higher
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Stereotactic Radiotherapy
Affected / at Risk (%) # Events
Total   51/60 (85.00%)    
Gastrointestinal disorders   
Diarrhea  1  17/60 (28.33%)  17
Hemorrhoidal hemorrhage  1  4/60 (6.67%)  4
Proctitis  1  9/60 (15.00%)  9
Rectal hemorrhage  1  14/60 (23.33%)  14
Rectal pain  1  5/60 (8.33%)  5
Renal and urinary disorders   
Urinary frequency  1  51/60 (85.00%)  51
Urinary retention  1  30/60 (50.00%)  32
Urinary tract pain  1  22/60 (36.67%)  22
Urinary urgency  1  28/60 (46.67%)  29
1
Term from vocabulary, CTCAE v4.0
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Joan Cahill, BSN RN OCN CCRP
Organization: Assistant Research Practice Manager
Phone: (919) 668-5211
EMail: joan.cahill@duke.edu
Layout table for additonal information
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00941915    
Other Study ID Numbers: Pro00018266
First Submitted: July 17, 2009
First Posted: July 20, 2009
Results First Submitted: June 22, 2021
Results First Posted: January 24, 2022
Last Update Posted: January 24, 2022