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Stereotactic Ablative Radiotherapy (SABR) for Low Risk Prostate Cancer With Injectable Rectal Spacer

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: NCT02353832
Recruitment Status : Completed
First Posted : February 3, 2015
Results First Posted : May 7, 2019
Last Update Posted : November 3, 2021
Sponsor:
Information provided by (Responsible Party):
Michael Folkert, University of Texas Southwestern Medical Center

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Prostate Cancer
Intervention Device: Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent)
Enrollment 44
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Single Arm: Injectable Rectal Spacer
Hide Arm/Group Description Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent): Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent PEG based product)
Period Title: Overall Study
Started 44
Completed 44
Not Completed 0
Arm/Group Title Single Arm: Injectable Rectal Spacer
Hide Arm/Group Description Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent): Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent PEG based product
Overall Number of Baseline Participants 44
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants
<=18 years
0
   0.0%
Between 18 and 65 years
27
  61.4%
>=65 years
17
  38.6%
Age, Continuous  
Mean (Full Range)
Unit of measure:  YEARS
Number Analyzed 44 participants
70
(50 to 89)
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants
Female
0
   0.0%
Male
44
 100.0%
[1]
Measure Description: Male only study
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
41
  93.2%
Unknown or Not Reported
3
   6.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
1
   2.3%
Black or African American
8
  18.2%
White
33
  75.0%
More than one race
0
   0.0%
Unknown or Not Reported
2
   4.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 44 participants
44
1.Primary Outcome
Title Percentage of Participants With Reduction in Acute Per-prostatic Rectal Ulcer Events Events From 90%+ to <70% (Particularly in the Anterior Rectum)
Hide Description The effectiveness of rectal spacer use was measured to determine if they are effective at improving protection of rectum from high dose radiation, using rate of rectal ulceration as a surrogate measure of acute effects
Time Frame Median 9 months within the end of radiation treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Observed ulceration rate
Arm/Group Title Single Arm: Injectable Rectal Spacer
Hide Arm/Group Description:
Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent): Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent PEG based product)
Overall Number of Participants Analyzed 44
Measure Type: Number
Unit of Measure: percentage of participants
13.6
2.Primary Outcome
Title Effectiveness of Space Creation of >= 7.5 mm in Protecting Rectum From Toxicity
Hide Description The effectiveness of rectal spacer use was measured to determine if they are effective at improving protection of rectum from high dose radiation, using rate of rectal ulceration as a surrogate measure of acute effects
Time Frame Median 9 months within the end of radiation treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Single Arm: Injectable Rectal Spacer
Hide Arm/Group Description:
Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent): Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent PEG based product)
Overall Number of Participants Analyzed 44
Median (Full Range)
Unit of Measure: mm
11.5
(6.6 to 21.1)
3.Secondary Outcome
Title Spacer Related Acute Toxicity
Hide Description Assess for spacer related acute toxicity. Spacer related toxicity could be related to the procedure itself (bleeding, infection, pain), or secondary effects of spacer (erectile dysfunction, persistent pain and discomfort).
Time Frame 5 years
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Spacer Stability by Dimensions
Hide Description Determine spacer's stability during course of therapy and to ensure that it is stable enough to reliably use for high dose SABR treatments (using cone beam CTs done during each treatments to measure spacer dimensions).
Time Frame 1 month
Outcome Measure Data Not Reported
Time Frame Assessed at 1.5, 3,6, and 9 months post-treatment by direct anoscopy by the treating radiation oncologist
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Single Arm: Injectable Rectal Spacer
Hide Arm/Group Description Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent): Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent PEG based product)
All-Cause Mortality
Single Arm: Injectable Rectal Spacer
Affected / at Risk (%)
Total   0/44 (0.00%) 
Hide Serious Adverse Events
Single Arm: Injectable Rectal Spacer
Affected / at Risk (%)
Total   0/44 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Single Arm: Injectable Rectal Spacer
Affected / at Risk (%)
Total   20/44 (45.45%) 
Gastrointestinal disorders   
Abdominal Pain * 1  2/44 (4.55%) 
Anal Pain * 1  5/44 (11.36%) 
Anorexia  1 [1]  10/44 (22.73%) 
Constipation * 1  13/44 (29.55%) 
Diarrhea * 1  10/44 (22.73%) 
Fecal Incontinence * 1  4/44 (9.09%) 
Flatulence * 1  10/44 (22.73%) 
Bowel Frequency * 1  10/44 (22.73%) 
Bowel Urgency * 1  7/44 (15.91%) 
Tenesmus * 1  10/44 (22.73%) 
Gastrointestinal Pain * 1  10/44 (22.73%) 
Hemorrhoidal Hemorrhage * 1  10/44 (22.73%) 
Hemorrhoids * 1  4/44 (9.09%) 
Pelvic Pain * 1  10/44 (22.73%) 
Perineal Pain * 1  10/44 (22.73%) 
Proctitis * 1  16/44 (36.36%) 
Rectal Hemorrhage * 1  10/44 (22.73%) 
Rectal Pain * 1  13/44 (29.55%) 
Rectal Ulcer * 1  7/44 (15.91%) 
Telangiectasia * 1  10/44 (22.73%) 
General disorders   
Anxiety * 1  10/44 (22.73%) 
Fatigue * 1  7/44 (15.91%) 
Fever  1  10/44 (22.73%) 
Paresthesia * 1  10/44 (22.73%) 
Weight Gain * 1  10/44 (22.73%) 
Renal and urinary disorders   
Bladder Spasm * 1 [2]  10/44 (22.73%) 
Cystitis Noninfective * 1 [2]  8/44 (18.18%) 
Genital Edema * 1 [2]  10/44 (22.73%) 
Hematuria * 1 [2]  4/44 (9.09%) 
Infection, Site of Spacer * 1 [2]  14/44 (31.82%) 
Prostatic Infection * 1 [2]  2/44 (4.55%) 
Prostatic Obstruction * 1 [2]  2/44 (4.55%) 
Dysuria * 1 [2]  10/44 (22.73%) 
Urinary Tract Infection * 1 [2]  10/44 (22.73%) 
Weak Urine Stream * 1 [2]  15/44 (34.09%) 
Scrotal Pain * 1 [2]  10/44 (22.73%) 
Urinary Frequency * 1 [2]  10/44 (22.73%) 
Urinary Incontinence * 1 [2]  14/44 (31.82%) 
Urinary Obstruction * 1 [2]  2/44 (4.55%) 
Urinary Retention * 1 [2]  13/44 (29.55%) 
Urinary Tract Pain * 1 [2]  3/44 (6.82%) 
Urinary Urgency * 1 [2]  14/44 (31.82%) 
Decreased Libido * 1 [3]  3/44 (6.82%) 
Reproductive system and breast disorders   
Ejaculation Disorder * 1 [3]  5/44 (11.36%) 
Erectile Dysfunction * 1 [3]  4/44 (9.09%) 
Blood in Semen * 1 [3]  10/44 (22.73%) 
Skin and subcutaneous tissue disorders   
Rash Acneiform * 1  10/44 (22.73%) 
1
Term from vocabulary, CTCAE (4.0)
*
Indicates events were collected by non-systematic assessment
Indicates events were collected by systematic assessment
[1]
Loss of Appetite
[2]
Non-Sexual Domain
[3]
Sexual Domain
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Michael Folkert, M.D., Ph.D.
Organization: University of Texas Southwestern
Phone: 214-645-8525
EMail: Michael.Folkert@utsouthwestern.edu
Layout table for additonal information
Responsible Party: Michael Folkert, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT02353832    
Other Study ID Numbers: STU 092013-013
First Submitted: January 16, 2015
First Posted: February 3, 2015
Results First Submitted: January 18, 2019
Results First Posted: May 7, 2019
Last Update Posted: November 3, 2021