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Endoscopic Evaluation of Late Rectal Injury Following CyberKnife Radiosurgery for Prostate Cancer

This study has been terminated.
(The study only accrued 4 patients in 2 years, far below target (40). It was closed with no subject reached the primary endpoint, thus no results to publish.)
Sponsor:
Information provided by (Responsible Party):
Sean Collins, M.D., PhD, Georgetown University
ClinicalTrials.gov Identifier:
NCT01618838
First received: June 12, 2012
Last updated: March 21, 2014
Last verified: March 2014
Results First Received: March 21, 2014  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Stage II Prostate Carcinoma
Intervention: Radiation: CyberKnife radiosurgery

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
CyberKnife Radiosurgery, Colonoscopy

CyberKnife radiosurgery for prostate cancer; bowel toxicity will be evaluated at 2 years by colonoscopy (lower endoscopy).

CyberKnife radiosurgery: Treatment Planning:

Inverse planning using the CyberKnife planning system will be employed. The treatment plan used for each treatment will be based on an analysis of the volumetric dose including dose-volume histogram (DVH) analyses of the PTV and critical normal structures. The homogeneous CT model shall be used. Number of paths and beams used for each patient will vary and will be determined by the selected individual treatment plan. To reduce overall treatment time and total monitor units, 150-200 non-zero beams are recommended. No more than 250 beams shall be employed. Tuning structures shall be employed to minimize conformality index (CI) and new conformality index (nCI), preferably yielding values less than 1.20 and 1.25, respectively.


Participant Flow:   Overall Study
    CyberKnife Radiosurgery, Colonoscopy  
STARTED     4  
COMPLETED     0  
NOT COMPLETED     4  
slow accrual, trial closed prematurely.                 4  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Age: median 75.5 y/o Race: 2 Blacks, 1 Caucasian and 1 Asian

Reporting Groups
  Description
CyberKnife Radiosurgery, Colonoscopy

CyberKnife radiosurgery for prostate cancer; bowel toxicity will be evaluated at 2 years by colonoscopy (lower endoscopy).

CyberKnife radiosurgery: Treatment Planning:

Inverse planning using the CyberKnife planning system will be employed. The treatment plan used for each treatment will be based on an analysis of the volumetric dose including dose-volume histogram (DVH) analyses of the PTV and critical normal structures. The homogeneous CT model shall be used. Number of paths and beams used for each patient will vary and will be determined by the selected individual treatment plan. To reduce overall treatment time and total monitor units, 150-200 non-zero beams are recommended. No more than 250 beams shall be employed. Tuning structures shall be employed to minimize conformality index (CI) and new conformality index (nCI), preferably yielding values less than 1.20 and 1.25, respectively.


Baseline Measures
    CyberKnife Radiosurgery, Colonoscopy  
Number of Participants  
[units: participants]
  4  
Age  
[units: years]
Median ( Full Range )
  75.5  
  ( 74 to 82 )  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     0  
>=65 years     4  
Gender  
[units: participants]
 
Female     0  
Male     4  
Region of Enrollment  
[units: participants]
 
United States     4  



  Outcome Measures

1.  Primary:   Proportion of Patients With Endoscopically Detectable-telangiectasia (VRS Grade 1 or Higher).   [ Time Frame: 7 years ]

2.  Secondary:   Proportion of Patients With Rectal Bleeding.   [ Time Frame: 7 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Progression-free Survival   [ Time Frame: 7 Years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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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:  
Name/Title: Dr. Sean Collins
Organization: Georgetown University Hospital
phone: 202-444-3062
e-mail: spc9@gunet.georgetown.edu


No publications provided


Responsible Party: Sean Collins, M.D., PhD, Georgetown University
ClinicalTrials.gov Identifier: NCT01618838     History of Changes
Other Study ID Numbers: IRB 2009-474
Study First Received: June 12, 2012
Results First Received: March 21, 2014
Last Updated: March 21, 2014
Health Authority: United States: Institutional Review Board