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MR-Guided Laser Interstitial Thermal Therapy in Treating Patients With Prostate Cancer

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ClinicalTrials.gov Identifier: NCT01792024
Recruitment Status : Completed
First Posted : February 15, 2013
Results First Posted : March 13, 2018
Last Update Posted : March 13, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Chicago

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Stage I Prostate Cancer
Stage II Prostate Carcinoma
Interventions: Device: Visualase Thermal Therapy
Procedure: magnetic resonance imaging

  Participant Flow

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
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Reporting Groups
  Description
Treatment (LITT)

Patients undergo MR-guided laser ablation of prostate cancer

Visualase Thermal Therapy: MR guided laser ablation of prostate cancer

magnetic resonance imaging: Undergo MR-guided LITT


Participant Flow:   Overall Study
    Treatment (LITT)
STARTED   27 
COMPLETED   27 
NOT COMPLETED   0 



  Baseline Characteristics

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.
No text entered.

Reporting Groups
  Description
Treatment (LITT)

Patients undergo MR-guided laser ablation of prostate cancer

Visualase Thermal Therapy: MR guided laser ablation of prostate cancer

magnetic resonance imaging: Undergo MR-guided LITT


Baseline Measures
   Treatment (LITT) 
Overall Participants Analyzed 
[Units: Participants]
 27 
Age 
[Units: Years]
Median (Full Range)
 62 
 (47 to 81) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      0   0.0% 
Male      27 100.0% 


  Outcome Measures

1.  Primary:   Number of Participants With Undetectable Cancer on MRI-guided Biopsy of Ablation Zone Following Treatment   [ Time Frame: At 3 months after ablation ]

2.  Secondary:   The Number of Patients With Biopsy Cancer of the Treatment Zone   [ Time Frame: At 12 months ]

3.  Secondary:   The Total Number of Patients With Any Adverse Events Related to the Treatment   [ Time Frame: 1,3, and 12 month after treatment and up to 12 months ]

4.  Secondary:   Quality of Life in Terms of Urinary and Sexual Function in the Year Following Treatment Assessed Using the International Prostate Symptom Score (IPSS)   [ Time Frame: At 1,3 and 12 months ]

5.  Secondary:   Quality of Life in Terms of Urinary and Sexual Function in the Year Following Treatment Assessed Using Sexual Health Inventory in Men (SHIM)   [ Time Frame: At 1,3 and 12 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
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  More Information

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. Aytekin Oto
Organization: University of Chicago
phone: 773-834-7424
e-mail: aoto@radiology.bsd.uchicago.edu



Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01792024     History of Changes
Other Study ID Numbers: 12-1841
NCI-2013-00404 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
R21CA173751 ( U.S. NIH Grant/Contract )
First Submitted: February 12, 2013
First Posted: February 15, 2013
Results First Submitted: December 22, 2017
Results First Posted: March 13, 2018
Last Update Posted: March 13, 2018