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Assessing the Potential for Reduced Toxicity Using Focal Brachytherapy in Early Stage, Low Volume Prostate Cancer

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ClinicalTrials.gov Identifier: NCT01354951
Recruitment Status : Terminated (Lack of accrual)
First Posted : May 17, 2011
Results First Posted : October 19, 2018
Last Update Posted : October 19, 2018
Sponsor:
Collaborators:
University of Colorado, Denver
M.D. Anderson Cancer Center
Northwell Health
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Prostate Cancer
Intervention Other: Prostate Biopsy, Focal Brachytherapy , Assessment of QOL
Enrollment 3
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Prostate Biopsy, Focal Brachytherapy , Assessment of QOL
Hide Arm/Group Description This is a non-randomized, Phase II study examining the tolerance profile (primary endpoint) as well as the secondary endpoints of QOL changes, efficacy and the correlation of post-treatment MRI findings with post-treatment biopsy outcomes in men with early stage low volume prostate cancer treated with focal brachytherapy.
Period Title: Overall Study
Started 3
Completed 1
Not Completed 2
Arm/Group Title Prostate Biopsy, Focal Brachytherapy , Assessment of QOL
Hide Arm/Group Description This is a non-randomized, Phase II study examining the tolerance profile (primary endpoint) as well as the secondary endpoints of QOL changes, efficacy and the correlation of post-treatment MRI findings with post-treatment biopsy outcomes in men with early stage low volume prostate cancer treated with focal brachytherapy.
Overall Number of Baseline Participants 3
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 3 participants
57
(50 to 64)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
Female
0
   0.0%
Male
3
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
3
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
3
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 3 participants
3
 100.0%
1.Primary Outcome
Title To Assess the Late Toxicity Outcomes
Hide Description focal brachytherapy in patients with low risk prostate cancer This study will utilize the toxicity grading scale Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Time Frame 6 months to 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data not collected
Arm/Group Title Prostate Biopsy, Focal Brachytherapy , Assessment of QOL
Hide Arm/Group Description:
This is a non-randomized, Phase II study examining the tolerance profile (primary endpoint) as well as the secondary endpoints of QOL changes, efficacy and the correlation of post-treatment MRI findings with post-treatment biopsy outcomes in men with early stage low volume prostate cancer treated with focal brachytherapy.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title To Evaluate the Local Tumor Control After Focal Brachytherapy
Hide Description as measured by the ability to obtain all negative biopsy cores 12 and 24 months after completion of therapy in the hemi-gland of where the focal therapy was administered. “All negative” means no prostate cancer;
Time Frame 12 and 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data not collected
Arm/Group Title Prostate Biopsy, Focal Brachytherapy , Assessment of QOL
Hide Arm/Group Description:
This is a non-randomized, Phase II study examining the tolerance profile (primary endpoint) as well as the secondary endpoints of QOL changes, efficacy and the correlation of post-treatment MRI findings with post-treatment biopsy outcomes in men with early stage low volume prostate cancer treated with focal brachytherapy.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title To Evaluate the Change From Baseline in QOL Indicators
Hide Description Following focal brachytherapy in patients with early stage low volume localized prostate cancer. The scales to measure these domains were derived from the previously validated MSKCC Prostate-Health Related Quality of Life Questionnaire (PHRQOLQ
Time Frame baseline and then approximately 3 ± 1 months, 6 ± 1 months, 12 ± 2 months, 18 ± 2 months, and 24 ± 2 months after treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data not collected
Arm/Group Title Prostate Biopsy, Focal Brachytherapy , Assessment of QOL
Hide Arm/Group Description:
This is a non-randomized, Phase II study examining the tolerance profile (primary endpoint) as well as the secondary endpoints of QOL changes, efficacy and the correlation of post-treatment MRI findings with post-treatment biopsy outcomes in men with early stage low volume prostate cancer treated with focal brachytherapy.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title To Correlate Post-treatment MRI Findings With Post-treatment Biopsy Outcomes
Hide Description Post-treatment MRI outcome is defined as a 3-level categorical variable: positive, negative and undetermined. Post-treatment biopsy outcome is defined as a binary variable: positive and negative. We will examine the correlation between the 12-month MRI and 12-month biopsy, and between the 24-month MRI and 24-month biopsy. The correlation will be assessed by a Fisher exact test.
Time Frame 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data not collected
Arm/Group Title Prostate Biopsy, Focal Brachytherapy , Assessment of QOL
Hide Arm/Group Description:
This is a non-randomized, Phase II study examining the tolerance profile (primary endpoint) as well as the secondary endpoints of QOL changes, efficacy and the correlation of post-treatment MRI findings with post-treatment biopsy outcomes in men with early stage low volume prostate cancer treated with focal brachytherapy.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 24 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Prostate Biopsy, Focal Brachytherapy , Assessment of QOL
Hide Arm/Group Description This is a non-randomized, Phase II study examining the tolerance profile (primary endpoint) as well as the secondary endpoints of QOL changes, efficacy and the correlation of post-treatment MRI findings with post-treatment biopsy outcomes in men with early stage low volume prostate cancer treated with focal brachytherapy.
All-Cause Mortality
Prostate Biopsy, Focal Brachytherapy , Assessment of QOL
Affected / at Risk (%)
Total   0/3 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Prostate Biopsy, Focal Brachytherapy , Assessment of QOL
Affected / at Risk (%)
Total   0/3 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Prostate Biopsy, Focal Brachytherapy , Assessment of QOL
Affected / at Risk (%)
Total   1/3 (33.33%) 
Gastrointestinal disorders   
Fecal incontinence   1/3 (33.33%) 
Investigations   
Alanine aminotransferase increased   1/3 (33.33%) 
Metabolism and nutrition disorders   
Hyperglycemia   1/3 (33.33%) 
Renal and urinary disorders   
Urinary frequency   1/3 (33.33%) 
Urinary urgency   1/3 (33.33%) 
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Michael Zelefsky, MD
Organization: Memorial Sloan Kettering Cancer Center
Phone: 212-639-6802
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01354951     History of Changes
Other Study ID Numbers: 11-056
First Submitted: May 16, 2011
First Posted: May 17, 2011
Results First Submitted: March 19, 2018
Results First Posted: October 19, 2018
Last Update Posted: October 19, 2018