Trial Outcomes & Findings for Fusion Targeted Biopsy of the Prostate (NCT NCT02013414)

NCT ID: NCT02013414

Last Updated: 2019-09-17

Results Overview

The feasibility of detecting cancer detection with the targeted prostate biopsy was assessed. This study sought only to determine if the targeted biopsy approach was able to detect recurrent prostate cancer and values for the number of samples testing positive for cancer per each biopsy approach are not available. This feasibility study preceded a clinical trial (NCT02744534) assessing the accuracy of prostate cancer detection with targeted biopsies compared to the standard biopsy.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 9 participants
• Primary outcome timeframe: Up to 2 years
• Results posted on: 2019-09-17

Participant Flow

Participant milestones

Measure	Targeted Biopsy and Template Biopsy Study participants with abnormal FACBC PET-CT scans received a fluciclovine PET ultrasound fusion targeted biopsy and a template (standard of care) biopsy to test the feasibility of targeted biopsies for detecting recurrent prostate cancer.
Overall Study STARTED	9
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Fusion Targeted Biopsy of the Prostate

Baseline characteristics by cohort

Measure	Targeted Biopsy and Template Biopsy n=9 Participants Study participants with abnormal FACBC PET-CT scans received a fluciclovine PET ultrasound fusion targeted biopsy and a template (standard of care) biopsy to test the feasibility of targeted biopsies for detecting recurrent prostate cancer.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants
Age, Continuous	72.08 years STANDARD_DEVIATION 1.80 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	9 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 2 years

Population: Only whether or not the targeted biopsy could detect cancer was examined and the number of positive biopsy cores per each biopsy approach were not determined.

The feasibility of detecting cancer detection with the targeted prostate biopsy was assessed. This study sought only to determine if the targeted biopsy approach was able to detect recurrent prostate cancer and values for the number of samples testing positive for cancer per each biopsy approach are not available. This feasibility study preceded a clinical trial (NCT02744534) assessing the accuracy of prostate cancer detection with targeted biopsies compared to the standard biopsy.

Outcome measures

Outcome data not reported

Adverse Events

Targeted Biopsy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Biopsy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Baowei Fei, PhD

Emory University

Phone: 972-883-7239

Email: bfei@utdallas.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place