Trial Outcomes & Findings for Contrast Enhanced Transrectal Ultrasonography (TRUS) to Assess Prostatic Vascularity After Radiotherapy (XRT) (NCT NCT00635167)

Results Overview

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

1 participants

Primary outcome timeframe

1 year

Results posted on

2025-05-16

Participant Flow

Participant milestones

Participant milestones
Measure	Contrast Enhanced Transrectal Ultrasound (TRUS) Contrast Enhanced-Transrectal Ultrasound: Drug Once a subject is identified TRUS schedule will be set up revolving around the EBRT treatment schedule. A schedule of 6 contrast enhanced TRUS examinations per subject is planned as follows: week 0 (prior to EBRT, baseline \[Visit 2\]); week 5 (middle of treatment \[Visit 3\]); week 10 (end of treatment \[Visit 4\]); week 18 (2 months after end of EBRT \[Visit 5\]); week 26 (4 months after end of EBRT \[Visit 6\]); and week 36 (6 months after end of EBRT \[Visit 7\]).
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Contrast Enhanced Transrectal Ultrasonography (TRUS) to Assess Prostatic Vascularity After Radiotherapy (XRT)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Contrast Enhanced Transrectal Ultrasound (TRUS) n=1 Participants Contrast Enhanced-Transrectal Ultrasound: Drug Once a subject is identified TRUS schedule will be set up revolving around the EBRT treatment schedule. A schedule of 6 contrast enhanced TRUS examinations per subject is planned as follows: week 0 (prior to EBRT, baseline \[Visit 2\]); week 5 (middle of treatment \[Visit 3\]); week 10 (end of treatment \[Visit 4\]); week 18 (2 months after end of EBRT \[Visit 5\]); week 26 (4 months after end of EBRT \[Visit 6\]); and week 36 (6 months after end of EBRT \[Visit 7\]).
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	0 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Region of Enrollment United States	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Population: This trial did not accrue well and was terminated prematurely. No data were not collected or analyzed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 year

Population: This trial did not accrue well and was terminated prematurely. No data were not collected or analyzed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 year

Population: This trial did not accrue well and was terminated prematurely. No data were not collected or analyzed.

Outcome measures

Outcome data not reported

Adverse Events

Contrast Enhanced Transrectal Ultrasound (TRUS)

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

Dr. Edouard Trabulsi

Sidney Kimmel Cancer Center at Thomas Jefferson University

Phone: 215-955-1000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place