Trial Outcomes & Findings for A Prospective, Randomized Trial Comparing Office-based MR-guided Prostate Biopsy Approaches (NCT NCT03632655)
NCT ID: NCT03632655
Last Updated: 2024-05-31
Results Overview
Detection of clinically significant disease Typical Gleason Scores range from 6-10. The higher the Gleason Score, the more likely that the cancer will grow and spread quickly. * Scores of 6 or less describe cancer cells that look similar to normal cells and suggest that the cancer is likely to grow slowly. * A score of 7 suggests and intermediate risk for aggressive cancer. Scoring a 7 means that the primary score (largest section of the tumor) scored a 3 or 4. Tumors with a primary score of 3 and a secondary score of 4 have a fairly good outlook, whereas cancers with a primary Gleason Score of 4 and a secondary score of 3, are more likely to grow and spread. * Scores of 8 or higher describe cancers that are likely to spread more rapidly, these cancers are often referred to as poorly differentiated or high grade.
TERMINATED
NA
38 participants
7 days post-biopsy
2024-05-31
Participant Flow
Participant milestones
| Measure |
Transrectal Ultrasound Guided Biopsy (TRUS)
Patients will receive a transrectal guided prostate biopsy
prostate biopsy: Men will be randomized to receiving either TPM or TRUS targeted biopsy
|
Transperineal Prostate Biopsy
Patients will receive a transperineal prostate biopsy
prostate biopsy: Men will be randomized to receiving either TPM or TRUS targeted biopsy
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
16
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
22
|
16
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Prospective, Randomized Trial Comparing Office-based MR-guided Prostate Biopsy Approaches
Baseline characteristics by cohort
| Measure |
Transrectal Ultrasound Guided Biopsy (TRUS)
n=22 Participants
Patients will receive a transrectal guided prostate biopsy
prostate biopsy: Men will be randomized to receiving either TPM or TRUS targeted biopsy
|
Transperineal Prostate Biopsy
n=16 Participants
Patients will receive a transperineal prostate biopsy
prostate biopsy: Men will be randomized to receiving either TPM or TRUS targeted biopsy
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63 years
n=5 Participants
|
69 years
n=7 Participants
|
64 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
22 participants
n=5 Participants
|
16 participants
n=7 Participants
|
38 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 7 days post-biopsyPopulation: The data was not collected due to the trial being terminated.
Detection of clinically significant disease Typical Gleason Scores range from 6-10. The higher the Gleason Score, the more likely that the cancer will grow and spread quickly. * Scores of 6 or less describe cancer cells that look similar to normal cells and suggest that the cancer is likely to grow slowly. * A score of 7 suggests and intermediate risk for aggressive cancer. Scoring a 7 means that the primary score (largest section of the tumor) scored a 3 or 4. Tumors with a primary score of 3 and a secondary score of 4 have a fairly good outlook, whereas cancers with a primary Gleason Score of 4 and a secondary score of 3, are more likely to grow and spread. * Scores of 8 or higher describe cancers that are likely to spread more rapidly, these cancers are often referred to as poorly differentiated or high grade.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At time of local anesthesia administration, initiation of biopsy, immediately following biopsy, 7 days post-biopsy, 3 months post-biopsyPopulation: The data was not collected due to the trial being terminated.
Pain will be scored on a 0-10 Likert scale. 0 indicates no pain and high scores indicate greater pain.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline, 7 days post-biopsy, 30 days post-biopsyPopulation: The data was not collected due to the trial being terminated.
IPSS scores range from 1 to 35, with 1-7 indicating mild symptoms, 8-19 indicating moderate symptoms, 20-35 indicating severe symptoms.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline, 7 days post-biopsy, 30 days post-biopsyPopulation: The data was not collected due to the trial being terminated.
IIEF-5 scores range from 1 to 25, with 1-7 indicating severe erectile dysfunction, 8-11 indicating moderate erectile dysfunction, 12-16 indicating mild-moderate erectile dysfunction, 17-21 indicating mild erectile dysfunction, and 22-25 indicating no erectile dysfunction.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline, 7 days post-biopsy, 30 days post-biopsyPopulation: The data was not collected due to the trial being terminated.
EPIC-CP comprises of 10 questions about the patient within the last four weeks. Questions 1,7,8,9 are each graded on a scale from 0-4 for a total of 12 points. Higher scores indicate worse quality of life with regards to urinary and sexual function. Questions 2-4 grade Urinary Incontinence Symptoms on a scale from 0-4 (max 12 points). Higher scores indicate worse urinary incontinence symptoms. Questions 5a-c grade Urinary Irritation/Obstructive Symptoms on a scale from 0-4 (max 12 poitns). Higher scores indicate worse urinary irritation/obstructive symptoms. Questions 6a-c grade Bowel Symptoms on a scale from 0-4 (max 12 points). Higher scores indicate worse bowel symptoms. Questions 10a-c grade Vitality/Hormonal Symptoms on a scale from 0-4 (max 12 points). Higher scores indicate worse vitality/hormonal symptoms. All scores are summed (max 60 points) to calculate the Overall Prostate Cancer QOL score. Higher score indicates worse patient-reported QOL.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: initiation of biopsy, immediately following biopsy, 7 days post-biopsy, 30 days post-biopsyPopulation: The data was not collected due to the trial being terminated.
Adverse events that have occurred, such as hospital re-admissions, aborted procedures due to discomfort, hematuria, urinary retention, hematospermia, hematochezia, and/or infection.
Outcome measures
Outcome data not reported
Adverse Events
Transrectal Ultrasound Guided Biopsy (TRUS)
Transperineal Prostate Biopsy
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place