Trial · NCT02079025
Multi-Center Trial of High-resolution Transrectal Ultrasound Versus Standard Low-resolution Transrectal Ultrasound for the Identification of Clinically Significant Prostate Cancer
NCT02079025, Not applicable, Completed, Exact Imaging; results first posted 2019-01-08
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Multi-Center Trial of High-resolution Transrectal Ultrasound Versus Standard Low-resolution Transrectal Ultrasound for the Identification of Clinically Significant Prostate Cancer. Trials, record NCT02079025. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02079025
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Multi-Center Trial of High-resolution Transrectal Ultrasound Versus Standard Low-resolution Transrectal Ultrasound for the Identification of Clinically Significant Prostate Cancer
- NCT number
- NCT02079025
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 1,676 participants, actual
- Lead sponsor
- Exact Imaging
- Conditions
- Prostatic Neoplasms, Prostate Cancer, Cancer of the Prostate
- Interventions
- High-resolution ultrasound guided prostate biopsy, Standard ultrasound guided prostate biopsy
- First posted
- 2014-03-05
- Last updated
- 2019-02-26
- Results first posted
- 2019-01-08
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Clinically Significant Prostate Cancer | First visit (a patient's involvement in the trial is complete following his biopsy). | Pathology analysis of prostate biopsy is reviewed for indication of clinically significant prostate cancer. Interim analyses are planned beginning when 800 patients have been enrolled and after every additional 200 patients are enrolled up to the maximum sample size of 2000 patients. |
| Secondary | Improvement of an Investigator's Ability to Detect Clinically Significant Cancer Using UHR-TRUS Post-training When Compared to Pre-training | Pre-training refers to all biopsy procedures occurring between initial training and mid-trial PRI-MUS training. Post-training refers to all biopsy procedures performed after mid-trial PRI-MUS training. | Comparison of pre- and post-training percentage of participants found to harbor clinically significant prostate cancer within the UHR-TRUS arm of the trial |
| Secondary | Combined Sensitivity and Specificity in Determining Cancer Detection Overall for Image-guided Biopsy | First visit (a patient's involvement in the trial is complete following his biopsy). | Pathology analysis of prostate biopsy is reviewed. Sensitivity of targeted biopsy for each arm will be calculated as the number of targeted biopsy that also found cancer among all targeted biopsies. Specificity of targeted biopsy for each arm will be calculated as the number of non-targeted biopsies that find no cancer among all non-targeted biopsies. Interim analyses are planned beginning when 800 patients have been enrolled and after every additional 200 patients are enrolled up to the maximum sample size of 2000 patients. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Clinically Significant Prostate Cancer | First visit (a patient's involvement in the trial is complete following his biopsy). | Intent To Treat includes all subjects, Per Protocol includes only subjects without protocol deviations. | percentage of participants with csPCa | NUMBER |
| SECONDARY | Improvement of an Investigator's Ability to Detect Clinically Significant Cancer Using UHR-TRUS Post-training When Compared to Pre-training | Pre-training refers to all biopsy procedures occurring between initial training and mid-trial PRI-MUS training. Post-training refers to all biopsy procedures performed after mid-trial PRI-MUS training. | Pre and post-training detection rate for csPCa for the UHR-TRUS arm only (as investigators received additional training on this imaging modality) | Percentage of subjects with csPCa | NUMBER |
| SECONDARY | Combined Sensitivity and Specificity in Determining Cancer Detection Overall for Image-guided Biopsy | First visit (a patient's involvement in the trial is complete following his biopsy). | percentage of post-training samples | NUMBER |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Clinically Significant Prostate Cancer | LR-TRUS | Intent to Treat | 36.6 | percentage of participants with csPCa | |
| Percentage of Participants With Clinically Significant Prostate Cancer | UHR-TRUS | Intent to Treat | 34.6 | percentage of participants with csPCa | |
| Percentage of Participants With Clinically Significant Prostate Cancer | LR-TRUS | Per Protocol | 36.6 | percentage of participants with csPCa | |
| Percentage of Participants With Clinically Significant Prostate Cancer | UHR-TRUS | Per Protocol | 43.7 | percentage of participants with csPCa | |
| Improvement of an Investigator's Ability to Detect Clinically Significant Cancer Using UHR-TRUS Post-training When Compared to Pre-training | UHR-TRUS | Pre-Training | 32.4 | Percentage of subjects with csPCa | |
| Improvement of an Investigator's Ability to Detect Clinically Significant Cancer Using UHR-TRUS Post-training When Compared to Pre-training | UHR-TRUS | Post-Training | 39.0 | Percentage of subjects with csPCa | |
| Combined Sensitivity and Specificity in Determining Cancer Detection Overall for Image-guided Biopsy | LR-TRUS | Sensitivity | 38.0 | percentage of post-training samples | |
| Combined Sensitivity and Specificity in Determining Cancer Detection Overall for Image-guided Biopsy | UHR-TRUS | Sensitivity | 60.8 | percentage of post-training samples | |
| Combined Sensitivity and Specificity in Determining Cancer Detection Overall for Image-guided Biopsy | LR-TRUS | Specificity | 89.5 | percentage of post-training samples | |
| Combined Sensitivity and Specificity in Determining Cancer Detection Overall for Image-guided Biopsy | UHR-TRUS | Specificity | 63.2 | percentage of post-training samples |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | LR-TRUS | 839 | |
| Overall Study | STARTED | UHR-TRUS | 837 | |
| Overall Study | COMPLETED | LR-TRUS | 839 | |
| Overall Study | COMPLETED | UHR-TRUS | 837 | |
| Overall Study | NOT COMPLETED | LR-TRUS | 0 | |
| Overall Study | NOT COMPLETED | UHR-TRUS | 0 |
Source ClinicalTrials.gov
Adverse events2
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | post-biopsy bacteremia | Infections and infestations | LR-TRUS | 3 | 839 | 3 |
| serious | post-biopsy bacteremia | Infections and infestations | UHR-TRUS | 3 | 837 | 3 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | LR-TRUS | ||
| Total, all-cause mortality | UHR-TRUS | ||
| Total, other adverse events | LR-TRUS | 0 | 839 |
| Total, other adverse events | UHR-TRUS | 0 | 837 |
| Total, serious adverse events | LR-TRUS | 3 | 839 |
| Total, serious adverse events | UHR-TRUS | 3 | 837 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 29627083 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| LR-TRUS vs UHR-TRUS: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02079025
GET https://conductscience.org/api/trials/v1/NCT02079025/registered