This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Multi-Center Trial of High-resolution Transrectal Ultrasound Versus Standard Low-resolution Transrectal Ultrasound for the Identification of Clinically Significant Prostate Cancer (NCT02079025), a randomized na study. The primary outcome is Percentage of Participants With Clinically Significant Prostate Cancer.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02079025 |
| Phase | NA |
| Condition | Prostatic Neoplasms, Prostate Cancer, Cancer of the Prostate |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 1676 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Exact Imaging |
| Results posted | Yes |
2. Clinical Question
Population
Men without known prostate cancer who had an indication for prostate biopsy. The registry record describes an intent-to-treat population that includes all subjects and a per-protocol population that includes only subjects without protocol deviations.
Intervention
Ultra-high-resolution transrectal ultrasound-guided prostate biopsy (UHR-TRUS), using a high-resolution ultrasound system and specialized transducer.
Comparator
Standard low-resolution transrectal ultrasound-guided prostate biopsy (LR-TRUS), described as standard of care.
Primary question
Does UHR-TRUS identify clinically significant prostate cancer more effectively than LR-TRUS among men undergoing biopsy? The registry record states this as the primary objective, but does not report a numerical outcome comparison or statistical analysis.
3. Trial Design
This was a randomized, parallel-group, open-label trial comparing high-resolution and standard low-resolution transrectal ultrasound-guided prostate biopsy. The registry record lists Exact Imaging as the sponsor and records the study as completed. Enrollment is listed as 1676. The study start is recorded as 2013-12 and primary completion as 2016-12. Phase is listed as NA.
The trial concerned men without known prostate cancer who had an indication for prostate biopsy. Participants were assigned to UHR-TRUS, described as ultra-high-resolution transrectal ultrasound-guided biopsy, or LR-TRUS, described as low-resolution transrectal ultrasound-guided biopsy and standard of care. The registry record does not describe allocation concealment or the randomization procedure. Masking is listed as none; it does not further explain which trial personnel, if any, knew assignment.
The primary objective was to demonstrate superiority of UHR-TRUS over LR-TRUS for detecting clinically significant cancer. Secondary objectives concerned investigator detection before and after training, and combined sensitivity and specificity for image-guided biopsy. These objectives distinguish detection performance from changes in investigator performance following training. The registry record does not report the results of those comparisons.
Participant involvement was described as complete following biopsy, and the primary outcome timeframe was the first visit. The record describes planned interim analyses beginning when 800 patients had been enrolled, followed by further looks after every additional 200 patients, up to a maximum sample size of 2000. Whether these interim analyses were conducted, and how any repeated looks were handled, is not reported in the registry record.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | LR-TRUS | UHR-TRUS |
|---|---|---|
| STARTED | 839 | 837 |
| COMPLETED | 839 | 837 |
| NOT COMPLETED | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: Intent To Treat includes all subjects, Per Protocol includes only subjects without protocol deviations.
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | LR-TRUS | UHR-TRUS | Total |
|---|---|---|---|---|
| Participants analysed | 839 | 837 | 1676 | |
| Age, Continuous | years | 62.6 (SD 8.67) | 62.7 (SD 8.66) | 62.7 (SD 8.66) |
| Sex: Female, Male: Female | Participants | 0 | 0 | 0 |
| Sex: Female, Male: Male | Participants | 839 | 837 | 1676 |
| Race and Ethnicity Not Collected | Participants | — | — | 0 |
| Region of Enrollment: Canada | participants | 279 | 272 | 551 |
| Region of Enrollment: United States | participants | 560 | 565 | 1125 |
6. Primary Endpoint
The registry lists the primary outcome as Percentage of Participants With Clinically Significant Prostate Cancer, measured over First visit (a patient's involvement in the trial is complete following his biopsy)..
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | percentage of participants with csPCa |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the percentage of participants with clinically significant prostate cancer, based on pathology review of prostate biopsy. In this study, the endpoint is intended to represent whether cancer found in biopsy tissue meets the study’s definition of clinical significance. The registry record does not give that definition, so the precise pathology criteria cannot be assessed from the record.
A percentage endpoint expresses how often the event of interest is observed within a defined participant group. Comparing this endpoint between randomized groups can address whether the biopsy approaches differ in cancer detection within the enrolled population. It is a detection outcome, not by itself a measure of long-term patient outcomes or the full diagnostic accuracy of each approach. The registry record separately lists combined sensitivity and specificity as a tertiary objective.
The timeframe is the first visit, and the record says a participant’s involvement ends after biopsy. It defines an intent-to-treat population as all subjects and a per-protocol population as subjects without protocol deviations. However, the registry record does not report endpoint counts, percentages, uncertainty estimates, or an analysis comparing the groups. It therefore does not establish the magnitude or precision of any difference in this primary outcome.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies the clinical question and design but does not post the primary endpoint results. The primary measure is the percentage of participants with clinically significant prostate cancer identified through biopsy pathology. No arm-specific counts or percentages, treatment contrast, confidence interval, or p-value are reported in the registry record. The statistical evidence for superiority therefore cannot be evaluated from the posted information.
The record lists 1676 enrolled participants and describes randomized assignment to UHR-TRUS or LR-TRUS. Enrollment alone does not establish how many participants contributed to the endpoint in each group, whether all randomized participants received the assigned procedure, or whether any results were excluded. The record’s definitions of intent-to-treat and per-protocol populations do not indicate which population was used for a primary analysis. No analyses are listed in the registry record.
The study description says interim analyses were planned beginning at enrollment of 800 patients, with further analyses after each additional 200 patients, up to a maximum sample size of 2000. Those plans are relevant because reviewing accumulating data can affect how evidence is interpreted, particularly if repeated looks influence the decision threshold. Whether the analyses occurred, what methods were used, and whether they affected the final analysis are not reported in the registry record. A plan alone is not evidence that interim analyses were performed.
The study also sought to compare investigator performance before and after training, and to assess combined sensitivity and specificity. These are distinct questions. A change in detection after training would not by itself establish an overall difference between devices, while sensitivity and specificity describe different aspects of diagnostic classification. The registry record does not provide results for these objectives, nor does it give the definitions or methods needed to interpret them quantitatively.
In general, an estimate describes the observed contrast, while a confidence interval describes the range of values compatible with the data under the analysis assumptions. A p-value addresses compatibility with a specified null hypothesis; it does not state the probability that a device is effective or ineffective. None of these inferential quantities is reported for the primary outcome. Consequently, readers cannot judge the estimated size, direction, or precision of the primary comparison from this record alone. The appropriate conclusion is limited to what the record documents: a randomized trial was completed and its objectives were registered, but the posted record does not contain the numerical outcome analysis needed to assess the primary question.
9. Statistical Methods Explained
The registry record describes randomized allocation and a parallel-group comparison. In a randomized trial, assignment is intended to make groups comparable with respect to measured and unmeasured characteristics on average. Randomization does not remove the need to report the analysis: readers still need group-specific outcome data and a clearly identified comparison to assess the result. The registry record does not report the randomization procedure, allocation concealment, or a numerical outcome analysis.
What does a percentage endpoint represent?
In general, an endpoint expressed as a percentage describes the frequency of an event within a defined group. Here, the event is clinically significant prostate cancer found on pathology review of biopsy. Interpreting a percentage requires knowing both the number with the event and the number assessed in the relevant group. Those counts and percentages are not reported in the registry record. No comparison between the randomized groups can therefore be reconstructed from the enrollment total alone.
The registry record gives the endpoint timeframe as the first visit and says participant involvement is complete following biopsy. It does not report whether every randomized participant underwent biopsy, whether pathology assessments were available for all participants, or how any unavailable assessments were handled. These details matter because an endpoint’s denominator and the handling of participants without an observed outcome affect the interpretation of the resulting estimate.
How should a group comparison be assessed?
In general, a treatment contrast quantifies the difference between groups on a defined outcome scale. A confidence interval communicates uncertainty around that estimate, conditional on the data and statistical assumptions. A p-value evaluates compatibility with a specified null hypothesis under a statistical model. Neither a confidence interval nor a p-value substitutes for the estimated effect and its context. The record reports none of these quantities for the primary endpoint, so the direction, size, and precision of the comparison are not available.
The primary objective is phrased as a superiority question. Assessing superiority requires a prespecified comparison and an analysis that accounts for the outcome definition, analysis population, and any design features that affect inference. The statistical test, effect measure, confidence level, and analysis model are not reported in the registry record. A detailed statistical analysis plan is also not reported in the registry record.
What do the secondary objectives add?
The secondary objective compares detection before and after investigator training. This asks whether investigators’ ability to detect clinically significant cancer changed with training. The record does not describe the training procedure, the timing or structure of those assessments, or the statistical method for comparing them. The tertiary objective concerns combined sensitivity and specificity for cancer detection overall. In general, sensitivity concerns detection among those with the condition, whereas specificity concerns correct classification among those without it. Because they capture different diagnostic properties, a combined summary needs a clearly stated definition and supporting data. Those details and results are not reported in the registry record.
How do interim looks affect interpretation?
The primary outcome description states that interim analyses were planned beginning at enrollment of 800 patients, followed by additional analyses after every further 200 patients up to a maximum sample size of 2000. In general, repeated examination of accumulating results can increase the chance of a false-positive finding if the decision rules do not account for repeated testing. Methods such as prespecified stopping boundaries or adjusted thresholds can address that issue, but the registry record does not report whether interim analyses occurred or what procedures, if any, were used. The planned schedule should not be treated as proof of a particular interim-analysis method.
A sample-size calculation depends on assumptions about the expected effect, variability or event frequency, allocation, significance threshold, and desired power. The record includes a general planning-illustration description using a two-sided significance level of 0.05, equal allocation, and a normal approximation, with effects expressed as fractions of the observed effect. It does not report a trial-specific sample-size justification or the numerical planning illustrations in the record. Such planning estimates, where available, would describe design assumptions rather than observed power after trial completion.
10. Multiplicity, Missing Data and Analysis Populations
The study includes a primary endpoint, secondary objectives concerning investigator performance before and after training, and a tertiary objective concerning combined sensitivity and specificity. Testing multiple outcomes or comparisons can increase the chance of at least one apparently positive result arising by chance. In general, multiplicity can be addressed through a prespecified hierarchy, adjusted testing thresholds, or other stated procedures. The registry record does not report a multiplicity strategy, so it is not possible to determine how the several objectives were incorporated into confirmatory inference.
The primary outcome description also states that interim analyses were planned, beginning at enrollment of 800 patients and continuing after every additional 200 patients up to a maximum sample size of 2000. Repeated analyses can create another multiplicity concern if the statistical decision rules do not account for them. Whether these analyses were conducted, and what approach was used to preserve the intended error rate, is not reported in the registry record.
The record defines an intent-to-treat population as all subjects and a per-protocol population as subjects without protocol deviations. These definitions do not establish which population was used for any analysis. No analyses are listed. The number of participants with missing endpoint data, reasons for missingness, imputation methods, and sensitivity analyses are not reported in the registry record. The record also does not state how protocol deviations were identified or handled in an analysis.
These omissions limit assessment of whether the reported findings, if available elsewhere, would be robust to analysis-population choices, missing outcomes, or multiple testing. They do not show that data were missing or that a particular analysis method was inappropriate; those details are simply not reported in the registry record.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| LR-TRUS | 3 | 839 | 0.4% |
| UHR-TRUS | 3 | 837 | 0.4% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| LR-TRUS | 0 of 839 |
| UHR-TRUS | 0 of 837 |
Most frequent serious adverse event terms
| Event term | Organ system | LR-TRUS | UHR-TRUS |
|---|---|---|---|
| post-biopsy bacteremia | Infections and infestations | 3 of 839 | 3 of 837 |
Serious events with the highest arm-level rate: post-biopsy bacteremia (0.4%).
The registry record lists serious adverse events for 839 participants at risk in the LR-TRUS group, with 3 affected, and 837 participants at risk in the UHR-TRUS group, also with 3 affected. For other adverse events, the listed at-risk counts are 839 for LR-TRUS and 837 for UHR-TRUS, with 0 affected in each group. The record identifies post-biopsy bacteremia as a top serious event term and gives 0.4% alongside that term. It does not specify the arm-specific distribution of that event in the information recorded.
These entries are descriptive counts, not a complete comparative safety analysis. The record does not provide event-level detail, severity grades beyond the serious-event category, exposure-adjusted rates, statistical comparisons, or the criteria used for event attribution. Death counts are not reported in the registry record. The listed at-risk counts should not be interpreted as proof that every participant completed the same safety follow-up, because the follow-up details are not reported.
In general, small event counts can make estimates imprecise, and a lack of a reported comparison does not establish equivalence between groups. The posted figures describe the adverse-event entries recorded in the registry; they do not by themselves determine whether the procedures have similar safety profiles.
12. What the Result Does, and Does Not, Mean
This trial addresses a practical diagnostic question: whether high-resolution ultrasound guidance identifies clinically significant prostate cancer differently from standard low-resolution ultrasound guidance during prostate biopsy. Its randomized, parallel-group design is suited to comparing the assigned approaches, and the record identifies the intended population and pathology-based primary endpoint.
The registry record does not report numerical results for the primary outcome or the secondary and tertiary objectives. It therefore does not show the observed direction or size of any difference, nor how precise an estimate might be. Without group-specific endpoint data and an inferential analysis, readers cannot determine from this record whether the primary superiority objective was met.
The endpoint concerns cancer detected in biopsy specimens at the first visit. It does not, by itself, establish longer-term outcomes, the consequences of false-positive or false-negative findings, or the performance of either approach in populations outside the described trial population. The registry record does not report the pathology criteria for clinical significance, so the endpoint’s exact operational definition cannot be assessed.
The study also registered objectives relating to investigator training and diagnostic sensitivity and specificity. These address additional aspects of performance, but their results and analytical details are not reported. The safety entries list serious-event counts in both groups and identify post-biopsy bacteremia as a top serious event term, but the record does not report a comparative safety analysis. These descriptive entries should not be read as proof of equal risk.
Accordingly, the posted record establishes that the trial was randomized, completed, and designed to compare the biopsy approaches. It does not provide enough outcome information to conclude that one approach performed better, worse, or similarly. This is a limit of the registry record, not evidence that the trial found no difference.
13. Why This Trial Matters Statistically
The trial is statistically relevant because it frames an imaging-device comparison as a randomized evaluation of a defined diagnostic endpoint. Randomized allocation can support a fair comparison of assigned approaches when the allocation, follow-up, outcome assessment, and analysis are adequately reported. The registry record identifies the parallel-group design and open-label masking status, giving readers an initial account of how the comparison was structured.
The primary endpoint links the imaging-guided biopsy procedure to a pathology finding: clinically significant prostate cancer. This makes the endpoint clinically interpretable as a detection measure, while also highlighting the need for a reproducible definition of clinical significance. The registry record does not provide the pathology criteria or numerical results, so the reproducibility and observed performance cannot be judged from this record.
The registered objectives also point to statistical questions beyond a simple group contrast. Investigator training could affect detection performance, and sensitivity and specificity represent different dimensions of diagnostic classification. A credible interpretation of these objectives requires clear definitions, prespecified analyses, and results for each objective. Those analytical details and results are not reported in the registry record.
The planned interim analyses are another important design feature. Repeatedly assessing accumulating data can be useful in some trial designs, but the statistical interpretation depends on prespecified monitoring procedures and how they shape the final analysis. The registry record gives a planned enrollment schedule for interim analyses but does not say whether they occurred or how they were handled.
The record therefore illustrates why design registration and results reporting serve different roles. The design description identifies the question and planned approach; complete outcome reporting is needed to estimate effects, quantify uncertainty, and assess the implications of multiple objectives and interim looks. Without those results, the clinical question remains statistically unresolved in the posted registry record.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The main limitation for interpretation is the absence of posted numerical results for the primary endpoint. The registry record does not report the number of participants with clinically significant prostate cancer in either group, endpoint percentages, an effect estimate, confidence intervals, or a p-value. The registry indicates no analyses, so the primary comparison cannot be evaluated from the record.
The endpoint’s pathology basis is described, but the criteria for classifying cancer as clinically significant are not reported in the registry record. The record also does not report how pathology was assessed, whether assessment was blinded to assigned group, or how differences in assessment were resolved. Masking for the trial is listed as none, but the record does not clarify masking for each aspect of outcome assessment.
Although the record defines intent-to-treat and per-protocol populations, it does not report which population was used in an analysis. Participant flow by group, receipt of assigned procedures, protocol deviations, missing outcome counts, and approaches to missing data are not reported in the registry record. These details are needed to understand the analysis denominator and the potential influence of exclusions or unavailable pathology.
Interim analyses were planned, but whether they were conducted and how repeated testing was addressed is not reported. The statistical analysis plan, trial-specific sample-size justification, and multiplicity procedures are also not reported in the registry record. The record’s secondary objectives include investigator training and combined sensitivity and specificity, but their definitions, methods, and numerical results are absent.
Safety reporting is limited to listed event counts and a top serious event term; deaths and fuller comparative safety methods are not reported. These reporting gaps prevent a complete assessment of efficacy, precision, analysis robustness, and safety. They should not be mistaken for evidence that a particular result or analysis was absent from the trial itself; they describe what is not reported in the registry record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Multi-Center Trial of High-resolution Transrectal Ultrasound Versus Standard Low-resolution Transrectal Ultrasound for the Identification of Clinically Significant Prostate Cancer — NCT02079025.
- Registry record last updated 2019-02-26; status last verified 2019-02.
- Results first posted 2019-01-08.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
NCT02079025 is a completed, randomized, parallel-group, open-label trial sponsored by Exact Imaging. It enrolled 1676 participants and compared ultra-high-resolution transrectal ultrasound-guided prostate biopsy with standard low-resolution transrectal ultrasound-guided biopsy in men without known prostate cancer who had an indication for biopsy. The study start is recorded as 2013-12, with primary completion at 2016-12.
The primary objective concerned detection of clinically significant prostate cancer, assessed through pathology review of biopsy. Secondary objectives concerned investigator detection before and after training, and a tertiary objective concerned combined sensitivity and specificity. The record describes planned interim analyses but does not report whether they occurred.
No analyses are listed, and numerical results for the primary or other objectives are not reported in the registry record. Serious adverse-event counts are listed for both groups, and post-biopsy bacteremia is named as a top serious event term. The record does not provide a comparative outcome analysis or a complete safety interpretation.