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 Fusion Targeted Biopsy of the Prostate (NCT02013414), a na na study. The primary outcome is Cancer Detection by Targeted and Standard Biopsy Approaches.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02013414 |
| Phase | NA |
| Condition | Prostate Cancer |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 9 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Emory University |
| Results posted | Yes |
2. Clinical Question
Population
People with prostate cancer were the condition of interest. The registry lists an enrollment of 9 and describes assessing whether the targeted biopsy could detect recurrent prostate cancer. It does not report the clinical characteristics of participants or provide a detailed description of the population in which the primary outcome was assessed.
Intervention
The intervention was a 3D ultrasound-guided prostate biopsy. The proposed system could use three-dimensional ultrasound images to guide biopsy and record biopsy-core locations. It could also fuse MRI or PET images with ultrasound images to guide a needle toward a suspicious target.
Comparator
The registry names standard biopsy as another approach, and the intervention description contrasts targeted biopsy with standard 2D ultrasound-guided biopsy. However, the record identifies the study model as single group and allocation as not applicable. The listed approaches therefore do not establish a randomized, like-for-like control comparison.
Primary question
The feasibility question was whether the targeted approach could detect recurrent prostate cancer. The primary outcome description explicitly says that the number of biopsy samples testing positive for cancer for each approach was not determined or available. This means the record does not support a numerical comparison of detection between targeted and standard biopsy.
3. Trial Design
This was a completed, single-group device study sponsored by Emory University. The registry lists an enrollment of 9, identifies the intervention as 3D ultrasound-guided biopsy, and gives a timeframe of up to 2 years for the primary outcome. The stated aim was to evaluate a molecular image-directed, three-dimensional ultrasound-guided biopsy system in people.
The study description explains the technical motivation: standard biopsy uses two-dimensional ultrasound guidance, which can have sampling errors. The proposed system uses three-dimensional ultrasound imaging to guide biopsy, document core locations, and support re-biopsy to the same sites during a follow-up examination. It can also fuse MRI or PET images with 3D ultrasound images to direct the needle toward a suspicious target.
Although the registry lists targeted and standard biopsy labels in its adverse-event information and describes a contrast with standard biopsy, it classifies the study as single group and allocation as not applicable. The record therefore does not establish randomized assignment or a controlled comparison between the approaches. It also gives masking as none. Further details about the conduct of any comparison are not reported in the registry record.
The study status is completed. Its purpose was feasibility, not a reported estimate of comparative diagnostic accuracy. The registry says that this feasibility study preceded a later clinical trial assessing accuracy, but the present record does not provide results from that later study. No protocol details, statistical analysis plan, or sample-size justification are 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 | Targeted Biopsy and Template Biopsy |
|---|---|
| STARTED | 9 |
| COMPLETED | 9 |
| NOT COMPLETED | 0 |
Analysis population for the primary outcome, as defined in the registry: 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.
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 | Targeted Biopsy and Template Biopsy |
|---|---|---|
| Participants analysed | 9 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 1 |
| Age, Categorical: >=65 years | Participants | 8 |
| Age, Continuous | years | 72.08 (SD 1.80) |
| Sex: Female, Male: Female | Participants | 0 |
| Sex: Female, Male: Male | Participants | 9 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 |
| Race (NIH/OMB): White | Participants | 9 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Region of Enrollment: United States | Participants | 9 |
6. Primary Endpoint
The registry lists the primary outcome as Cancer Detection by Targeted and Standard Biopsy Approaches, measured over Up to 2 years.
| Element | Registry entry |
|---|---|
| Result type | N/A |
| Measure of spread | not applicable |
| Unit | not stated |
| Endpoint classification | not reduced to a single comparison |
The primary outcome is titled “Cancer Detection by Targeted and Standard Biopsy Approaches.” Its stated purpose was to assess the feasibility of detecting cancer with targeted prostate biopsy, specifically whether the targeted approach could detect recurrent prostate cancer. The outcome timeframe is up to 2 years.
The outcome is relevant to the proposed technology because the system is intended to guide biopsy toward a target identified from imaging, while also supporting systematic sampling and recording biopsy locations. In general, determining whether a biopsy approach can identify cancer is an initial feasibility question. Assessing comparative accuracy, however, requires outcome information that allows detection performance to be evaluated across approaches.
The registry explicitly says that the number of samples testing positive for cancer for each biopsy approach is not available and that positive biopsy cores per approach were not determined. It therefore does not provide a count, rate, or comparative estimate for this endpoint. The title’s reference to both approaches should not be read as evidence that a numerical head-to-head endpoint was analyzed. The record’s endpoint description limits the interpretation to whether detection was examined as a feasibility question, without reporting the positive-core results needed to quantify it.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The central statistical limitation is that the registry does not report a numerical cancer-detection result. It states that the feasibility question was whether targeted biopsy could detect recurrent prostate cancer, but also says that the number of positive samples for each approach was unavailable and that positive cores per approach were not determined. Consequently, there is no reported effect estimate to interpret, no uncertainty interval, and no numerical basis for comparing targeted with standard biopsy.
The registry lists an enrollment of 9. That enrollment figure is not a reported outcome denominator: the record does not state how many participants had evaluable biopsies, how many contributed to the primary assessment, or how missing or unusable assessments were handled. It should not be treated as the denominator for a detection proportion. Nor does the record provide participant-level outcomes from which a detection rate could be described.
The study is classified as single group, with allocation not applicable and no masking. The record includes descriptions of targeted and standard biopsy, but it explicitly cautions that the arms are not a like-for-like control comparison. These registry entries make causal or comparative claims inappropriate. In particular, no conclusion about the relative detection performance of the two approaches follows from the information recorded.
The adverse-event fields list zero counts for both named biopsy groups across the recorded risk and affected categories, including deaths. Those entries do not establish that adverse events were absent: the record does not explain whether these are complete observations, whether anyone was included in those categories, or how adverse events were collected. A zero in a registry field without accompanying ascertainment and denominator information is not a sufficient basis for a safety estimate.
Overall, the posted information documents the study’s feasibility objective, intervention, and limitations in outcome reporting. It does not provide the observed detection data or analytic results needed to quantify feasibility, diagnostic accuracy, uncertainty, or comparative benefit. No sponsor analysis or statistical result is listed in the registry record.
9. Statistical Methods Explained
The registry record gives a study model, outcome description, and some design labels, but does not report a statistical analysis plan or an analysis of the primary outcome. The methodological points below distinguish what the record says from general statistical principles; they do not imply that a particular analysis was performed.
What can a feasibility outcome establish?
In general, a feasibility study asks whether a procedure or measurement can be carried out and whether an outcome can be observed. A feasibility finding is not automatically an estimate of diagnostic accuracy. To estimate detection performance, investigators need clearly defined outcomes and denominators, along with an appropriate reference for determining whether disease was present. The registry describes a feasibility question about detecting recurrent cancer, but does not report positive-core counts or the participant-level data needed to calculate a detection proportion.
The record also says the number of positive biopsy cores for each approach was not determined. Core-level and participant-level outcomes answer different questions: a person can contribute multiple cores, while a participant-level detection outcome concerns whether cancer was detected for that person. The registry does not supply enough detail to determine which analysis population or unit of analysis would have been used for a numerical estimate.
Why does the design classification matter?
In general, random allocation can help make treatment groups comparable at baseline, while a prespecified control group makes the comparison being estimated clearer. This record classifies the study as single group and allocation as not applicable. It also describes targeted and standard approaches, but warns that the listed arms are not a like-for-like control comparison. Therefore, the arm labels alone cannot be treated as evidence of a randomized trial or as a basis for an unbiased comparative treatment effect.
Masking is listed as none. In general, lack of masking can matter when an outcome requires judgment, because knowledge of the procedure or assignment may influence assessment. Whether that concern affected this study, and what safeguards were used, are not reported in the registry record. The endpoint’s missing positive-core information makes it impossible to assess the potential impact on the recorded detection outcome.
What do estimates and confidence intervals require?
In general, an estimate is a numerical summary of observed data, and a confidence interval describes the uncertainty around that estimate under a specified statistical procedure. Neither can be interpreted without an outcome definition, observed data, and an analysis population. Here, the registry does not report a detection estimate or interval. It also does not list an analysis for the primary outcome. There is consequently no reported p-value or confidence interval to explain, and no basis for reconstructing one from the enrollment figure alone.
Small studies can yield imprecise estimates even when an outcome is observed. That general consideration does not resolve the more basic limitation in this record: the primary outcome values are not reported. No calculation of precision can substitute for missing outcome counts, and no inference about the result should be made from the study’s feasibility purpose or enrollment alone.
How should planning illustrations be read?
The registry includes assumptions for planning illustrations based on an observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It describes the effect to detect as a stated fraction of the observed effect. These are planning assumptions, not evidence that the original study was designed with those settings. The record does not report the study’s own sample-size justification or statistical plan.
In general, a sample-size calculation estimates the number of participants needed under specified assumptions about the effect, variability, allocation, and error rates. Such a calculation is not observed power and does not show that a study detected an effect. The planning illustrations are not a substitute for observed results, particularly when the record does not report the outcome data from which an effect could be evaluated. No additional planning values should be inferred from these assumptions.
Why might over-dispersion matter?
In general, over-dispersion occurs when count data vary more than a statistical model assumes. If the number of positive biopsy cores were analyzed as a count outcome, over-dispersion could make model-based standard errors too small unless the analysis accounted for the extra variability. This is a general methodological consideration only. The registry says positive cores per approach were not determined, and it does not report a count model or any other statistical analysis. It is therefore not possible to say whether over-dispersion arose or how it was handled.
More broadly, a reproducible interpretation would need a prespecified outcome definition, the unit of analysis, the analysis population, handling of missing or non-evaluable biopsies, and the statistical method used to estimate detection. Those details are not reported in the registry record. The record supports describing the study aim and data-reporting limitations, but not attributing an unreported statistical method or result to the investigators.
10. Multiplicity, Missing Data and Analysis Populations
The registry record does not report a statistical analysis plan, a multiplicity strategy, or an analysis of the primary outcome. It identifies one primary outcome measure, but the presence of a single listed primary measure does not reveal whether additional outcomes or exploratory analyses were planned. The record’s number of listed analyses is 0; no p-values or model results are reported. Whether interim analyses were planned or conducted is not reported in the registry record.
Missing-data handling is also not described. The registry does not state how many participants had an evaluable primary outcome, whether any biopsy was incomplete or non-evaluable, or how absent assessments would have been treated. Enrollment is not a substitute for the outcome denominator, and the record does not provide the data needed to assess missingness or its potential effect on a detection estimate.
The record specifies that positive biopsy-core counts by approach were not determined or available. This is more than a lack of detail about a statistical test: the outcome information needed for a numerical comparison is absent. The record also does not define an analysis population, such as which participants would be included in an endpoint analysis. These omissions prevent assessment of how participants were selected for analysis or whether results would differ under alternative analysis populations.
In general, multiplicity methods address the increased chance of false-positive findings when several hypotheses are tested. Missing-data methods address uncertainty when outcome values are unavailable. Neither can be evaluated without knowing the analyses planned and the observed data. The registry record does not report these details, so no claim about adjustment, imputation, or other handling is warranted.
11. What the Result Does, and Does Not, Mean
The registry supports a limited description of intent: the study evaluated a 3D ultrasound-guided, molecular image-directed biopsy system and asked whether targeted biopsy could detect recurrent prostate cancer. It also explains the proposed workflow, including recording biopsy-core locations and the potential fusion of MRI or PET images with 3D ultrasound. These are descriptions of the approach, not evidence of its diagnostic performance.
The record does not report how many samples tested positive for cancer under either approach. It therefore cannot show the size of a detection effect, the precision of such an effect, or whether targeted biopsy detected more or fewer cancers than standard biopsy. Because the study is classified as single group and the record warns against treating its arms as a like-for-like comparison, the listed approach labels do not support a causal comparison.
The enrollment figure describes registry enrollment, not a reported endpoint denominator. Without the number assessed and the outcome counts, it cannot be converted into a detection proportion. Likewise, the zero entries in adverse-event fields do not establish that there were no harms or that safety was comprehensively assessed; denominators and collection details are not reported.
In general, a feasibility study can inform whether a method warrants further evaluation, but that purpose does not itself demonstrate accuracy or clinical value. The record says this study preceded a clinical trial assessing accuracy, but it does not provide that trial’s results. The appropriate reading is therefore narrow: the registry documents a feasibility objective and technical approach, while leaving the central numerical detection outcome unreported. It neither establishes that the technology improves detection nor establishes that it does not.
12. Why This Trial Matters Statistically
This study is statistically notable because its stated clinical aim concerns detection, while its registry outcome description does not provide the positive-core data required to quantify detection by approach. That distinction matters: an objective can be clinically important, yet the available record may not contain the outcome information needed to estimate an effect or its uncertainty.
The design labels also matter. A single-group study and a record that explicitly cautions against a like-for-like control comparison do not support the same interpretation as a randomized comparative trial. Listing two biopsy approaches is not enough to establish that they were compared under conditions that permit a causal conclusion. Readers need to distinguish technical feasibility from comparative accuracy.
The record is useful in making the intended technology and the limits of the primary outcome explicit. It describes the use of 3D ultrasound, biopsy-site recording, and possible MRI or PET image fusion, while also stating that positive biopsy-core counts were not determined or available. This transparency helps prevent an aim or outcome title from being mistaken for a reported result.
More broadly, this record illustrates why statistical interpretation depends on outcome definitions, denominators, and analysis details, not only on a study’s purpose or enrollment. Without those elements, neither an effect estimate nor its precision can be assessed. The study’s feasibility question and its subsequent place before an accuracy-focused trial provide context, but they do not fill the missing outcome data or establish a detection advantage.
13. 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 principal limitation for interpreting this specific study is that the registry does not report numerical primary-outcome results. It states that positive biopsy samples for each approach were not available and that positive cores per approach were not determined. As a result, the record cannot support a detection estimate or a comparison of detection between targeted and standard biopsy.
The registry describes enrollment but does not identify the denominator used for the primary assessment, the number of evaluable biopsies, or the analysis population. The timeframe is stated as up to 2 years, but outcome timing and completeness are not detailed. Missing-data procedures, outcome adjudication, and the criteria for recurrent cancer detection are not reported in the registry record.
The study is classified as single group, with allocation not applicable and no masking. Although the record names both targeted and standard biopsy approaches, it cautions that these are not a like-for-like control comparison. Details that would clarify how the approaches related to participants or outcome assessment are not reported. The registry also does not provide a statistical analysis plan, sample-size justification, or reported primary-outcome analysis.
Finally, adverse-event fields contain zero entries for the listed categories, but the registry does not explain their denominators or ascertainment. Those entries should not be treated as evidence of complete safety follow-up or as a quantitative safety estimate. These limitations concern what can be concluded from the registry record; they do not establish what happened in the study beyond the information it records.
14. Related Tutorials
15. Related Statistical Calculators
16. Sources
- ClinicalTrials.gov: Fusion Targeted Biopsy of the Prostate — NCT02013414.
- Registry record last updated 2019-09-17; status last verified 2019-08.
- Results first posted 2019-09-17.
- 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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17. Record Summary
The registry describes a completed feasibility study of 3D ultrasound-guided prostate biopsy, sponsored by Emory University, with an enrollment of 9. The stated primary question was whether targeted biopsy could detect recurrent prostate cancer, over a timeframe of up to 2 years. The system was intended to use 3D ultrasound to guide and document biopsy and could fuse MRI or PET images with ultrasound images to target suspicious areas.
The study is classified as single group, with allocation not applicable and no masking. Although targeted and standard biopsy approaches are named, the registry cautions that they are not a like-for-like control comparison. The primary outcome description says positive-sample counts by approach were not determined or available. No numerical detection result, primary-outcome analysis, or statistical plan is reported in the registry record. The record therefore documents the feasibility aim and approach but does not quantify detection performance or comparative accuracy.