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 The Role of 68Ga-PSMA-11 PET (Prostate Specific Membrane Antigen) in Surgery Guidance in Prostate Cancer (NCT04936334), a na phase 2 study. The primary outcome is Sensitivity of PSMA-PET and MRI Imaging Preoperatively for Predicting Extra-prostatic Extension.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04936334 |
| Phase | Phase 2 |
| Condition | Prostate Cancer |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 51 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Clinton Bahler |
| Results posted | Yes |
2. Clinical Question
Population
Men diagnosed with clinically significant prostate cancer who are scheduled for prostatectomy. The registry record describes an enrollment of 51 and follow-up until 12 mo after surgery.
Intervention
Preoperative 68Ga-PSMA-11 PET imaging. The record describes a 60minute PET exam and says surgery was generally performed within 1month of the scan.
Comparator
There is no separately assigned control group. The study aims to compare PSMA-PET performance with standard-of-care assessments, including MRI and clinical parameters such as PSA and pathology.
Primary question
How sensitive are preoperative PSMA-PET and MRI imaging for predicting extra-prostatic extension of cancer at the nerve bundles, using surgical pathology as the reference standard?
The clinical question links imaging before surgery with findings from the prostatectomy specimen. The registry describes whole-mount pathology as the gold standard for assessing extra-prostatic extension. It also identifies a broader aim: to quantify appropriate treatment changes directed by PET, with attention to preservation of structures important to genito-urinary function, and to assess quality-of-life changes from preoperative baseline.
These aims address related but distinct questions. Diagnostic sensitivity concerns how often imaging identifies extension that is present according to the reference standard. Treatment-change frequency concerns decisions made in response to imaging, while quality-of-life change concerns outcomes reported by patients. The record identifies sensitivity as the primary outcome and lists proper treatment changes for nerve sparing as a secondary outcome. It does not report numerical results for these questions, so the clinical value of the imaging strategy cannot be judged from the registry record alone.
3. Trial Design
This is a Phase 2 prospective pilot trial, listed as completed. It is a single-group study of a diagnostic test rather than a randomized comparison of treatment groups. The registry record lists allocation as not applicable and masking as none. Enrollment is recorded as 51. The study start date is 2021-06-11, and primary completion is recorded as 2022-07-18.
Participants were men diagnosed with clinically significant prostate cancer who were scheduled for prostatectomy. The intervention was a 68Ga-PSMA-11 PET scan before surgery. The record says participants were followed until 12 mo after surgery. It describes the PET exam as 60minute, says surgery was generally performed within 1month of the scan, and places pathology 5-10 days after surgery.
The study’s stated aims include assessing imaging performance for extra-prostatic extension against whole-mount pathology, comparing PSMA-PET with standard-of-care assessments, evaluating treatment changes directed by PET, and assessing quality-of-life changes from preoperative baseline. The named secondary outcome concerns the frequency of proper treatment changes for nerve sparing directed by PSMA-PET.
Because there is no separately assigned control arm, the study does not provide a randomized, between-group estimate of the effect of an imaging strategy. The comparison with standard-of-care assessments is an intended diagnostic comparison, not evidence of randomized allocation. The record does not report how many participants contributed data to each analysis, whether all participants received each assessment, or how missing observations were handled. It also does not report a detailed statistical analysis plan or a sample-size justification. Those omissions limit assessment of how the planned aims were translated into analysis.
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 | PSMA-PET and MRI in Men Scheduled for Prostatectomy |
|---|---|
| STARTED | 51 |
| COMPLETED | 50 |
| NOT COMPLETED | 1 |
Reasons for not completing this period:
| Reason | PSMA-PET and MRI in Men Scheduled for Prostatectomy |
|---|---|
| Metastatic disease found on PSMA-PET, surgery cancelled | 1 |
Analysis population for the primary outcome, as defined in the registry: Men diagnosed with prostate cancer often seek surgical treatment. Surgical treatment--radical prostatectomy--is currently guided by clinical parameters (PSA, pathology) and MRI imaging. These men often have considerable concerns about the balance of cancer control and quality of life after the surgery. There were 100 prostate lobes examined with 2 lobes per patient. One patient was enrolled but did not complete study procedures.
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 | PSMA-PET and MRI in Men Scheduled for Prostatectomy |
|---|---|---|
| Participants analysed | 50 | |
| Age, Continuous | years | 61.5 (58 to 67) |
| Sex: Female, Male: Female | Participants | 0 |
| Sex: Female, Male: Male | Participants | 50 |
| 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 | 6 |
| Race (NIH/OMB): White | Participants | 42 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 2 |
| PSA | ng/mL | 7.0 (5.5 to 8.7) |
| Gleason Grade-group, final pathology: Grade-Group 1 (Gleason) | participants | 1 |
| Gleason Grade-group, final pathology: Grade-Group 2 (Gleason) | participants | 15 |
| Gleason Grade-group, final pathology: Grade-Group 3 (Gleason) | participants | 15 |
| Gleason Grade-group, final pathology: Grade-Group 4 (Gleason) | participants | 9 |
| Gleason Grade-group, final pathology: Grade-Group 5 | participants | 10 |
| Pathologic stage (T): pT2 | participants | 25 |
| Pathologic stage (T): pT3a | participants | 12 |
| Pathologic stage (T): pT3b | participants | 13 |
| Pathologic stage (T): pT4 | participants | 0 |
| Pathologic stage (N) | Participants | 8 |
6. Primary Endpoint
The registry lists the primary outcome as Sensitivity of PSMA-PET and MRI Imaging Preoperatively for Predicting Extra-prostatic Extension, measured over The patients underwent a 60minute PET exam. The surgery was generally performed within 1month of the PET scan. The pathology was done 5-10 days after the surgery..
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | 95% Confidence Interval |
| Unit | percentage |
| Endpoint classification | not reduced to a single comparison |
The primary outcome is titled sensitivity of preoperative PSMA-PET and MRI imaging for predicting extra-prostatic extension. Its description focuses on detecting cancer extension at the nerve bundles. The registry identifies percentage as the unit and a 95% confidence interval as the dispersion measure, while describing the parameter as a number. It does not report a numerical sensitivity estimate or confidence interval.
Sensitivity is the proportion of people who have the target condition according to a reference standard and whose test identifies it. In this trial, the target finding is extra-prostatic extension, and the registry names whole-mount pathology after surgery as the gold standard. Sensitivity is relevant because the study asks whether preoperative imaging can identify extension before the operation, when surgical planning is still being considered. It does not, by itself, describe how often a positive imaging finding is correct; that is a different diagnostic property. Nor does sensitivity alone establish whether an imaging result leads to an appropriate treatment change or affects quality of life.
The endpoint therefore addresses one part of the broader clinical question: detection of extension at the nerve bundles. The record does not provide the underlying diagnostic classifications, a numerical estimate, or the precision of that estimate. Without those results, the intended endpoint can be explained, but its observed performance cannot be assessed.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record describes a prospective pilot study designed to evaluate preoperative 68Ga-PSMA-11 PET in men scheduled for prostatectomy. Its central diagnostic aim is to assess sensitivity for extra-prostatic extension at the nerve bundles, with surgical pathology serving as the reference standard. The stated broader aims include comparison with standard-of-care assessments, treatment changes directed by PET, and quality-of-life changes.
The record does not report a numerical primary outcome. Although it identifies sensitivity as the primary measure and specifies a 95% confidence interval, neither the estimate nor its interval is included. It also does not report counts of positive and negative imaging findings against pathology. Consequently, the posted results do not establish how often imaging detected extension, how uncertain that estimate would be, or how imaging compared with the other assessments.
The design matters when interpreting the study. This is a single-group diagnostic pilot, not a randomized comparison with a control arm. The aim of comparing imaging performance with standard-of-care assessments should not be mistaken for random assignment to different diagnostic strategies. Any comparison would require results for the relevant assessments and an account of how participants and observations were included; those details are not reported in the registry record.
The record lists enrollment of 51, but enrollment alone does not indicate how many participants had complete imaging and pathology data for the primary analysis. The analysis population, handling of missing data, and any exclusions are not reported in the registry record. Likewise, the statistical plan, including any rules for estimating sensitivity or comparing tests, is not reported. These gaps prevent readers from assessing whether the available observations match the intended endpoint or whether a comparison was prespecified and carried out as intended.
The endpoint’s intended precision measure is a confidence interval. In general, an interval communicates uncertainty around an estimate, but no interval is available to interpret in this record. The registry also lists a secondary outcome concerning proper nerve-sparing treatment changes, yet does not give a numerical result for it. Quality-of-life results and other outcome results are also not presented in the record. Thus, the record describes important research questions and a completed study, but does not supply the outcome evidence needed to answer them.
These points are not evidence for or against the imaging approach. They distinguish the study’s aims from its posted results. A completed status indicates that the registry lists the trial as completed; it does not replace outcome estimates, uncertainty intervals, or analytic details. Clinical conclusions about diagnostic accuracy, treatment changes, or quality of life cannot be drawn from the registry record’s descriptive entries alone.
9. Statistical Methods Explained
The statistical interpretation of this trial begins with its design and the kind of outcome it set out to measure. It is a prospective, single-group diagnostic pilot, with preoperative imaging and pathology after prostatectomy. The primary outcome concerns sensitivity for extra-prostatic extension at the nerve bundles. The registry identifies whole-mount pathology as the reference standard and specifies a 95% confidence interval, but does not report the estimate or the underlying classifications.
What does sensitivity describe?
In general, sensitivity describes the ability of a test to identify people who have a target finding according to a chosen reference standard. A finding is counted as detected when the imaging assessment indicates extension and the reference standard also identifies extension. Missed cases are those in which the reference standard identifies extension but the imaging assessment does not. Sensitivity is calculated among people who have the target finding according to the reference standard; it is not calculated among everyone who was enrolled.
For this study, pathology after surgery is the stated reference standard for extra-prostatic extension. The primary description narrows the target finding to extension at the nerve bundles. Interpretation therefore depends on having both an imaging classification and a pathology classification for the relevant participants. The registry does not report those classifications or the number contributing to the primary analysis, so the sensitivity calculation cannot be reconstructed from the record.
Why use a reference standard?
In general, diagnostic accuracy requires a way to determine whether the condition being assessed is actually present. A reference standard provides that basis for classifying test findings as detected or missed. The trial’s summary identifies whole-mount pathology as the gold standard. This makes the timing of assessments important: imaging is preoperative, while pathology follows surgery. The record describes surgery as generally occurring within 1month of PET and pathology as occurring 5-10 days after surgery.
A reference standard is not automatically free of limitations. Its interpretation, completeness, and relationship to the imaging assessment can affect the accuracy estimate. The registry record does not describe pathology assessment procedures, whether readers were masked to imaging findings, or how uncertain or unavailable pathology results were treated. Those details are not reported in the registry record and should not be inferred from the stated reference standard alone.
What does a confidence interval add?
In general, a confidence interval expresses the statistical uncertainty around an estimate. It helps readers distinguish a relatively precise estimate from one that is compatible with a broad range of values. The registry names a 95% confidence interval for the primary outcome, but posts no interval or point estimate. No conclusion about precision is therefore possible. A confidence interval would not, by itself, resolve issues such as bias, incomplete data, or whether the analyzed participants represent the intended population.
How should the comparison be understood?
The registry states an aim to compare PSMA-PET performance with standard-of-care assessments. It also describes MRI and clinical parameters, including PSA and pathology, in the context of current surgical guidance. This does not make the study a randomized comparison. The design is single-group, and there is no separately assigned comparator arm. In general, evaluating two diagnostic approaches can require paired information from the same participants and a clear method for comparing their classifications. The record does not report the detailed comparison method or its results.
Diagnostic metrics answer different questions. Sensitivity addresses detection among people with the target finding. Other metrics can describe how often a positive result is correct, how often a negative result is correct, or how well test results distinguish people with and without the finding. The registry record does not provide numerical results for these measures. They should not be inferred from the endpoint title or from the fact that a comparison was planned.
Why is the pilot design relevant?
In general, a pilot study can describe feasibility and generate estimates for future research, but its designation does not guarantee that a particular sample size is adequate for every diagnostic question. The registry record does not report a sample-size justification, assumptions about expected sensitivity, or a precision target. Enrollment of 51 should therefore be read as the recorded enrollment, not as proof that the study had sufficient precision to settle its aims. The posted record also does not report an interim-analysis plan or detailed statistical analysis plan.
The record lists one named secondary outcome about proper nerve-sparing treatment changes and states that there are 3 outcome measures overall. It reports one analysis. Those entries do not reveal whether outcomes were prioritized in a prespecified hierarchy, whether multiple comparisons were adjusted, or which analysis populations were used. Such details are not reported in the registry record. Statistical interpretation must remain limited to the study design and outcomes as described, rather than assuming methods that are not documented.
10. Multiplicity, Missing Data and Analysis Populations
The registry record identifies a primary sensitivity outcome and one named secondary outcome concerning proper treatment changes for nerve sparing directed by PSMA-PET. It also lists 3 outcome measures overall and reports one analysis. The record does not describe an outcome hierarchy, a multiplicity adjustment, or a prespecified approach to controlling the chance of false-positive findings across outcomes. The absence of those details does not show that no such approach was used; it means the approach is not reported in the registry record.
Missing-data handling is also not reported. The enrollment entry gives 51, but the record does not state how many participants had evaluable imaging, surgery, and pathology data for the primary endpoint. It does not explain whether participants with unavailable or indeterminate results were excluded, classified in a particular way, or included in a sensitivity analysis. Those choices can affect a diagnostic estimate because the primary outcome depends on both imaging and reference-standard information.
The analysis population is not described beyond the trial’s population of men diagnosed with clinically significant prostate cancer who were scheduled for prostatectomy. The registry does not state whether every enrolled participant entered each outcome analysis, whether any participants were excluded, or whether analyses followed a defined intention-to-diagnose or complete-case approach. The statistical analysis plan is not reported in the registry record.
These omissions limit reproducibility and make it difficult to assess the relationship between enrollment and the analyzed data. They also prevent evaluation of whether missing observations or multiple outcome assessments could have influenced reported estimates. Since no numerical primary or secondary results are posted, the size and direction of any such influence cannot be evaluated.
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 |
|---|---|---|---|
| PSMA-PET and MRI in Men Scheduled for Prostatectomy | 0 | 51 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| PSMA-PET and MRI in Men Scheduled for Prostatectomy | 0 of 51 |
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 |
|---|---|
| PSMA-PET and MRI in Men Scheduled for Prostatectomy | 0 of 51 |
The registry lists a safety group titled PSMA-PET and MRI in Men Scheduled for Prostatectomy. It records 51 participants at risk for serious adverse events and 0 affected. The same group lists 51 at risk for other adverse events and 0 affected, with 0 deaths. No serious adverse-event terms are listed.
These entries describe what the registry reports; they are not, by themselves, a complete demonstration that no adverse events occurred. The record does not specify the safety observation period, the method used to collect events, the event definitions, or whether all participants had complete safety follow-up. The listed figures should therefore be read as recorded counts within the registry’s safety reporting, rather than as a guarantee of absence of risk.
The trial concerns a diagnostic imaging procedure in a surgical population, but the safety entries do not provide a comparison group or a detailed account of attribution. The record does not indicate whether any event was considered related to the scan, surgery, or another cause. No comparative safety conclusion can be drawn from these counts alone.
12. What the Result Does, and Does Not, Mean
The registry record shows that a prospective Phase 2 pilot trial was completed to study preoperative 68Ga-PSMA-11 PET in men scheduled for prostatectomy. It identifies a diagnostic question about sensitivity for extra-prostatic extension at the nerve bundles, with whole-mount pathology as the reference standard. It also describes aims related to comparison with standard-of-care assessments, treatment changes, and quality of life.
What the record does not show is the numerical primary result. There is no posted sensitivity estimate, confidence interval, or count of imaging and pathology classifications. The record also contains no numerical result for the named secondary outcome. As a result, it is not possible to describe how well imaging detected extension, how precise an estimate was, or how often PET-directed treatment changes were considered proper.
In general, a diagnostic sensitivity estimate addresses detection among people whose disease finding is confirmed by the reference standard. It does not answer every question about diagnostic performance or patient benefit. A high or low sensitivity, if reported, would need to be considered alongside other measures, the study population, the quality of the reference standard, missing data, and the consequences of false-positive and false-negative findings. None of those considerations can substitute for the absent trial results.
The design also limits what kind of causal conclusion could be drawn. This is a single-group study, not a randomized comparison of imaging strategies or treatments. The stated comparison with standard-of-care assessments is not a substitute for a separately assigned control group, and no comparison results are reported. The registry’s completed status indicates study status, not proof of a particular diagnostic or clinical effect.
Accordingly, the record supports a description of the study question, population, intervention, and intended outcomes. It does not support a conclusion that the imaging strategy did or did not improve cancer detection, surgical decisions, preservation of function, or quality of life. Those outcomes require numerical findings and enough analytic detail to judge their uncertainty and completeness.
13. Why This Trial Matters Statistically
This trial is statistically interesting because it connects an imaging test performed before surgery with a reference standard obtained afterward. The primary question is diagnostic: whether preoperative imaging identifies extra-prostatic extension at the nerve bundles when compared with pathology. The registry also frames imaging as potentially relevant to surgical planning, especially decisions involving preservation of surrounding structures important to genito-urinary function.
These are linked but not interchangeable statistical questions. Sensitivity describes detection of a target finding among those in whom the reference standard confirms it. Treatment-change frequency describes clinical decisions made in response to imaging. Quality-of-life change describes patient outcomes over time. A result for one cannot stand in for results on the others. The registry lists these aims but does not provide numerical outcome results.
The study also illustrates why design labels matter. A prospective, single-group pilot can organize the assessment of diagnostic performance and planned decision changes, but it is not a randomized comparison of competing strategies. The intended comparison with standard-of-care assessments must be interpreted through the actual analysis method and data structure, which are not reported. The registry record does not provide enough detail to assess whether diagnostic results were evaluated in a paired manner or how uncertainty in a comparison was handled.
For readers, the key statistical distinction is between an outcome being named and an outcome being reported. The record specifies a primary measure and a confidence-interval approach, but does not give the estimate, interval, or underlying counts. Without those, neither performance nor precision can be judged. The study’s completed status and recorded enrollment are not substitutes for results. This makes the registry useful for understanding the intended research question, while leaving the central quantitative answer unavailable in the 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 principal limitation for interpreting this trial record is that it does not report the numerical primary outcome. Although the registry identifies sensitivity and a 95% confidence interval, it provides no estimate, interval, or diagnostic counts. No numerical result is posted for the named secondary outcome either. This prevents assessment of observed performance and uncertainty.
The study is a single-group pilot without a separately assigned control arm. Its aim to compare PSMA-PET with standard-of-care assessments does not amount to randomized allocation. The detailed comparison method, the results of any comparison, and the analysis population are not reported in the registry record. Consequently, the extent to which imaging approaches can be compared on equivalent participant data is unclear.
The record describes whole-mount pathology as the gold standard but does not report details of pathology review, reader masking, indeterminate classifications, or missing reference-standard data. It also does not explain whether all enrolled participants had complete imaging and pathology information. These are relevant because sensitivity depends on classifying both the imaging result and the reference-standard finding.
The registry does not report the statistical analysis plan, sample-size justification, handling of missing data, or approach to multiplicity. Nor does it explain whether analyses followed a defined analysis population or how exclusions were handled. The stated enrollment of 51 cannot establish how many participants contributed to each outcome or how precise the estimates would be.
Finally, the study’s broader aims include treatment changes and quality-of-life changes, but the registry record does not provide numerical results for these outcomes. The safety entries list zero affected for serious and other adverse events and zero deaths, but do not specify the safety observation period or collection procedures. These gaps constrain interpretation of both clinical outcomes and safety reporting.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: The Role of 68Ga-PSMA-11 PET (Prostate Specific Membrane Antigen) in Surgery Guidance in Prostate Cancer — NCT04936334.
- Registry record last updated 2023-08-03; status last verified 2023-08.
- Results first posted 2023-07-27.
- 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
The record describes NCT04936334, a completed Phase 2 prospective pilot trial titled The Role of 68Ga-PSMA-11 PET (Prostate Specific Membrane Antigen) in Surgery Guidance in Prostate Cancer. It lists a single-group design, no masking, and enrollment of 51 men diagnosed with clinically significant prostate cancer who were scheduled for prostatectomy.
The intervention was preoperative 68Ga-PSMA-11 PET. The primary outcome concerns sensitivity of PSMA-PET and MRI imaging for predicting extra-prostatic extension at the nerve bundles, with pathology identified as the reference standard. Other stated aims concern PET-directed treatment changes and quality of life.
The registry record does not report a numerical primary estimate or confidence interval, nor numerical results for the named secondary outcome. It lists 0 serious adverse events, 0 other adverse events, and 0 deaths. The analysis plan, missing-data methods, and analysis populations are not reported in the registry record.