Optimizing Timing of rhPSMA-7.3 (18F) for Assessing Site(s) of Recurrent Disease Following Radical Prostatectomy: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Optimizing Timing of rhPSMA-7.3 (18F) for Assessing Site(s) of Recurrent Disease Following Radical Prostatectomy (NCT05678322), a na phase 3 study. The primary outcome is Positive PCa Screens at Baseline.

2. Clinical Question

The study concerns men whose prostate-specific antigen (PSA) level first becomes >0.2 ng/ml after radical prostatectomy. Its clinical question is whether rhPSMA-7.3 (18F) imaging identifies prostate cancer at the initial post-prostatectomy scan and, among people with a negative initial scan, whether a later scan identifies disease. The registry describes the diagnostic yield of the first and second studies as the comparison of interest.

The study also describes follow-up imaging for people with an initially negative scan. The brief summary states that they undergo another scan when PSA is > 0,5 ng/ml or one year after the initial PET study. The registry therefore frames the later scan as a way to assess subsequent detection after a negative baseline result, rather than as a control condition. The diagnostic question is about scan findings; it does not, by itself, establish the effect of imaging on later clinical outcomes.

3. Trial Design

This is a phase 3, single-group study sponsored by NYU Langone Health. The registry lists an enrollment of 26 and a status of active, not recruiting. Its listed start date is 2023-01-31 and its primary completion date is 2025-05-08. The allocation field is not applicable, and masking is listed as none. The record describes the condition as prostate cancer.

Participants are men following radical prostatectomy whose PSA first becomes >0.2 ng/ml. The arm description says participants receive baseline rhPSMA-7.3 (18F) MRI imaging within a month of enrollment and describes a second scan within a year of the initial scan. The brief summary adds that participants with a negative initial scan undergo a second scan when PSA is > 0,5 ng/ml or one year after the initial PET study. The registry’s wording should be read as a description of the planned sequence; it does not report how many participants completed the later scan or the timing actually achieved.

The listed interventions are an 18F-labeled PET diagnostic agent and PET MRI imaging. Participants with identifiable disease may be offered salvage intervention according to standard of care, with the intervention left to the investigator’s discretion. This is not a randomized comparison of imaging strategies or salvage interventions. Consequently, the observed diagnostic yield cannot be interpreted as a causal comparison between treatment groups.

The baseline analysis population is reported as 24 participants who underwent imaging. The enrollment figure is 26, but the reasons that the baseline analysis population is smaller are not reported in the registry record. The registry lists two outcome measures and no analyses. The primary outcome is the count of participants screening positive at baseline; the registry does not report its result.

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

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: A total of 24 participants underwent baseline imaging and were included in the baseline analysis.

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.

6. Primary Endpoint

The registry lists the primary outcome as Positive PCa Screens at Baseline, measured over Baseline.

The primary endpoint is the number of participants who screen positive for prostate cancer on the baseline rhPSMA-7.3 (18F) scan. It is a binary-outcome count: each participant’s scan is classified as positive or not positive, and the endpoint totals those with a positive screen. The measurement unit is participants, and the timeframe is baseline.

This endpoint is used to describe the diagnostic yield of the initial scan in the population being studied. In general, a positive-screen count is meaningful alongside its analysis denominator, because the count alone does not show how common positive findings were among those assessed. The registry identifies 24 participants as included in the baseline analysis, but does not report the number who screened positive. It also does not report an estimate of diagnostic accuracy against an independent reference standard. Thus, the stated endpoint addresses how many baseline screens were positive, not whether each finding was confirmed or whether imaging changed subsequent outcomes.

The registry describes the broader study objective as comparing the diagnostic yield of the first and second imaging studies. The primary endpoint listed, however, is specifically the baseline positive-screen count. A second-scan result, its analysis population, and a statistical comparison of the scan results are not reported in the registry record. The endpoint definition can therefore be described, but the baseline yield itself cannot be quantified from the posted results.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The primary outcome is a count of participants with a positive baseline screen. In statistical terms, this is a binary outcome summarized as the number meeting a defined condition. The complementary category is participants who do not screen positive, although the registry does not give either category’s observed count. The baseline analysis population is stated to be 24 participants who underwent imaging.

For a binary outcome, a count communicates how many observations fall into a category, while a proportion expresses that count relative to the assessed population. General explanation: the proportion helps readers understand the frequency of positive findings in the analyzed group, and a confidence interval communicates uncertainty around an estimate. Neither the positive count, a proportion, nor a confidence interval for the baseline endpoint is reported in the registry record. It would not be appropriate to reconstruct a result from the enrollment figure because enrollment and the baseline analysis population are not the same stated quantity.

The study’s broader objective involves diagnostic yield at two time points. General explanation: when the same participants may contribute observations at more than one time point, the results are related rather than independent. A statistical comparison should account for that relationship and define which participants contribute to each time point. Here, the second scan is described for participants with a negative first scan, so the later-scan group is selected based on the baseline finding. The registry does not report the number receiving the later scan, the number of positive results at that scan, or the statistical method used to compare first and second scan yield. No paired or other comparison method is reported in the registry record.

Study design also affects what can be inferred. This study has a single group and no randomized allocation. The imaging sequence is therefore not a randomized comparison of alternative schedules. General explanation: random assignment can help balance differences between comparison groups, while a single-group design primarily describes outcomes within the enrolled group. A change in scan findings across time would not, by itself, isolate the effect of scan timing from changes in participants’ disease status, PSA, or other factors. The registry’s stated objective is diagnostic yield, and its reported primary endpoint is the baseline positive-screen count.

What does an uncertainty interval add?

General explanation: an uncertainty interval places a range around an estimate to convey how compatible different values are with the observed data under the stated statistical method. It is not a guarantee that the true value lies within that range, and its interpretation depends on the analysis assumptions. No interval estimate or inferential analysis for the primary outcome is reported in the registry record. Since the primary positive-screen count is also absent, the size and precision of the baseline estimate cannot be evaluated from the posted results.

What do the sample-size assumptions describe?

The registry includes assumptions for planning illustrations: a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the effect to detect expressed as a stated fraction of the observed effect. These are described as planning illustrations rather than as the trial’s own design. The study itself is single-group, so the equal-allocation assumption does not describe its listed design. The registry does not report the sample-size justification used for this study, and it does not report a planned effect size or power calculation for the actual design. Any sample-size illustration is a planning aid, not observed power and not evidence that the study had a particular probability of finding an effect.

General explanation: power is a design property based on assumptions about an effect, variability, sample size, and analysis. It cannot be inferred from whether a result is statistically significant, and it is not a retrospective measure of whether a study’s result is reliable. No outcome analysis is listed in the registry, so there is no reported statistical test result to interpret. The registry also does not describe interim analyses, a prespecified statistical analysis plan, or a method for handling repeated imaging observations.

There are two outcome measures listed, but the details reported for the primary outcome concern the baseline positive-screen count. The other outcome’s definition and analysis are not reported in the registry record. The registry thus supports a description of the intended endpoint and study structure, but not a quantitative assessment of diagnostic yield or its statistical uncertainty.

10. Exact Estimates for Each Arm

No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.

R code and output

arm    <- c("Patients With PSA > 0.2 ng/ml Following Radical Pr")
n      <- c(24)
events <- c(6)
for (i in seq_along(n)) {
  ci <- binom.test(events[i], n[i])$conf.int          # Clopper-Pearson exact interval
  cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i])   # Bayesian, uniform Beta(1,1) prior
  wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
    c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
  cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
              100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}

ARM  Patients With PSA > 0.2 ng/ml Following Radical Pr  24  6  25.0  9.8  46.7  12.0  44.9  12.1  45.1

11. Multiplicity, Missing Data and Analysis Populations

The registry lists two outcome measures and no analyses. It identifies the baseline positive-screen count as the primary outcome, but the other outcome’s definition and the results for either measure are not reported in the registry record. The record does not describe a multiplicity adjustment, a hierarchy of hypothesis tests, or another method for controlling the chance of false-positive findings across multiple outcomes. Because no inferential analyses are listed, there are no reported p-values to assess in relation to multiplicity.

The baseline analysis includes 24 participants who underwent imaging, while enrollment is listed as 26. The reasons for the difference are not reported in the registry record. There is no description of missing baseline scans, excluded participants, withdrawals, or other reasons for non-inclusion. The number eligible for or completing the second scan is also not reported. No method for handling missing outcome data, such as exclusion, imputation, or sensitivity analysis, is described.

The stated baseline analysis population is the only outcome population explicitly identified. A separate analysis population for later imaging, safety follow-up, or any other endpoint is not described. The registry does not report whether analyses follow an intention-to-treat principle or another prespecified population definition. These omissions limit assessment of possible selection and missing-data effects. General explanation: when participants without observed outcomes differ from those with observed outcomes, results limited to observed cases may not represent the full enrolled group. The registry does not provide information that would establish whether such a concern applies.

12. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

The registry lists 24 participants at risk for serious adverse events, with zero affected. It also lists 24 participants at risk for other adverse events, with zero affected, and records zero deaths. No serious adverse-event terms are listed. These figures describe the recorded counts in the registry categories; they do not state the duration or completeness of safety observation.

A count of zero means no event in that category was recorded among the listed at-risk participants. General explanation: a zero count does not prove that the underlying risk is zero, and its interpretation depends on the number observed, the observation period, and how events were collected and classified. The registry does not report those additional details, nor does it provide event rates or uncertainty intervals. It also does not describe the timing or severity of non-serious events beyond the aggregate count.

These safety figures should be read separately from the diagnostic endpoint. They do not indicate how many scans were positive and do not establish the diagnostic yield of either imaging study. The registry records no deaths in the listed group, but does not report a separate analysis of cause or follow-up duration.

13. What the Result Does, and Does Not, Mean

The record establishes that the study was designed to examine rhPSMA-7.3 (18F) imaging after radical prostatectomy, with baseline imaging and a later scan described for participants whose initial scan is negative. Its primary endpoint is the count of participants with a positive baseline screen. The record also establishes that 24 participants underwent baseline imaging and were included in that analysis.

The central result needed to interpret baseline diagnostic yield—the number who screened positive—is not reported in the registry record. No proportion, confidence interval, or statistical test for that endpoint is reported. The number of participants who received the second scan and its positive-screen count are also not reported. As a result, the posted information does not quantify how often either scan identified disease or whether the later scan added detections.

The study’s single-group, sequential structure also sets limits on interpretation. A comparison of baseline and later findings would not be a randomized comparison of scan schedules. Participants considered for the later scan are selected on the basis of a negative baseline result, and the later scan is tied to PSA level or elapsed time in the study description. The registry does not report an analysis accounting for these features.

The recorded safety counts are zero serious adverse events, zero other adverse events, and zero deaths among 24 participants at risk in each listed category. The record does not state the safety observation period or provide uncertainty estimates. These counts describe the recorded categories and do not resolve the missing diagnostic results.

Accordingly, the registry supports an account of the study question, design, baseline analysis population, and recorded safety counts. It does not support a numerical conclusion about diagnostic yield, comparative performance of the scans, or clinical outcomes following imaging. Those results are not reported in the registry record.

14. Why This Trial Matters Statistically

This study raises a statistical question about repeated diagnostic assessment in a single group. The initial scan and the later scan are not simply interchangeable measurements from separately assigned groups: a later scan is described for participants with a negative initial result. This makes the definition of each analysis population important. Readers need to know how many people received each scan, which results were counted, and whether the comparison accounts for the relationship between measurements on the same participants.

The distinction between enrollment and analysis population also matters. Enrollment is listed as 26, while 24 participants are reported in the baseline analysis. Without reasons for the difference, readers cannot assess whether any exclusions or missing scans could affect the observed yield. Reporting the number assessed and the number with positive findings at each scan would be essential for understanding the descriptive result.

The study illustrates why an endpoint definition and an endpoint result are different pieces of information. The registry specifies what the primary count is intended to measure, but does not report the count itself. Without the count and an uncertainty estimate, statistical precision cannot be judged. A stated diagnostic objective alone does not establish the size or reliability of a finding.

Finally, the single-group design shapes the claims that could be supported even if results were reported. It can describe findings under the study’s imaging sequence, but it does not provide a randomized control comparison. The registry’s planning assumptions for sample-size illustrations should not be mistaken for the design actually listed or for evidence of observed power. These considerations make clear reporting of denominators, scan-specific outcomes, missingness, and analysis methods especially important for interpreting this kind of diagnostic study.

15. 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 in interpreting the posted record is that the primary outcome value is absent. Although the endpoint is defined as the number of positive baseline screens and 24 participants are said to be included in the baseline analysis, the number screening positive is not reported in the registry record. The record also does not give an uncertainty interval or inferential result.

The study’s wider objective concerns the yield of a first and second scan, but the later-scan result is not reported. The number of participants with a negative baseline scan, the number who underwent a second scan, the number of positive second scans, and the comparison method are not reported. The timing description allows for a second scan at a PSA threshold or after one year, but actual scan timing is not reported.

The registry lists 26 enrolled participants and 24 in the baseline analysis, without explaining the difference. This prevents assessment of exclusions or missing baseline imaging. It also does not describe the statistical analysis plan, handling of missing data, analysis populations beyond the stated baseline group, or any multiplicity procedure. No interim analyses are reported. The sample-size assumptions are identified as planning illustrations, not as the trial’s own design justification.

Finally, the single-group, unmasked design does not provide a randomized comparison of imaging schedules. The registry does not report an independent reference-standard analysis of diagnostic accuracy, nor does it report clinical outcomes attributable to the imaging strategy. These limitations mean the record can describe the intended question and available counts, but cannot establish comparative diagnostic performance or quantify the primary outcome.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Optimizing Timing of rhPSMA-7.3 (18F) for Assessing Site(s) of Recurrent Disease Following Radical Prostatectomy — NCT05678322.
• Registry record last updated 2026-03-25; status last verified 2026-03.
• Results first posted 2026-03-25.
• 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.

19. Record Summary

NCT05678322 is a phase 3, single-group study sponsored by NYU Langone Health of rhPSMA-7.3 (18F) imaging following radical prostatectomy. The listed enrollment is 26; 24 participants underwent baseline imaging and were included in the baseline analysis. The study is active, not recruiting, and has no masking or randomized allocation listed.

The primary endpoint is the number of participants with a positive prostate cancer screen at baseline. That result, the second-scan results, and statistical analyses are not reported in the registry record. The safety listing records zero serious adverse events, zero other adverse events, and zero deaths among 24 participants at risk in each category. Reasons for the difference between enrollment and the baseline analysis population, analysis methods, and missing-data procedures are not reported in the registry record.